FROM: U.S. STATE DEPARTMENT
Success of Northern Ireland Talks
Press Statement
John Kerry
Secretary of State
Washington, DC
December 23, 2014
The United States warmly welcomes that announcement today of an agreement among Northern Ireland's political parties, facilitated by the U.K. and Irish governments.
This is statesmanship, pure and simple, and leadership by all parties to break a political impasse and avoid a fiscal crisis by resolving complex budgetary and welfare issues. The agreement reforms institutional arrangements, which will improve governance in Northern Ireland, and advances Northern Ireland’s peace process by establishing new institutions to deal with the often divisive legacy of the past – including a Historical Investigations Unit, an Independent Commission for Information Retrieval, an Implementation and Reconciliation Group, and an Oral History Archive. The agreement on legacy issues is based largely on negotiations led last year by former Special Envoy for Northern Ireland Richard Haass.
I commend the parties for working together through some very contentious issues – and finding solutions that will promote a more peaceful and hopeful future for the people of Northern Ireland. The agreement will now go through party structures for endorsement.
The U.K. Government also played a critical role in the talks’ success by agreeing to provide financial support, including new funding to implement the arrangements for dealing with legacy issues and to promote shared and integrated education.
I applaud the parties and the two governments for securing this agreement and pledge America’s full political support for the new arrangements. I'm also particularly grateful to my Personal Representative, Senator Gary Hart, and his Deputy Greg Burton, whose deep engagement helped ensure the success of the talks. I know Senator Hart looks forward to continuing his efforts next year in support of a peaceful and prosperous Northern Ireland, and I am very lucky to have Gary devoting his time to this effort.
Tuesday, December 23, 2014
SECRETARY KERRY'S STATEMENT ON INDIAN OCEAN TSUNAMI TENTH ANNIVERSARY
FROM: U.S. STATE DEPARTMENT
Marking the Tenth Anniversary of the Indian Ocean Tsunami
Press Statement
John Kerry
Secretary of State
Washington, DC
December 22, 2014
I’ll never forget hearing the news of the tsunami that struck in the Indian Ocean 10 years ago. The images were gut-wrenching: entire towns razed from Indonesia to Somalia; raging waters sweeping away people’s homes; hundreds of thousands killed and many more separated from their families.
Today of all days, we pause to remember those we lost—from farmers and fishers to travelers from our own lands. I know that there are no words to express such a horrific loss. There’s no way to wipe away the pain of parents who lost a child, or children who lost their parents and were forced to assume adult responsibilities at a tender age.
We recognize the millions of people who contributed to the recovery effort. And we honor those who have continued to work in the years since to help the victims pick up the pieces and rebuild their communities. The tsunami was one of the worst we have ever seen, but it brought out the best in all of us.
It also sounded a warning. We know that many regions are already suffering historic floods and rising sea levels. And scientists have been saying for years that climate change could mean more frequent and disastrous storms, unless we stop and reverse course. Last year I visited the Philippines and saw the devastation of Typhoon Haiyan. It is incomprehensible that that kind of storm – or worse – could become the norm. The time to act on climate change is now – before it’s too late to heed the warning.
On this day of reflection, we mourn with our friends in Asia and Africa who were affected by this terrible disaster. We commit to the hard work still ahead to help the region build safer, more resilient communities. And we pledge our best efforts to leave our children and grandchildren a safer and more sustainable planet. Future generations are counting on us.
Marking the Tenth Anniversary of the Indian Ocean Tsunami
Press Statement
John Kerry
Secretary of State
Washington, DC
December 22, 2014
I’ll never forget hearing the news of the tsunami that struck in the Indian Ocean 10 years ago. The images were gut-wrenching: entire towns razed from Indonesia to Somalia; raging waters sweeping away people’s homes; hundreds of thousands killed and many more separated from their families.
Today of all days, we pause to remember those we lost—from farmers and fishers to travelers from our own lands. I know that there are no words to express such a horrific loss. There’s no way to wipe away the pain of parents who lost a child, or children who lost their parents and were forced to assume adult responsibilities at a tender age.
We recognize the millions of people who contributed to the recovery effort. And we honor those who have continued to work in the years since to help the victims pick up the pieces and rebuild their communities. The tsunami was one of the worst we have ever seen, but it brought out the best in all of us.
It also sounded a warning. We know that many regions are already suffering historic floods and rising sea levels. And scientists have been saying for years that climate change could mean more frequent and disastrous storms, unless we stop and reverse course. Last year I visited the Philippines and saw the devastation of Typhoon Haiyan. It is incomprehensible that that kind of storm – or worse – could become the norm. The time to act on climate change is now – before it’s too late to heed the warning.
On this day of reflection, we mourn with our friends in Asia and Africa who were affected by this terrible disaster. We commit to the hard work still ahead to help the region build safer, more resilient communities. And we pledge our best efforts to leave our children and grandchildren a safer and more sustainable planet. Future generations are counting on us.
REMARKS: DEPUTY AG COLE ON ALSTON BRIBERY CASE
FROM: U.S. JUSTICE DEPARTMENT
Remarks for Deputy Attorney General James M. Cole Press Conference Regarding Alstom Bribery Plea
Washington, DCUnited States ~ Monday, December 22, 2014
I am joined today by Assistant Attorney General Leslie Caldwell, of the Justice Department’s Criminal Division; First Assistant United States Attorney Michael Gustafson, of the District of Connecticut; and Executive Assistant Director Robert Anderson Jr., of the FBI. We are here to announce a historic law enforcement action that marks the end of a decade-long transnational bribery scheme – a scheme that was both concocted and concealed by Alstom, a multinational French company, and its subsidiaries in Switzerland, Connecticut, and New Jersey.
Today, those companies admit that, from at least 2000 to 2011, they bribed government officials and falsified accounting records in connection with lucrative power and transportation projects for state-owned entities across the globe. They used bribes to secure contracts in Indonesia, Egypt, Saudi Arabia, and the Bahamas. Altogether, Alstom paid tens of millions of dollars in bribes to win $4 billion in projects – and to secure approximately $300 million in profit for themselves.
Such rampant and flagrant wrongdoing demands an appropriately strong law enforcement response. Today, I can announce that the Justice Department has filed a two-count criminal information in the U.S. District Court for the District of Connecticut, charging Alstom with violating the Foreign Corrupt Practices Act, or FCPA, by falsifying its books and records and failing to implement adequate internal controls. Alstom has agreed to plead guilty to these charges, to admit its criminal conduct, and to pay a criminal penalty of more than $772 million. If approved by the court next year, this will be the largest foreign bribery penalty in the history of the United States Department of Justice.
In addition, I can announce that Alstom’s Swiss subsidiary is pleading guilty to conspiring to violate the FCPA. And the company’s two American subsidiaries have entered into deferred prosecution agreements and admitted that they conspired to violate the FCPA.
Alstom’s corruption scheme was sustained over more than a decade and across several continents. It was breathtaking in its breadth, its brazenness, and its worldwide consequences. And it is both my expectation – and my intention – that the comprehensive resolution we are announcing today will send an unmistakable message to other companies around the world: that this Department of Justice will be relentless in rooting out and punishing corruption to the fullest extent of the law, no matter how sweeping its scale or how daunting its prosecution. Let me be very clear: corruption has no place in the global marketplace. And today’s resolution signals that the United States will continue to play a leading role in its eradication.
The investigation and prosecution of Alstom and its subsidiaries have been exceedingly complex – and they have required the utmost skill and tenacity on the part of a wide consortium of law enforcement officials throughout the country and across the globe. I want to thank the Criminal Division’s Fraud Section and Office of International Affairs; the U.S. Attorney’s Offices in Connecticut, Maryland, and New Jersey; the FBI’s Washington Field Office and its Resident Agency in Meriden, Connecticut; the Corruption Eradication Commission in Indonesia; the Office of the Attorney General in Switzerland; the Serious Fraud Office in the United Kingdom; as well as authorities in Germany, Italy, Singapore, Saudi Arabia, Cyprus, and Taiwan, for their tireless efforts to advance this matter. The remarkable cross-border collaboration that these agencies made possible has led directly to today’s historic resolution. And this outcome demonstrates our unwavering commitment to ending corporate bribery and international corruption. Our hope is that this announcement will serve as an inspiration – and a model – for future efforts.
At this time, I’d like to introduce Assistant Attorney General [Leslie] Caldwell, who will provide additional details on today’s announcement.
Remarks for Deputy Attorney General James M. Cole Press Conference Regarding Alstom Bribery Plea
Washington, DCUnited States ~ Monday, December 22, 2014
I am joined today by Assistant Attorney General Leslie Caldwell, of the Justice Department’s Criminal Division; First Assistant United States Attorney Michael Gustafson, of the District of Connecticut; and Executive Assistant Director Robert Anderson Jr., of the FBI. We are here to announce a historic law enforcement action that marks the end of a decade-long transnational bribery scheme – a scheme that was both concocted and concealed by Alstom, a multinational French company, and its subsidiaries in Switzerland, Connecticut, and New Jersey.
Today, those companies admit that, from at least 2000 to 2011, they bribed government officials and falsified accounting records in connection with lucrative power and transportation projects for state-owned entities across the globe. They used bribes to secure contracts in Indonesia, Egypt, Saudi Arabia, and the Bahamas. Altogether, Alstom paid tens of millions of dollars in bribes to win $4 billion in projects – and to secure approximately $300 million in profit for themselves.
Such rampant and flagrant wrongdoing demands an appropriately strong law enforcement response. Today, I can announce that the Justice Department has filed a two-count criminal information in the U.S. District Court for the District of Connecticut, charging Alstom with violating the Foreign Corrupt Practices Act, or FCPA, by falsifying its books and records and failing to implement adequate internal controls. Alstom has agreed to plead guilty to these charges, to admit its criminal conduct, and to pay a criminal penalty of more than $772 million. If approved by the court next year, this will be the largest foreign bribery penalty in the history of the United States Department of Justice.
In addition, I can announce that Alstom’s Swiss subsidiary is pleading guilty to conspiring to violate the FCPA. And the company’s two American subsidiaries have entered into deferred prosecution agreements and admitted that they conspired to violate the FCPA.
Alstom’s corruption scheme was sustained over more than a decade and across several continents. It was breathtaking in its breadth, its brazenness, and its worldwide consequences. And it is both my expectation – and my intention – that the comprehensive resolution we are announcing today will send an unmistakable message to other companies around the world: that this Department of Justice will be relentless in rooting out and punishing corruption to the fullest extent of the law, no matter how sweeping its scale or how daunting its prosecution. Let me be very clear: corruption has no place in the global marketplace. And today’s resolution signals that the United States will continue to play a leading role in its eradication.
The investigation and prosecution of Alstom and its subsidiaries have been exceedingly complex – and they have required the utmost skill and tenacity on the part of a wide consortium of law enforcement officials throughout the country and across the globe. I want to thank the Criminal Division’s Fraud Section and Office of International Affairs; the U.S. Attorney’s Offices in Connecticut, Maryland, and New Jersey; the FBI’s Washington Field Office and its Resident Agency in Meriden, Connecticut; the Corruption Eradication Commission in Indonesia; the Office of the Attorney General in Switzerland; the Serious Fraud Office in the United Kingdom; as well as authorities in Germany, Italy, Singapore, Saudi Arabia, Cyprus, and Taiwan, for their tireless efforts to advance this matter. The remarkable cross-border collaboration that these agencies made possible has led directly to today’s historic resolution. And this outcome demonstrates our unwavering commitment to ending corporate bribery and international corruption. Our hope is that this announcement will serve as an inspiration – and a model – for future efforts.
At this time, I’d like to introduce Assistant Attorney General [Leslie] Caldwell, who will provide additional details on today’s announcement.
SEVEN DAY TRAIL ENDS WITH CONVICTION OF DOMINICAN DRUG TRAFFICKER
FROM: U.S. JUSTICE DEPARTMENT
Friday, December 19, 2014
Jury Convicts Dominican Drug Trafficker Following Seven-Day Trial
BOSTON – A Dominican man, who most recently resided in Salem, was convicted yesterday of participating in a North Shore drug trafficking conspiracy.
Jaime Aristy, a/k/a Junito, 29, was convicted following a seven-day jury trial for conspiracy to possess with intent to distribute and distribution of cocaine, a Schedule II controlled substance. In November 2012, Aristy was indicted. U.S. District Court Judge Denise J. Casper scheduled sentencing for March 25, 2015.
Aristy was one of eleven defendants charged with participation in a large-scale cocaine trafficking conspiracy between 2009 and 2012. The conspiracy included several members of the same family, including Jaime Aristy, who were involved in the distribution of multi-kilogram quantities of cocaine in Lynn, Salem, and Peabody. The investigation included court-authorized wiretaps as well as the seizure of kilograms of cocaine, more than $100,000 in currency, and drug paraphernalia used by the criminal organization. On Sept. 1, 2011, Aristy was arrested following a motor vehicle stop in Salem during which law enforcement officers recovered more than $93,000 in cash that was stashed in a shoe box on the back seat of the car, two cell phones used by the drug organization, and a drug ledger that reflected a series of drug transactions involving multiple kilograms of cocaine and tens of thousands of dollars.
The charging statute provides a sentence of no greater than 20 years in prison and a minimum of three years of supervised release. Actual sentences for federal crimes are typically less than the maximum penalties. Sentences are imposed by a federal district court judge based upon the U.S. Sentencing Guidelines and other statutory factors.
United States Attorney Carmen M. Ortiz; Daniel J. Kumor, Special Agent in Charge of the Bureau of Alcohol, Tobacco, Firearms & Explosives, Boston Field Division; and Michael J. Ferguson, Special Agent in Charge of the Drug Enforcement Administration, Boston Field Division, made the announcement today. The Salem Police Department and the Massachusetts State Police also assisted with the investigation. The case was tried by Linda M. Ricci and David J. D'Addio of Ortiz’s Drug Task Force Unit.
Friday, December 19, 2014
Jury Convicts Dominican Drug Trafficker Following Seven-Day Trial
BOSTON – A Dominican man, who most recently resided in Salem, was convicted yesterday of participating in a North Shore drug trafficking conspiracy.
Jaime Aristy, a/k/a Junito, 29, was convicted following a seven-day jury trial for conspiracy to possess with intent to distribute and distribution of cocaine, a Schedule II controlled substance. In November 2012, Aristy was indicted. U.S. District Court Judge Denise J. Casper scheduled sentencing for March 25, 2015.
Aristy was one of eleven defendants charged with participation in a large-scale cocaine trafficking conspiracy between 2009 and 2012. The conspiracy included several members of the same family, including Jaime Aristy, who were involved in the distribution of multi-kilogram quantities of cocaine in Lynn, Salem, and Peabody. The investigation included court-authorized wiretaps as well as the seizure of kilograms of cocaine, more than $100,000 in currency, and drug paraphernalia used by the criminal organization. On Sept. 1, 2011, Aristy was arrested following a motor vehicle stop in Salem during which law enforcement officers recovered more than $93,000 in cash that was stashed in a shoe box on the back seat of the car, two cell phones used by the drug organization, and a drug ledger that reflected a series of drug transactions involving multiple kilograms of cocaine and tens of thousands of dollars.
The charging statute provides a sentence of no greater than 20 years in prison and a minimum of three years of supervised release. Actual sentences for federal crimes are typically less than the maximum penalties. Sentences are imposed by a federal district court judge based upon the U.S. Sentencing Guidelines and other statutory factors.
United States Attorney Carmen M. Ortiz; Daniel J. Kumor, Special Agent in Charge of the Bureau of Alcohol, Tobacco, Firearms & Explosives, Boston Field Division; and Michael J. Ferguson, Special Agent in Charge of the Drug Enforcement Administration, Boston Field Division, made the announcement today. The Salem Police Department and the Massachusetts State Police also assisted with the investigation. The case was tried by Linda M. Ricci and David J. D'Addio of Ortiz’s Drug Task Force Unit.
5 CHARGED IN LIFE INSURANCE POLICIES FRAUD SCHEME
FROM: U.S. JUSTICE DEPARTMENT
Department of Justice
U.S. Attorney’s Office
Northern District of California
FOR IMMEDIATE RELEASE
Thursday, December 18, 2014
Five Defendants Charged In Fraudulent Life Insurance Policies Scheme
SAN FRANCISCO – Behnam Halali, Ernesto Magat, Kraig Jilge, Karen Gagarin, and Alomkone Soundara, a/k/a Alex Soundara, were charged in an indictment unsealed yesterday in federal court in connection with a scheme involving fraudulent life insurance policies while each was employed at the American Income Life Insurance Company (AIL), announced U.S. Attorney Melinda Haag, FBI Special Agent in Charge David J. Johnson, Internal Revenue Service, Criminal Investigation, Acting Special Agent in Charge Andrew Toth, and Commissioner Dave Jones of the California Department of Insurance.
According to the indictment, the defendants participated in a scheme involving the submission of applications for life insurance policies on behalf of people who did not know that a policy was applied for or issued in their name and/or did not want a life insurance policy. The defendants then shared the commissions and bonuses issued by AIL in connection with the fraudulent policies. The indictment alleges that the defendants paid recruiters to find people willing to take medical exams in exchange for approximately $100, and then took the personal information associated with those people and submitted applications for life insurance in their names, in many cases without the individuals’ knowledge. The defendants also allegedly paid people to participate in a fictitious survey of a medical exam company, and took the personal information associated with those people and submitted applications for life insurance, in many cases without the individuals’ knowledge. In some cases, the defendants allegedly created phony driver’s licenses so that they and their co-conspirators could take medical exams purporting to be the applicants. The defendants opened hundreds of bank accounts to fund the premiums on the fraudulent policies, and typically paid one to four months of premiums before letting the policies lapse, according to the Indictment. The defendants and their co-conspirators also returned verification calls to AIL purporting to be the applicants on the fraudulent applications from telephones set up exclusively for the fraudulent scheme. In an effort to avoid detection, the defendants listed addresses of gas stations and apartment complexes on many of the fraudulent applications, and fabricated the names of the beneficiaries of the policies.
Halali, 29, of San Jose; Magat, 32, of Hayward; Jilge, 30, San Jose; Gagarin, 29, of San Jose; and Soundara, 33, of Oakland, are charged with conspiracy to commit wire fraud in violation of Title 18, United States Code, Section 1349; substantive wire fraud counts, in violation of Title 18, United States, Code, Section 1343; and aggravated identity theft, in violation of Title 18, United States Code, § 1028A(a)(1). Halali, Magat, and Jilge are also charged with money laundering, in violation of Title 18, United States Code, § 1957.
The maximum statutory penalties for conspiracy to commit wire fraud and for wire fraud charges in violation of 18 U.S.C. §§ 1349 and 1343 are a prison term of 20 years, and a fine of $250,000 or twice the gross gain or loss from the offense, plus restitution. The maximum statutory penalty for aggravated identity theft in violation of 18 U.S.C. § 1028A is a mandatory prison sentence of 2 years. The maximum statutory penalties for money laundering in violation of 18 U.S.C. § 1957 is a prison term of 10 years, and a fine of $250,000 or twice the value of the criminally derived property.
All of the defendants appeared before Magistrate Judge Laurel Beeler for their initial appearances yesterday morning, and the case has been assigned to the Honorable Susan Illston, United States District Judge. The defendants are scheduled to have a follow-up appearance before Judge Beeler for ID of counsel and to finalize the defendants bail conditions tomorrow, Dec.19, 2014, at 9:30 a.m. All five defendants are also scheduled to appear before Judge Illston on Jan. 23, 2015, at 11:00 a.m.
Kim A. Berger is the Assistant U.S. Attorney who is prosecuting the case with the assistance of Bridget Kilkenney. This prosecution is the result of an investigation by the FBI, the IRS, Criminal Investigation Division, and the California Department of Insurance.
Please note that an indictment contains only allegations. As with all defendants, Behnam Halali, Ernesto Magat, Kraig Jilge, Karen Gagarin, and Alomkone Soundara, must be presumed innocent unless and until they are proven guilty.
Department of Justice
U.S. Attorney’s Office
Northern District of California
FOR IMMEDIATE RELEASE
Thursday, December 18, 2014
Five Defendants Charged In Fraudulent Life Insurance Policies Scheme
SAN FRANCISCO – Behnam Halali, Ernesto Magat, Kraig Jilge, Karen Gagarin, and Alomkone Soundara, a/k/a Alex Soundara, were charged in an indictment unsealed yesterday in federal court in connection with a scheme involving fraudulent life insurance policies while each was employed at the American Income Life Insurance Company (AIL), announced U.S. Attorney Melinda Haag, FBI Special Agent in Charge David J. Johnson, Internal Revenue Service, Criminal Investigation, Acting Special Agent in Charge Andrew Toth, and Commissioner Dave Jones of the California Department of Insurance.
According to the indictment, the defendants participated in a scheme involving the submission of applications for life insurance policies on behalf of people who did not know that a policy was applied for or issued in their name and/or did not want a life insurance policy. The defendants then shared the commissions and bonuses issued by AIL in connection with the fraudulent policies. The indictment alleges that the defendants paid recruiters to find people willing to take medical exams in exchange for approximately $100, and then took the personal information associated with those people and submitted applications for life insurance in their names, in many cases without the individuals’ knowledge. The defendants also allegedly paid people to participate in a fictitious survey of a medical exam company, and took the personal information associated with those people and submitted applications for life insurance, in many cases without the individuals’ knowledge. In some cases, the defendants allegedly created phony driver’s licenses so that they and their co-conspirators could take medical exams purporting to be the applicants. The defendants opened hundreds of bank accounts to fund the premiums on the fraudulent policies, and typically paid one to four months of premiums before letting the policies lapse, according to the Indictment. The defendants and their co-conspirators also returned verification calls to AIL purporting to be the applicants on the fraudulent applications from telephones set up exclusively for the fraudulent scheme. In an effort to avoid detection, the defendants listed addresses of gas stations and apartment complexes on many of the fraudulent applications, and fabricated the names of the beneficiaries of the policies.
Halali, 29, of San Jose; Magat, 32, of Hayward; Jilge, 30, San Jose; Gagarin, 29, of San Jose; and Soundara, 33, of Oakland, are charged with conspiracy to commit wire fraud in violation of Title 18, United States Code, Section 1349; substantive wire fraud counts, in violation of Title 18, United States, Code, Section 1343; and aggravated identity theft, in violation of Title 18, United States Code, § 1028A(a)(1). Halali, Magat, and Jilge are also charged with money laundering, in violation of Title 18, United States Code, § 1957.
The maximum statutory penalties for conspiracy to commit wire fraud and for wire fraud charges in violation of 18 U.S.C. §§ 1349 and 1343 are a prison term of 20 years, and a fine of $250,000 or twice the gross gain or loss from the offense, plus restitution. The maximum statutory penalty for aggravated identity theft in violation of 18 U.S.C. § 1028A is a mandatory prison sentence of 2 years. The maximum statutory penalties for money laundering in violation of 18 U.S.C. § 1957 is a prison term of 10 years, and a fine of $250,000 or twice the value of the criminally derived property.
All of the defendants appeared before Magistrate Judge Laurel Beeler for their initial appearances yesterday morning, and the case has been assigned to the Honorable Susan Illston, United States District Judge. The defendants are scheduled to have a follow-up appearance before Judge Beeler for ID of counsel and to finalize the defendants bail conditions tomorrow, Dec.19, 2014, at 9:30 a.m. All five defendants are also scheduled to appear before Judge Illston on Jan. 23, 2015, at 11:00 a.m.
Kim A. Berger is the Assistant U.S. Attorney who is prosecuting the case with the assistance of Bridget Kilkenney. This prosecution is the result of an investigation by the FBI, the IRS, Criminal Investigation Division, and the California Department of Insurance.
Please note that an indictment contains only allegations. As with all defendants, Behnam Halali, Ernesto Magat, Kraig Jilge, Karen Gagarin, and Alomkone Soundara, must be presumed innocent unless and until they are proven guilty.
SBA TOUTS BRANDS IT HELPED
FROM: U.S. SMALL BUSINESS ADMINISTRATION
This Holiday, SBA Celebrates the Brands We Helped Build
By Maria Contreras-Sweet, SBA Administrator
Published: December 19, 2014
Thirty-six years ago, a young computer programmer working out of his parents’ garage was looking for investments so he could create the world’s most user-friendly personal computer. He came upon a financier named John Hines, who managed an Illinois-based venture capital find licensed and supported by the U.S. Small Business Administration. Hines saw the potential and invested half a million dollars in the promising startup. Two years later, the young programmer took his company public, and the VC fund sold its stake for $44 million.
The programmer in question is the late Steve Jobs, and the fund that helped seed Apple in its infancy was part of the Small Business Investment Company (SBIC) program – the SBA’s investment arm.
While the SBA is perhaps best known for our loan programs, our SBIC program has helped build many hi-tech brands that will be familiar to holiday shoppers cruising down the electronics aisle this month. America Online, Intel, Compaq and Sun Microsystems all received investments from SBIC funds in their early days.
Beyond the I-Phone and the long shadow cast by the world’s most valuable company, this year’s gift-giving season includes many SBIC investments in starring roles. Parents helping their little ones customize their own stuffed animal at a Build-a-Bear store are shopping at a business seeded by an SBIC fund; same for those lucky souls who will awaken to a Tesla in their driveway on Christmas Day. If you’re a last-minute shopper mailing a present to a loved one through Fed Ex, you’re contributing to the legacy of the SBIC that helped build the world’s largest shipping company.
If you plan to stock up on holiday desserts at Costco or take the family to Outback Steakhouse or Quiznos for a meal – or if you burn off those calories later using Jenny Craig or Nutri-System – in each case you’ll be patronizing an SBIC success story.
Of course, our SBA loan programs have helped build some major brands, too. A former Maryland football player received a quarter-million dollar loan from SBA, and now his Under Armour products are being worn by athletes across the world. If your Mom – like mine – loves her Yankee Candles, she may be interested to know that it was an early SBA loan that helped deliver those wonderful scents to living rooms across America. And if your sister is angling for a new pair of shoes (Isn’t she always?), tell her that SBA helped launch Famous Footwear in Madison, Wis., in the 1960s.
For many families, Chevy Chase and the vacationing Griswalds will be an instrumental part of their holiday TV line-up this year. Here’s a fun fact: The Winnebago recreational vehicle came to life in the heartland in the 1960s, courtesy of two SBA loans.
And lest we forget the SBA’s flagship program to support small business innovators, the Small Business Innovation Research program provided early stage-funding to iRobot, creator of the Roomba vacuum cleaner. I suspect Roomba will be making some December 26th cameos as families try to clean up after the holiday stampede.
The SBA’s mission is to help small businesses grow. When companies that were once small become some of America’s biggest brands with our help, it gives all of us here at the agency a reason for holiday cheer.
Season’s greetings, everyone. I hope you and yours have a wonderful holiday. To paraphrase “Twas the Night Before Christmas…”
I heard Ben & Jerry say, as we took a big bite;
Thanks for the loan, SBA; you guys are all right.
This Holiday, SBA Celebrates the Brands We Helped Build
By Maria Contreras-Sweet, SBA Administrator
Published: December 19, 2014
Thirty-six years ago, a young computer programmer working out of his parents’ garage was looking for investments so he could create the world’s most user-friendly personal computer. He came upon a financier named John Hines, who managed an Illinois-based venture capital find licensed and supported by the U.S. Small Business Administration. Hines saw the potential and invested half a million dollars in the promising startup. Two years later, the young programmer took his company public, and the VC fund sold its stake for $44 million.
The programmer in question is the late Steve Jobs, and the fund that helped seed Apple in its infancy was part of the Small Business Investment Company (SBIC) program – the SBA’s investment arm.
While the SBA is perhaps best known for our loan programs, our SBIC program has helped build many hi-tech brands that will be familiar to holiday shoppers cruising down the electronics aisle this month. America Online, Intel, Compaq and Sun Microsystems all received investments from SBIC funds in their early days.
Beyond the I-Phone and the long shadow cast by the world’s most valuable company, this year’s gift-giving season includes many SBIC investments in starring roles. Parents helping their little ones customize their own stuffed animal at a Build-a-Bear store are shopping at a business seeded by an SBIC fund; same for those lucky souls who will awaken to a Tesla in their driveway on Christmas Day. If you’re a last-minute shopper mailing a present to a loved one through Fed Ex, you’re contributing to the legacy of the SBIC that helped build the world’s largest shipping company.
If you plan to stock up on holiday desserts at Costco or take the family to Outback Steakhouse or Quiznos for a meal – or if you burn off those calories later using Jenny Craig or Nutri-System – in each case you’ll be patronizing an SBIC success story.
Of course, our SBA loan programs have helped build some major brands, too. A former Maryland football player received a quarter-million dollar loan from SBA, and now his Under Armour products are being worn by athletes across the world. If your Mom – like mine – loves her Yankee Candles, she may be interested to know that it was an early SBA loan that helped deliver those wonderful scents to living rooms across America. And if your sister is angling for a new pair of shoes (Isn’t she always?), tell her that SBA helped launch Famous Footwear in Madison, Wis., in the 1960s.
For many families, Chevy Chase and the vacationing Griswalds will be an instrumental part of their holiday TV line-up this year. Here’s a fun fact: The Winnebago recreational vehicle came to life in the heartland in the 1960s, courtesy of two SBA loans.
And lest we forget the SBA’s flagship program to support small business innovators, the Small Business Innovation Research program provided early stage-funding to iRobot, creator of the Roomba vacuum cleaner. I suspect Roomba will be making some December 26th cameos as families try to clean up after the holiday stampede.
The SBA’s mission is to help small businesses grow. When companies that were once small become some of America’s biggest brands with our help, it gives all of us here at the agency a reason for holiday cheer.
Season’s greetings, everyone. I hope you and yours have a wonderful holiday. To paraphrase “Twas the Night Before Christmas…”
I heard Ben & Jerry say, as we took a big bite;
Thanks for the loan, SBA; you guys are all right.
SBA TOUTS 6 GOLDEN RULES FOR BUSINESS ON SOCIAL MEDIA
FROM: U.S. SMALL BUSINESS ADMINISTRATION
6 Golden Rules for Building Your Business with Social Media
By Caron_Beesley, Contributor
Published: December 17, 2014
Updated: December 17, 2014
Is your small business on social media? Is it working for you? Tried it but not convinced?
Social media is the top online activity in the U.S., according to Marketing TechBlog it also has a huge influence on consumer buying decisions. Forty-six percent of web users look towards social media when making a purchase, while 8 out of 10 SMBs report that they are using social media to drive growth.
Social media is clearly a proven channel for helping small business find and convert prospects – but it takes time and effort. Small businesses need to find ways to ways to connect, engage and drive actions.
If you’re looking for ideas to kick start or continue building your business using social media, here are six golden rules that can help.
Integrate your marketing channels
How do you get found on Twitter, Facebook or any social media platform? Well, it starts by prompting people with visual clues throughout your marketing channels, most notably your website. Ways to do this include:
Adding “Follow” buttons on your static website banners (see the top of this page)
Add social share buttons alongside content that you want to promote such as blogs or events (check out the ones on the top left of this blog)
Embed a feed on your site (take a look at the one on the SBA.gov homepage)
Don’t forget your emails, business cards, store signage and other channels
Plan your content
What should you post about? Well, what do your followers respond to best? This will vary greatly from business to business and takes time to gauge. But as a general rule people, follow brands on social media for the following top five reasons:
To get promotions and discounts
For the latest product information
Customer service (feedback, complaints, queries)
Entertaining content
The ability to offer feedback
This doesn’t mean you should spend your time using social media for promotions, instead strive for balance. Try to apply an 80:20 rule – 80 percent of your posts should focus on driving interactions while 20 percent of your posts can incorporate direct offers.
One of the easiest ways to do this is to scope out the week in advance, for example:
Mondays – Offer an exclusive promotion that’s only available to your social media followers and is redeemable with a unique code.
Tuesdays – Give a behind-the-scenes look at your business or focus on your people
Wednesdays – Create a series of helpful tips (link back to your blog to expand on the details)
Thursdays – Focus on your customers. Whether it’s responding to questions or highlighting a positive review.
Fridays – Feature industry experts or news. Retweet content, share articles or pin images that are relevant to your business.
Use photos and videos and other rich media
A visual is worth a thousand words. Look for ways to integrate images and rich media content into your social media posts. Using rich media like YouTube videos, memes, photos, and infographics can double engagementDownload Adobe Reader to read this link content.
Engage your audience
If you are posting interesting content, engagement will follow naturally. However, there are a few things you can do to encourage these relationships – listen to fans, chime in when you think you can add something, respond to comments, open the doors to shared experiences/needs, offer exclusive content (offers, downloads, etc.), encourage fans to share photos and experiences and always communicate authentically. Think of social media as a form of conversation – it’s a two-way dialog. If you’re not prepared to listen to what is being said to you, about you, or with you, then you simply aren’t “being social.”
It takes time to figure out what works. For example, you might think about using polls and surveys to engage with followers, but if you are still growing your network, you might not get the right results – yet. So, keep trying new things until you find a sweet spot.
Treat social media as a customer service tool
Customer service is a very important aspect of social media. Be prepared to monitor and respond to questions and complaints, make a point of recording feedback and sharing it with whoever owns that aspect of your business. These blogs offer more advice on this topic:
How to Use Social Media to do a Better Job of Customer Service
7 Tips for Dealing with Criticism of Your Business on Social Media
Measure
Don’t forget to measure the impact of your social media efforts. Use third party apps or Facebook’s Insights tool to monitor click-through rates. Compare these across posts to see if there’s a trend as to the type of content that’s popular. Measure engagement by tracking how many likes and shares your posts get (measured by Facebook as “reach”). Use this data to inform and adjust your content strategy.
Related resources
8 Ways to Develop Online Content for Your Business – Even if You Hate to Write
6 Quick Ways to Use Social Media for Branding
How to Use Trending Topics for Your Content Marketing
Webinar: Social Media Marketing Made Simple
Webinar: How Social Media can Help Your Business Succeed
6 Golden Rules for Building Your Business with Social Media
By Caron_Beesley, Contributor
Published: December 17, 2014
Updated: December 17, 2014
Is your small business on social media? Is it working for you? Tried it but not convinced?
Social media is the top online activity in the U.S., according to Marketing TechBlog it also has a huge influence on consumer buying decisions. Forty-six percent of web users look towards social media when making a purchase, while 8 out of 10 SMBs report that they are using social media to drive growth.
Social media is clearly a proven channel for helping small business find and convert prospects – but it takes time and effort. Small businesses need to find ways to ways to connect, engage and drive actions.
If you’re looking for ideas to kick start or continue building your business using social media, here are six golden rules that can help.
Integrate your marketing channels
How do you get found on Twitter, Facebook or any social media platform? Well, it starts by prompting people with visual clues throughout your marketing channels, most notably your website. Ways to do this include:
Adding “Follow” buttons on your static website banners (see the top of this page)
Add social share buttons alongside content that you want to promote such as blogs or events (check out the ones on the top left of this blog)
Embed a feed on your site (take a look at the one on the SBA.gov homepage)
Don’t forget your emails, business cards, store signage and other channels
Plan your content
What should you post about? Well, what do your followers respond to best? This will vary greatly from business to business and takes time to gauge. But as a general rule people, follow brands on social media for the following top five reasons:
To get promotions and discounts
For the latest product information
Customer service (feedback, complaints, queries)
Entertaining content
The ability to offer feedback
This doesn’t mean you should spend your time using social media for promotions, instead strive for balance. Try to apply an 80:20 rule – 80 percent of your posts should focus on driving interactions while 20 percent of your posts can incorporate direct offers.
One of the easiest ways to do this is to scope out the week in advance, for example:
Mondays – Offer an exclusive promotion that’s only available to your social media followers and is redeemable with a unique code.
Tuesdays – Give a behind-the-scenes look at your business or focus on your people
Wednesdays – Create a series of helpful tips (link back to your blog to expand on the details)
Thursdays – Focus on your customers. Whether it’s responding to questions or highlighting a positive review.
Fridays – Feature industry experts or news. Retweet content, share articles or pin images that are relevant to your business.
Use photos and videos and other rich media
A visual is worth a thousand words. Look for ways to integrate images and rich media content into your social media posts. Using rich media like YouTube videos, memes, photos, and infographics can double engagementDownload Adobe Reader to read this link content.
Engage your audience
If you are posting interesting content, engagement will follow naturally. However, there are a few things you can do to encourage these relationships – listen to fans, chime in when you think you can add something, respond to comments, open the doors to shared experiences/needs, offer exclusive content (offers, downloads, etc.), encourage fans to share photos and experiences and always communicate authentically. Think of social media as a form of conversation – it’s a two-way dialog. If you’re not prepared to listen to what is being said to you, about you, or with you, then you simply aren’t “being social.”
It takes time to figure out what works. For example, you might think about using polls and surveys to engage with followers, but if you are still growing your network, you might not get the right results – yet. So, keep trying new things until you find a sweet spot.
Treat social media as a customer service tool
Customer service is a very important aspect of social media. Be prepared to monitor and respond to questions and complaints, make a point of recording feedback and sharing it with whoever owns that aspect of your business. These blogs offer more advice on this topic:
How to Use Social Media to do a Better Job of Customer Service
7 Tips for Dealing with Criticism of Your Business on Social Media
Measure
Don’t forget to measure the impact of your social media efforts. Use third party apps or Facebook’s Insights tool to monitor click-through rates. Compare these across posts to see if there’s a trend as to the type of content that’s popular. Measure engagement by tracking how many likes and shares your posts get (measured by Facebook as “reach”). Use this data to inform and adjust your content strategy.
Related resources
8 Ways to Develop Online Content for Your Business – Even if You Hate to Write
6 Quick Ways to Use Social Media for Branding
How to Use Trending Topics for Your Content Marketing
Webinar: Social Media Marketing Made Simple
Webinar: How Social Media can Help Your Business Succeed
OSHA FINDS CRUSHED SUPERMARKET WORKER'S DEATH PREVENTABLE
FROM: U.S. DEPARTMENT OF LABOR
News Release
OSHA News Release: [12/17/2014]
Contact Name: Ted Fitzgerald or Andre Bowser
Release Number: 14-2254-NEW
Death of Brooklyn, New York, supermarket worker preventable, OSHA finds
Citations for exit access, fall, chemical hazards to Moisha’s Kosher Discount Supermarket
NEW YORK — A 22-year-old employee of Moisha's Kosher Discount Supermarket Inc. in Brooklyn was fatally crushed between a cement wall and a forklift on June 10, 2014, as employees used an electrical pallet jack to push a broken forklift up a ramp to the supermarket's roof. While doing so, the forklift rolled back down the ramp, and then pinned the worker against the wall. An inspection by the U.S. Department of Labor's Occupational Safety and Health Administration on the same day as the fatality found that his death was preventable.
OSHA determined that the broken 8,600-pound forklift weighed twice the pallet jack's maximum capacity of 4,000 pounds; the defective forklift had not been removed from service, as required; and workers had not been trained to operate the forklift or the pallet jack safely.
"The pallet jack and forklift were not used and moved correctly, which resulted in a needless, avoidable loss of a worker's life," said Kay Gee, OSHA's area director for Brooklyn, Manhattan and Queens. "Tragically, Moisha's Kosher Discount Supermarket employees were not trained to use these machines safely and could not recognize their exposure to a deadly hazard."
OSHA's powered industrial truck standard requires that employers teach workers how to operate machines properly and ensure that they understand the training. The standard also prohibits pallet jacks and forklifts from lifting or moving objects heavier than their maximum lifting capacity.
OSHA's inspection identified nine serious violations of workplace safety standards in the supermarket's warehouse. These included blocked exit aisles and passageways; missing exit signs; misuse of portable ladders and a battery charger; lack of quick drenching eyewash for employees who worked with corrosive chemicals; and lack of a chemical hazard communication plan.
A serious violation occurs when there is substantial probability that death or serious physical harm could result from a hazard about which the employer knew or should have known.
"Nothing can bring this worker back to his loved ones. This employer must take immediate, effective steps to identify, minimize and eliminate hazardous conditions to avoid another senseless tragedy," said Robert Kulick, OSHA's regional administrator in New York.
Located at 315 Avenue M in Brooklyn, Moisha's Kosher Discount Supermarket faces $42,000 in fines. The company has 15 business days from receipt of its citations and proposed penalties to comply, meet with OSHA's area director, or contest the findings before the independent Occupational Safety and Health Review Commission.
News Release
OSHA News Release: [12/17/2014]
Contact Name: Ted Fitzgerald or Andre Bowser
Release Number: 14-2254-NEW
Death of Brooklyn, New York, supermarket worker preventable, OSHA finds
Citations for exit access, fall, chemical hazards to Moisha’s Kosher Discount Supermarket
NEW YORK — A 22-year-old employee of Moisha's Kosher Discount Supermarket Inc. in Brooklyn was fatally crushed between a cement wall and a forklift on June 10, 2014, as employees used an electrical pallet jack to push a broken forklift up a ramp to the supermarket's roof. While doing so, the forklift rolled back down the ramp, and then pinned the worker against the wall. An inspection by the U.S. Department of Labor's Occupational Safety and Health Administration on the same day as the fatality found that his death was preventable.
OSHA determined that the broken 8,600-pound forklift weighed twice the pallet jack's maximum capacity of 4,000 pounds; the defective forklift had not been removed from service, as required; and workers had not been trained to operate the forklift or the pallet jack safely.
"The pallet jack and forklift were not used and moved correctly, which resulted in a needless, avoidable loss of a worker's life," said Kay Gee, OSHA's area director for Brooklyn, Manhattan and Queens. "Tragically, Moisha's Kosher Discount Supermarket employees were not trained to use these machines safely and could not recognize their exposure to a deadly hazard."
OSHA's powered industrial truck standard requires that employers teach workers how to operate machines properly and ensure that they understand the training. The standard also prohibits pallet jacks and forklifts from lifting or moving objects heavier than their maximum lifting capacity.
OSHA's inspection identified nine serious violations of workplace safety standards in the supermarket's warehouse. These included blocked exit aisles and passageways; missing exit signs; misuse of portable ladders and a battery charger; lack of quick drenching eyewash for employees who worked with corrosive chemicals; and lack of a chemical hazard communication plan.
A serious violation occurs when there is substantial probability that death or serious physical harm could result from a hazard about which the employer knew or should have known.
"Nothing can bring this worker back to his loved ones. This employer must take immediate, effective steps to identify, minimize and eliminate hazardous conditions to avoid another senseless tragedy," said Robert Kulick, OSHA's regional administrator in New York.
Located at 315 Avenue M in Brooklyn, Moisha's Kosher Discount Supermarket faces $42,000 in fines. The company has 15 business days from receipt of its citations and proposed penalties to comply, meet with OSHA's area director, or contest the findings before the independent Occupational Safety and Health Review Commission.
Monday, December 22, 2014
DOD NEWS: AIRSTRIKES CONTINUE IN SYRIA, IRAQ
Right: 141219-N-DJ750-043 INDIAN OCEAN (Dec. 19, 2014) The guided-missile destroyer USS Gridley (DDG 101) transits the Indian Ocean. Gridley is deployed in the U.S. 5th Fleet area of responsibility supporting Operation Inherent Resolve, strike operations in Iraq and Syria as directed, maritime security operations, and theater security cooperation efforts in the region. (U.S. Navy photo by Mass Communication Specialist 3rd Class Bryan Jackson/Released).
Military Airstrikes Continue Against ISIL in Syria and Iraq
DoD News, Defense Media Activity
SOUTHWEST ASIA , Dec. 22, 2014 – U.S. and partner nation military forces continued to attack Islamic State of Iraq and the Levant terrorists in Syria Dec. 22 using fighter and bomber aircraft to conduct 12 airstrikes.
Separately, U.S. and partner nation military forces conducted 10 airstrikes in Iraq Dec. 22 using fighter, bomber, and attack aircraft against the ISIL terrorists. These engagements were in support of the 7th Iraqi Army, local police and tribal fighters engaged in fighting with ISIL forces in the vicinity of Dulab.
The following is a summary of those strikes:
Syria
• Near Kobani, six airstrikes destroyed six ISIL fighting positions and struck four ISIL fighting positions and an ISIL tactical unit.
• Near Aleppo, three airstrikes destroyed artillery equipment and struck 10 ISIL buildings.
• Near Al Hasakah, two airstrikes destroyed an ISIL tactical vehicle, two ISIL trucks, an ISIL building, and two ISIL storage containers.
• Near Ar Raqqah, an airstrike destroyed an ISIL checkpoint complex.
Iraq
• Near Sinjar, three airstrikes destroyed three ISIL tactical vehicles, three ISIL trucks, five ISIL buildings and struck two large ISIL units and an ISIL tactical unit.
• Near Al Asad, two airstrikes destroyed an ISIL tactical vehicle and struck two ISIL tactical units.
• Near Tal Afar, two airstrikes destroyed an ISIL checkpoint.
• Near Ramadi, an airstrike destroyed two ISIL vehicles, an ISIL building and struck an ISIL tactical unit.
• Near Mosul, an airstrike destroyed an ISIL vehicle.
• Near Fallujah, an airstrike destroyed two ISIL buildings and struck a weapons factory complex.
All aircraft returned to base safely. Airstrike assessments are based on initial reports.
The strikes were conducted as part of Operation Inherent Resolve, the operation to eliminate the ISIL terrorist group and the threat they pose to Iraq, the region and the wider international community. The destruction of ISIL targets in Syria and Iraq further limits the terrorist group's ability to project terror and conduct operations.
Coalition nations conducting airstrikes in Iraq include the U.S., Australia, Belgium, Canada, Denmark, France, Netherlands and the United Kingdom. Coalition Nations conducting airstrikes in Syria include the U.S., Bahrain,
Jordan, Saudi Arabia, and the United Arab Emirates.
FRENCH COMPANY PLEADS GUILTY, AGREES TO PAY OVER $772 MILLION TO RESOLVE BRIBERY CHARGES
FROM: U.S. JUSTICE DEPARTMENT
Monday, December 22, 2014
Alstom Pleads Guilty and Agrees to Pay $772 Million Criminal Penalty to Resolve Foreign Bribery Charges
Alstom S.A. (Alstom), a French power and transportation company, pleaded guilty today and agreed to pay a $772,290,000 fine to resolve charges related to a widespread scheme involving tens of millions of dollars in bribes in countries around the world, including Indonesia, Saudi Arabia, Egypt and the Bahamas.
Deputy Attorney General James M. Cole, Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division, First Assistant U.S. Attorney Michael J. Gustafson of the District of Connecticut and FBI Executive Assistant Director Robert Anderson Jr. made the announcement.
“Alstom’s corruption scheme was sustained over more than a decade and across several continents,” said Deputy Attorney General Cole. “It was astounding in its breadth, its brazenness and its worldwide consequences. And it is both my expectation – and my intention – that the comprehensive resolution we are announcing today will send an unmistakable message to other companies around the world: that this Department of Justice will be relentless in rooting out and punishing corruption to the fullest extent of the law, no matter how sweeping its scale or how daunting its prosecution.”
“This case is emblematic of how the Department of Justice will investigate and prosecute FCPA cases – and other corporate crimes,” said Assistant Attorney General Caldwell. “We encourage companies to maintain robust compliance programs, to voluntarily disclose and eradicate misconduct when it is detected, and to cooperate in the government’s investigation. But we will not wait for companies to act responsibly. With cooperation or without it, the department will identify criminal activity at corporations and investigate the conduct ourselves, using all of our resources, employing every law enforcement tool, and considering all possible actions, including charges against both corporations and individuals.”
“Today’s historic resolution is an important reminder that our moral and legal mandate to stamp out corruption does not stop at any border, whether city, state or national,” said First Assistant U.S. Attorney Gustafson. “A significant part of this illicit work was unfortunately carried out from Alstom Power’s offices in Windsor, Connecticut. I am hopeful that this resolution, and in particular the deferred prosecution agreement with Alstom Power, will provide the company an opportunity to reshape its culture and restore its place as a respected corporate citizen.”
“This investigation spanned years and crossed continents, as agents from the FBI Washington and New Haven field offices conducted interviews and collected evidence in every corner of the globe,” said FBI Executive Assistant Director Anderson. “The record dollar amount of the fine is a clear deterrent to companies who would engage in foreign bribery, but an even better deterrent is that we are sending executives who commit these crimes to prison.”
Alstom pleaded guilty to a two-count criminal information filed today in the U.S. District Court for the District of Connecticut, charging the company with violating the Foreign Corrupt Practices Act (FCPA) by falsifying its books and records and failing to implement adequate internal controls. Alstom admitted its criminal conduct and agreed to pay a criminal penalty of $772,290,000. U.S. District Judge Janet B. Arterton of the District of Connecticut scheduled a sentencing hearing for June 23, 2015 at 3pm.
In addition, Alstom Network Schweiz AG, formerly Alstom Prom (Alstom Prom), Alstom’s Swiss subsidiary, pleaded guilty to a criminal information charging the company with conspiracy to violate the anti-bribery provisions of the FCPA. Alstom Power Inc. (Alstom Power) and Alstom Grid Inc. (Alstom Grid), two U.S. subsidiaries, both entered into deferred prosecution agreements, admitting that they conspired to violate the anti-bribery provisions of the FCPA. Alstom Power is headquartered in Windsor, Connecticut, and Alstom Grid, formerly Alstom T&D, was headquartered in New Jersey.
According to the companies’ admissions, Alstom, Alstom Prom, Alstom Power and Alstom Grid, through various executives and employees, paid bribes to government officials and falsified books and records in connection with power, grid and transportation projects for state-owned entities around the world, including in Indonesia, Egypt, Saudi Arabia, the Bahamas and Taiwan. In Indonesia, for example, Alstom, Alstom Prom, and Alstom Power paid bribes to government officials – including a high-ranking member of the Indonesian Parliament and high-ranking members of Perusahaan Listrik Negara, the state-owned electricity company in Indonesia – in exchange for assistance in securing several contracts to provide power-related services valued at approximately $375 million. In total, Alstom paid more than $75 million to secure $4 billion in projects around the world, with a profit to the company of approximately $300 million.
Alstom and its subsidiaries also attempted to conceal the bribery scheme by retaining consultants purportedly to provide consulting services on behalf of the companies, but who actually served as conduits for corrupt payments to the government officials. Internal Alstom documents refer to some of the consultants in code, including “Mr. Geneva,” “Mr. Paris,” “London,” “Quiet Man” and “Old Friend.”
The plea agreement cites many factors considered by the department in reaching the appropriate resolution, including: Alstom’s failure to voluntarily disclose the misconduct even though it was aware of related misconduct at a U.S. subsidiary that previously resolved corruption charges with the department in connection with a power project in Italy; Alstom’s refusal to fully cooperate with the department’s investigation for several years; the breadth of the companies’ misconduct, which spanned many years, occurred in countries around the globe and in several business lines, and involved sophisticated schemes to bribe high-level government officials; Alstom’s lack of an effective compliance and ethics program at the time of the conduct; and Alstom’s prior criminal misconduct, including conduct that led to resolutions with various other governments and the World Bank.
After the department publicly charged several Alstom executives, however, Alstom began providing thorough cooperation, including assisting the department’s prosecution of other companies and individuals.
To date, the department has announced charges against five individuals, including four corporate executives of Alstom and its subsidiaries, for alleged corrupt conduct involving Alstom. Frederic Pierucci, Alstom’s former vice president of global boiler sales, pleaded guilty on July 29, 2013, to conspiring to violate the FCPA and a charge of violating the FCPA for his role in the Indonesia bribery scheme. David Rothschild, Alstom Power’s former vice president of regional sales, pleaded guilty on Nov. 2, 2012, to conspiracy to violate the FCPA. William Pomponi, Alstom Power’s former vice president of regional sales, pleaded guilty on July 17, 2014, to conspiracy to violate the FCPA. Lawrence Hoskins, Alstom’s former senior vice president for the Asia region, was charged in a second superseding indictment on July 30, 2013, and is pending trial in the District of Connecticut in June 2015. The charges against Hoskins are merely allegations, and he is presumed innocent unless and until proven guilty. The high-ranking member of Indonesian Parliament was also convicted in Indonesia of accepting bribes from Alstom, and is currently serving a three-year term of imprisonment.
In connection with a corrupt scheme in Egypt, Asem Elgawhary, the general manager of an entity working on behalf of the Egyptian Electricity Holding Company, a state-owned electricity company, pleaded guilty on Dec. 4, 2014, in federal court in the District of Maryland to mail fraud, conspiring to launder money, and tax fraud for accepting kickbacks from Alstom and other companies. In his plea agreement, Elgawhary agreed to serve 42 months in prison and forfeit approximately $5.2 million in proceeds.
This case is being investigated by the FBI’s Washington Field Office, with assistance from the FBI’s Meriden, Connecticut Resident Agency, and the FBI’s Newark and Baltimore Divisions. The department appreciates the significant cooperation provided by its law enforcement colleagues in Indonesia at the Komisi Pemberantasan Korupsi (Corruption Eradication Commission), the Office of the Attorney General in Switzerland, the Serious Fraud Office in the United Kingdom, as well as authorities in Germany, Italy, Singapore, Saudi Arabia, Cyprus and Taiwan.
The case is being prosecuted by Assistant Chief Daniel S. Kahn of the Criminal Division’s Fraud Section and Assistant U.S. Attorney David E. Novick of the District of Connecticut, together with Assistant U.S. Attorney Zach Intrater of the District of New Jersey on the investigation of Alstom Grid and Assistant U.S. Attorney David I. Salem of the District of Maryland on the investigation of Asem Elgawhary. The Criminal Division’s Office of International Affairs also provided substantial assistance.
Monday, December 22, 2014
Alstom Pleads Guilty and Agrees to Pay $772 Million Criminal Penalty to Resolve Foreign Bribery Charges
Alstom S.A. (Alstom), a French power and transportation company, pleaded guilty today and agreed to pay a $772,290,000 fine to resolve charges related to a widespread scheme involving tens of millions of dollars in bribes in countries around the world, including Indonesia, Saudi Arabia, Egypt and the Bahamas.
Deputy Attorney General James M. Cole, Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division, First Assistant U.S. Attorney Michael J. Gustafson of the District of Connecticut and FBI Executive Assistant Director Robert Anderson Jr. made the announcement.
“Alstom’s corruption scheme was sustained over more than a decade and across several continents,” said Deputy Attorney General Cole. “It was astounding in its breadth, its brazenness and its worldwide consequences. And it is both my expectation – and my intention – that the comprehensive resolution we are announcing today will send an unmistakable message to other companies around the world: that this Department of Justice will be relentless in rooting out and punishing corruption to the fullest extent of the law, no matter how sweeping its scale or how daunting its prosecution.”
“This case is emblematic of how the Department of Justice will investigate and prosecute FCPA cases – and other corporate crimes,” said Assistant Attorney General Caldwell. “We encourage companies to maintain robust compliance programs, to voluntarily disclose and eradicate misconduct when it is detected, and to cooperate in the government’s investigation. But we will not wait for companies to act responsibly. With cooperation or without it, the department will identify criminal activity at corporations and investigate the conduct ourselves, using all of our resources, employing every law enforcement tool, and considering all possible actions, including charges against both corporations and individuals.”
“Today’s historic resolution is an important reminder that our moral and legal mandate to stamp out corruption does not stop at any border, whether city, state or national,” said First Assistant U.S. Attorney Gustafson. “A significant part of this illicit work was unfortunately carried out from Alstom Power’s offices in Windsor, Connecticut. I am hopeful that this resolution, and in particular the deferred prosecution agreement with Alstom Power, will provide the company an opportunity to reshape its culture and restore its place as a respected corporate citizen.”
“This investigation spanned years and crossed continents, as agents from the FBI Washington and New Haven field offices conducted interviews and collected evidence in every corner of the globe,” said FBI Executive Assistant Director Anderson. “The record dollar amount of the fine is a clear deterrent to companies who would engage in foreign bribery, but an even better deterrent is that we are sending executives who commit these crimes to prison.”
Alstom pleaded guilty to a two-count criminal information filed today in the U.S. District Court for the District of Connecticut, charging the company with violating the Foreign Corrupt Practices Act (FCPA) by falsifying its books and records and failing to implement adequate internal controls. Alstom admitted its criminal conduct and agreed to pay a criminal penalty of $772,290,000. U.S. District Judge Janet B. Arterton of the District of Connecticut scheduled a sentencing hearing for June 23, 2015 at 3pm.
In addition, Alstom Network Schweiz AG, formerly Alstom Prom (Alstom Prom), Alstom’s Swiss subsidiary, pleaded guilty to a criminal information charging the company with conspiracy to violate the anti-bribery provisions of the FCPA. Alstom Power Inc. (Alstom Power) and Alstom Grid Inc. (Alstom Grid), two U.S. subsidiaries, both entered into deferred prosecution agreements, admitting that they conspired to violate the anti-bribery provisions of the FCPA. Alstom Power is headquartered in Windsor, Connecticut, and Alstom Grid, formerly Alstom T&D, was headquartered in New Jersey.
According to the companies’ admissions, Alstom, Alstom Prom, Alstom Power and Alstom Grid, through various executives and employees, paid bribes to government officials and falsified books and records in connection with power, grid and transportation projects for state-owned entities around the world, including in Indonesia, Egypt, Saudi Arabia, the Bahamas and Taiwan. In Indonesia, for example, Alstom, Alstom Prom, and Alstom Power paid bribes to government officials – including a high-ranking member of the Indonesian Parliament and high-ranking members of Perusahaan Listrik Negara, the state-owned electricity company in Indonesia – in exchange for assistance in securing several contracts to provide power-related services valued at approximately $375 million. In total, Alstom paid more than $75 million to secure $4 billion in projects around the world, with a profit to the company of approximately $300 million.
Alstom and its subsidiaries also attempted to conceal the bribery scheme by retaining consultants purportedly to provide consulting services on behalf of the companies, but who actually served as conduits for corrupt payments to the government officials. Internal Alstom documents refer to some of the consultants in code, including “Mr. Geneva,” “Mr. Paris,” “London,” “Quiet Man” and “Old Friend.”
The plea agreement cites many factors considered by the department in reaching the appropriate resolution, including: Alstom’s failure to voluntarily disclose the misconduct even though it was aware of related misconduct at a U.S. subsidiary that previously resolved corruption charges with the department in connection with a power project in Italy; Alstom’s refusal to fully cooperate with the department’s investigation for several years; the breadth of the companies’ misconduct, which spanned many years, occurred in countries around the globe and in several business lines, and involved sophisticated schemes to bribe high-level government officials; Alstom’s lack of an effective compliance and ethics program at the time of the conduct; and Alstom’s prior criminal misconduct, including conduct that led to resolutions with various other governments and the World Bank.
After the department publicly charged several Alstom executives, however, Alstom began providing thorough cooperation, including assisting the department’s prosecution of other companies and individuals.
To date, the department has announced charges against five individuals, including four corporate executives of Alstom and its subsidiaries, for alleged corrupt conduct involving Alstom. Frederic Pierucci, Alstom’s former vice president of global boiler sales, pleaded guilty on July 29, 2013, to conspiring to violate the FCPA and a charge of violating the FCPA for his role in the Indonesia bribery scheme. David Rothschild, Alstom Power’s former vice president of regional sales, pleaded guilty on Nov. 2, 2012, to conspiracy to violate the FCPA. William Pomponi, Alstom Power’s former vice president of regional sales, pleaded guilty on July 17, 2014, to conspiracy to violate the FCPA. Lawrence Hoskins, Alstom’s former senior vice president for the Asia region, was charged in a second superseding indictment on July 30, 2013, and is pending trial in the District of Connecticut in June 2015. The charges against Hoskins are merely allegations, and he is presumed innocent unless and until proven guilty. The high-ranking member of Indonesian Parliament was also convicted in Indonesia of accepting bribes from Alstom, and is currently serving a three-year term of imprisonment.
In connection with a corrupt scheme in Egypt, Asem Elgawhary, the general manager of an entity working on behalf of the Egyptian Electricity Holding Company, a state-owned electricity company, pleaded guilty on Dec. 4, 2014, in federal court in the District of Maryland to mail fraud, conspiring to launder money, and tax fraud for accepting kickbacks from Alstom and other companies. In his plea agreement, Elgawhary agreed to serve 42 months in prison and forfeit approximately $5.2 million in proceeds.
This case is being investigated by the FBI’s Washington Field Office, with assistance from the FBI’s Meriden, Connecticut Resident Agency, and the FBI’s Newark and Baltimore Divisions. The department appreciates the significant cooperation provided by its law enforcement colleagues in Indonesia at the Komisi Pemberantasan Korupsi (Corruption Eradication Commission), the Office of the Attorney General in Switzerland, the Serious Fraud Office in the United Kingdom, as well as authorities in Germany, Italy, Singapore, Saudi Arabia, Cyprus and Taiwan.
The case is being prosecuted by Assistant Chief Daniel S. Kahn of the Criminal Division’s Fraud Section and Assistant U.S. Attorney David E. Novick of the District of Connecticut, together with Assistant U.S. Attorney Zach Intrater of the District of New Jersey on the investigation of Alstom Grid and Assistant U.S. Attorney David I. Salem of the District of Maryland on the investigation of Asem Elgawhary. The Criminal Division’s Office of International Affairs also provided substantial assistance.
WHITE HOUSE STATEMENT ON ELECTION IN TUNISIA
FROM: THE WHITE HOUSE PRESIDENTIAL
December 22, 2014
Statement by the Press Secretary on the Presidential Election in Tunisia
President Obama congratulates President-elect Beji Caid Essebsi on his victory and the people of Tunisia on the successful conclusion of the first presidential election under the new constitution, a vital step toward the completion of Tunisia’s momentous transition to democracy. The United States looks forward to working closely with President-elect Caid Essebsi and the new government as they work to uphold the ideals of the Tunisian revolution and to meet all Tunisians’ aspirations for security, economic opportunity, and dignity. The United States intends to continue to strengthen and expand our strategic partnership with the Tunisian people.
The strong commitment by Tunisia's leaders and the Tunisian people to inclusive political dialogue, consensus-building, and democratic values has been crucial to the success of the political transition and will be equally important during the next phase of Tunisia's history. This historic moment is an opportunity for the international community to reaffirm and deepen its commitment to Tunisia. The United States stands at the forefront of this effort.
December 22, 2014
Statement by the Press Secretary on the Presidential Election in Tunisia
President Obama congratulates President-elect Beji Caid Essebsi on his victory and the people of Tunisia on the successful conclusion of the first presidential election under the new constitution, a vital step toward the completion of Tunisia’s momentous transition to democracy. The United States looks forward to working closely with President-elect Caid Essebsi and the new government as they work to uphold the ideals of the Tunisian revolution and to meet all Tunisians’ aspirations for security, economic opportunity, and dignity. The United States intends to continue to strengthen and expand our strategic partnership with the Tunisian people.
The strong commitment by Tunisia's leaders and the Tunisian people to inclusive political dialogue, consensus-building, and democratic values has been crucial to the success of the political transition and will be equally important during the next phase of Tunisia's history. This historic moment is an opportunity for the international community to reaffirm and deepen its commitment to Tunisia. The United States stands at the forefront of this effort.
U.S. SENDS WARM WISHES TO JAPAN'S EMPEROR ON HIS BIRTHDAY
FROM: U.S. STATE DEPARTMENT
The Emperor of Japan's Birthday
Press Statement
John Kerry
Secretary of State
Washington, DC
December 22, 2014
On behalf of President Obama and the people of the United States, I would like to send warm wishes to His Imperial Majesty on his 81st birthday this December 23 and congratulate Japan on this national day of celebration.
As I have mentioned in my many meetings with Foreign Minister Kishida, and as President Obama reiterated when he spoke with Prime Minister Abe last week, the United States-Japan Alliance has long been the cornerstone of peace and security in the Asia-Pacific region.
Based on our shared values and interests, Japan and the United States have forged an effective global partnership. We are grateful for Japan’s efforts to strengthen democratic institutions, advance women’s empowerment, promote sustainable economic development, respond generously to global challenges, and reinforce the rule of law throughout the world. The United States looks forward to continued cooperation with Japan in the years ahead.
We wish all Japanese people around the world peace and prosperity over the coming year.
The Emperor of Japan's Birthday
Press Statement
John Kerry
Secretary of State
Washington, DC
December 22, 2014
On behalf of President Obama and the people of the United States, I would like to send warm wishes to His Imperial Majesty on his 81st birthday this December 23 and congratulate Japan on this national day of celebration.
As I have mentioned in my many meetings with Foreign Minister Kishida, and as President Obama reiterated when he spoke with Prime Minister Abe last week, the United States-Japan Alliance has long been the cornerstone of peace and security in the Asia-Pacific region.
Based on our shared values and interests, Japan and the United States have forged an effective global partnership. We are grateful for Japan’s efforts to strengthen democratic institutions, advance women’s empowerment, promote sustainable economic development, respond generously to global challenges, and reinforce the rule of law throughout the world. The United States looks forward to continued cooperation with Japan in the years ahead.
We wish all Japanese people around the world peace and prosperity over the coming year.
U.S. CONGRATULATES PEOPLE OF TUNISIA ON THEIR PRESIDENTIAL ELECTION
FROM: U.S. STATE DEPARTMENT
Tunisia's Presidential Election
Press Statement
John Kerry
Secretary of State
Washington, DC
December 22, 2014
On behalf of the government and people of the United States, I would like to congratulate President-elect Beji Caid Essebsi on his victory and the Tunisian people on the successful completion of their process to elect a new government under the constitution adopted last January. Tunisia has provided a shining example to the region and the world of what can be achieved through dedication to democracy, consensus, and an inclusive political process. I would also like to offer my congratulations to the Independent Election Commission, which successfully managed a very complex and challenging process this year to democratically elect a parliament and president.
Tunisia’s achievements this year lay the groundwork for a more stable, prosperous, and democratic future for the country. I look forward to working with President-elect Caid Essebsi and Tunisia’s new parliament and government to strengthen and expand our countries’ enduring friendship and strategic partnership. The United States will continue to support Tunisia as it joins the ranks of the world’s democracies, and we call on other members of the international community to do the same.
Tunisia's Presidential Election
Press Statement
John Kerry
Secretary of State
Washington, DC
December 22, 2014
On behalf of the government and people of the United States, I would like to congratulate President-elect Beji Caid Essebsi on his victory and the Tunisian people on the successful completion of their process to elect a new government under the constitution adopted last January. Tunisia has provided a shining example to the region and the world of what can be achieved through dedication to democracy, consensus, and an inclusive political process. I would also like to offer my congratulations to the Independent Election Commission, which successfully managed a very complex and challenging process this year to democratically elect a parliament and president.
Tunisia’s achievements this year lay the groundwork for a more stable, prosperous, and democratic future for the country. I look forward to working with President-elect Caid Essebsi and Tunisia’s new parliament and government to strengthen and expand our countries’ enduring friendship and strategic partnership. The United States will continue to support Tunisia as it joins the ranks of the world’s democracies, and we call on other members of the international community to do the same.
SEC CHARGES FIRM, IT'S PRESIDENT & 2 SALES ASSOCIATES IN FRAUDULENT IPO OFFERINGS SCHEME TARGETING SENIORS
FROM: U.S. JUSTICE DEPARTMENT
The Securities and Exchange Commission charged a Staten Island, N.Y.-based firm, its former president, and two sales representatives involved in a fraudulent boiler room scheme targeting seniors to invest in speculative start-up companies.
The SEC alleges that Dwayne Malloy, Chris Damon, and Theirry Ruffin treated vulnerable older investors as their personal ATM machines. They cold-called names from a list they maintained at Premier Links Inc. and used high-pressure sales tactics to convince seniors to invest in companies purportedly on the brink of conducting initial public offerings (IPOs). They never disclosed to the investors that only a small fraction of the money would be transmitted to the promoted companies, and Premier Links diverted investor funds to other entities controlled by the sales representatives or other associates.
According to the SEC’s complaint filed in U.S. District Court for the Eastern District of New York, Premier Links has never been registered with the SEC as a broker-dealer as required under the federal securities laws to conduct this type of business with investors. Premier Links, Malloy, Damon, and Ruffin fraudulently obtained at least $9 million from more than 300 investors across the country by building a relationship of purported trust and confidence with them. In one particularly egregious example, Damon and Malloy spent months earning the trust of an elderly veteran in order to defraud him of $300,000. In many instances, investors were provided with misleading account statements showing the shares they purportedly purchased as being held for safekeeping in their Premier Links accounts while awaiting the promised IPOs. Yet transfer agent records for the relevant companies indicate that shares were never purchased for these investors. Investor money was simply stolen instead.
“Premier Links was a boiler room operated by unscrupulous schemers who made their living by cold-calling seniors and inducing them to buy worthless stock as they stole their money outright,” said Andrew M. Calamari, Director of the SEC’s New York Regional Office.
In a parallel action, the U.S. Attorney’s Office for the Eastern District of New York today filed criminal charges.
The SEC’s complaint charges Premier Links, Malloy (who was company president from 2007 to 2012), Damon, and Ruffin with violating the antifraud provisions of the Securities Act of 1933 and the Securities Exchange Act of 1934 as well as the broker-dealer registration provisions of the Exchange Act. They also are charged with selling securities without a registration statement filed with the SEC. The complaint seeks disgorgement of ill-gotten gains and financial penalties among other remedies. The complaint also names several relief defendants for the purposes of recovering money from the scheme in their possession.
The SEC’s investigation was conducted by Joshua Newville, Peter Pizzani, Thomas P. Smith Jr., and Michael Osnato of the SEC’s New York Regional Office. The case was supervised by Amelia A. Cottrell, and the litigation will be led by Todd Brody. The SEC appreciates the assistance of the U.S. Attorney’s Office for the Eastern District of New York and the Federal Bureau of Investigation.
The Securities and Exchange Commission charged a Staten Island, N.Y.-based firm, its former president, and two sales representatives involved in a fraudulent boiler room scheme targeting seniors to invest in speculative start-up companies.
The SEC alleges that Dwayne Malloy, Chris Damon, and Theirry Ruffin treated vulnerable older investors as their personal ATM machines. They cold-called names from a list they maintained at Premier Links Inc. and used high-pressure sales tactics to convince seniors to invest in companies purportedly on the brink of conducting initial public offerings (IPOs). They never disclosed to the investors that only a small fraction of the money would be transmitted to the promoted companies, and Premier Links diverted investor funds to other entities controlled by the sales representatives or other associates.
According to the SEC’s complaint filed in U.S. District Court for the Eastern District of New York, Premier Links has never been registered with the SEC as a broker-dealer as required under the federal securities laws to conduct this type of business with investors. Premier Links, Malloy, Damon, and Ruffin fraudulently obtained at least $9 million from more than 300 investors across the country by building a relationship of purported trust and confidence with them. In one particularly egregious example, Damon and Malloy spent months earning the trust of an elderly veteran in order to defraud him of $300,000. In many instances, investors were provided with misleading account statements showing the shares they purportedly purchased as being held for safekeeping in their Premier Links accounts while awaiting the promised IPOs. Yet transfer agent records for the relevant companies indicate that shares were never purchased for these investors. Investor money was simply stolen instead.
“Premier Links was a boiler room operated by unscrupulous schemers who made their living by cold-calling seniors and inducing them to buy worthless stock as they stole their money outright,” said Andrew M. Calamari, Director of the SEC’s New York Regional Office.
In a parallel action, the U.S. Attorney’s Office for the Eastern District of New York today filed criminal charges.
The SEC’s complaint charges Premier Links, Malloy (who was company president from 2007 to 2012), Damon, and Ruffin with violating the antifraud provisions of the Securities Act of 1933 and the Securities Exchange Act of 1934 as well as the broker-dealer registration provisions of the Exchange Act. They also are charged with selling securities without a registration statement filed with the SEC. The complaint seeks disgorgement of ill-gotten gains and financial penalties among other remedies. The complaint also names several relief defendants for the purposes of recovering money from the scheme in their possession.
The SEC’s investigation was conducted by Joshua Newville, Peter Pizzani, Thomas P. Smith Jr., and Michael Osnato of the SEC’s New York Regional Office. The case was supervised by Amelia A. Cottrell, and the litigation will be led by Todd Brody. The SEC appreciates the assistance of the U.S. Attorney’s Office for the Eastern District of New York and the Federal Bureau of Investigation.
LYNPARZA GETS FDA APPROVAL TO TREAT OVARIAN CANCER
FROM: U.S. FOOD AND DRUG ADMINISTRATION
FDA approves Lynparza to treat advanced ovarian cancer
First LDT companion diagnostic test also approved to identify appropriate patients
For Immediate Release
December 19, 2014
The U.S. Food and Drug Administration today granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.
Ovarian cancer forms in the ovary, one of a pair of female reproductive glands where ova, or eggs, are formed. The National Cancer Institute estimates that 21,980 American women will be diagnosed with and 14,270 will die from ovarian cancer in 2014.
Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that blocks enzymes involved in repairing damaged DNA. It is intended for women with heavily pretreated ovarian cancer that is associated with defective BRCA genes.
“Today’s approval constitutes the first of a new class of drugs for treating ovarian cancer,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Lynparza is approved for patients with specific abnormalities in the BRCA gene and is an example of how a greater understanding of the underlying mechanisms of disease can lead to targeted, more personalized treatment.
The FDA approved Lynparza with a genetic test called BRACAnalysis CDx, a companion diagnostic that will detect the presence of mutations in the BRCA genes (gBRCAm) in blood samples from patients with ovarian cancer. The BRCA genes are involved with repairing damaged DNA and normally work to suppress tumor growth. Women with mutations resulting in defective BRCA genes are more likely to get ovarian cancer, and it is estimated that 10 to 15 percent of all ovarian cancer is associated with these hereditary BRCA mutations.
The FDA evaluated the BRACAnalysis CDx’s safety and efficacy under the agency’s premarket approval pathway used for high-risk medical devices. Until now, the manufacturer, a clinical laboratory, had been marketing this test, although not specifically for use as a companion diagnostic, without FDA approval as a laboratory developed test (LDT), which is a test that is designed, manufactured and used in a single laboratory. The new test is approved as a companion diagnostic, specifically to identify patients with advanced ovarian cancer who may be candidates for treatment with Lynparza.
“The approval of safe and effective companion diagnostic tests and drugs continue to be important developments in oncology,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “We are very excited that the BRACAnalysis CDx is the FDA’s first approval of an LDT under a premarket approval application and is the first approval of an LDT companion diagnostic. The use of companion diagnostics helps bring to market safe and effective treatments specific to a patient’s needs.”
The FDA’s approval of the BRACAnalysis CDx is based on data from the clinical study used to support approval of Lynparza. Blood samples from clinical trial participants were tested to validate the test’s use for detecting BRCAmutations in this population.
Lynparza’s efficacy was examined in a study where 137 participants with gBRCAm-associated ovarian cancer received the drug. The study was designed to measure objective response rate (ORR), or the percentage of participants who experienced partial shrinkage or complete disappearance of the tumor. Results showed 34 percent of participants experienced ORR for an average of 7.9 months.
Common side effects of Lynparza included nausea, fatigue, vomiting, diarrhea, distorted taste (dysgeusia), indigestion (dyspepsia), headache, decreased appetite, common cold-like symptoms (nasopharyngitis), cough, joint paint (arthralgia), musculoskeletal pain, muscle pain (myalgia), back pain, rash (dermatitis) and abdominal pain. Serious side effects included the development of myelodysplastic syndrome, a condition where the bone marrow is unable to produce enough functioning blood cells; acute myeloid leukemia, a bone marrow cancer; and lung inflammation.
The most common laboratory abnormalities were increased creatinine, increased average volume of red blood cells (mean corpuscular volume elevation), decreased red blood cell count (hemoglobin), decreased white blood cell count (lymphocytes and neutrophils) and decreased platelet levels.
In June, Lynparza was reviewed by the FDA’s Oncologic Drugs Advisory Committee for potential use as maintenance therapy (treatment given to keep cancer from returning). The committee advised the agency in a vote of 11 to 2 that the data did not support Lynparza’s accelerated approval for this use. After the meeting, the company submitted additional information supporting Lynparza’s use for a different use: in patients with gBRCAm-associated ovarian cancer who have received three or more chemotherapy treatments.
The FDA is approving Lynparza under the agency’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials. Lynparza’s application was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and, if approved, would offer significant improvement compared to marketed products.
BRACAnalysis CDx’s application was reviewed under the FDA’s priority review program for devices, which provides for priority review of devices that meet certain criteria, including that the devices are intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and, if approved, would offer significant, clinically meaningful advantages compared to marketed products.
Lynparza is marketed by AstraZeneca Pharmaceuticals, based in Wilmington, Delaware. BRACAnalysis CDx is manufactured by and performed at Salt Lake City, Utah-based Myriad Genetic Laboratories, Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
FDA approves Lynparza to treat advanced ovarian cancer
First LDT companion diagnostic test also approved to identify appropriate patients
For Immediate Release
December 19, 2014
The U.S. Food and Drug Administration today granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.
Ovarian cancer forms in the ovary, one of a pair of female reproductive glands where ova, or eggs, are formed. The National Cancer Institute estimates that 21,980 American women will be diagnosed with and 14,270 will die from ovarian cancer in 2014.
Lynparza is a poly ADP-ribose polymerase (PARP) inhibitor that blocks enzymes involved in repairing damaged DNA. It is intended for women with heavily pretreated ovarian cancer that is associated with defective BRCA genes.
“Today’s approval constitutes the first of a new class of drugs for treating ovarian cancer,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Lynparza is approved for patients with specific abnormalities in the BRCA gene and is an example of how a greater understanding of the underlying mechanisms of disease can lead to targeted, more personalized treatment.
The FDA approved Lynparza with a genetic test called BRACAnalysis CDx, a companion diagnostic that will detect the presence of mutations in the BRCA genes (gBRCAm) in blood samples from patients with ovarian cancer. The BRCA genes are involved with repairing damaged DNA and normally work to suppress tumor growth. Women with mutations resulting in defective BRCA genes are more likely to get ovarian cancer, and it is estimated that 10 to 15 percent of all ovarian cancer is associated with these hereditary BRCA mutations.
The FDA evaluated the BRACAnalysis CDx’s safety and efficacy under the agency’s premarket approval pathway used for high-risk medical devices. Until now, the manufacturer, a clinical laboratory, had been marketing this test, although not specifically for use as a companion diagnostic, without FDA approval as a laboratory developed test (LDT), which is a test that is designed, manufactured and used in a single laboratory. The new test is approved as a companion diagnostic, specifically to identify patients with advanced ovarian cancer who may be candidates for treatment with Lynparza.
“The approval of safe and effective companion diagnostic tests and drugs continue to be important developments in oncology,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “We are very excited that the BRACAnalysis CDx is the FDA’s first approval of an LDT under a premarket approval application and is the first approval of an LDT companion diagnostic. The use of companion diagnostics helps bring to market safe and effective treatments specific to a patient’s needs.”
The FDA’s approval of the BRACAnalysis CDx is based on data from the clinical study used to support approval of Lynparza. Blood samples from clinical trial participants were tested to validate the test’s use for detecting BRCAmutations in this population.
Lynparza’s efficacy was examined in a study where 137 participants with gBRCAm-associated ovarian cancer received the drug. The study was designed to measure objective response rate (ORR), or the percentage of participants who experienced partial shrinkage or complete disappearance of the tumor. Results showed 34 percent of participants experienced ORR for an average of 7.9 months.
Common side effects of Lynparza included nausea, fatigue, vomiting, diarrhea, distorted taste (dysgeusia), indigestion (dyspepsia), headache, decreased appetite, common cold-like symptoms (nasopharyngitis), cough, joint paint (arthralgia), musculoskeletal pain, muscle pain (myalgia), back pain, rash (dermatitis) and abdominal pain. Serious side effects included the development of myelodysplastic syndrome, a condition where the bone marrow is unable to produce enough functioning blood cells; acute myeloid leukemia, a bone marrow cancer; and lung inflammation.
The most common laboratory abnormalities were increased creatinine, increased average volume of red blood cells (mean corpuscular volume elevation), decreased red blood cell count (hemoglobin), decreased white blood cell count (lymphocytes and neutrophils) and decreased platelet levels.
In June, Lynparza was reviewed by the FDA’s Oncologic Drugs Advisory Committee for potential use as maintenance therapy (treatment given to keep cancer from returning). The committee advised the agency in a vote of 11 to 2 that the data did not support Lynparza’s accelerated approval for this use. After the meeting, the company submitted additional information supporting Lynparza’s use for a different use: in patients with gBRCAm-associated ovarian cancer who have received three or more chemotherapy treatments.
The FDA is approving Lynparza under the agency’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials. Lynparza’s application was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and, if approved, would offer significant improvement compared to marketed products.
BRACAnalysis CDx’s application was reviewed under the FDA’s priority review program for devices, which provides for priority review of devices that meet certain criteria, including that the devices are intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and, if approved, would offer significant, clinically meaningful advantages compared to marketed products.
Lynparza is marketed by AstraZeneca Pharmaceuticals, based in Wilmington, Delaware. BRACAnalysis CDx is manufactured by and performed at Salt Lake City, Utah-based Myriad Genetic Laboratories, Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
T-MOBILE SETTLES CRAMMING CASE WITH FTC AND WILL PAY MINIMUM $90 MILLION
FROM: U.S. FEDERAL TRADE COMMISSION
T-Mobile to Pay At Least $90 Million, Including Full Consumer Refunds To Settle FTC Mobile Cramming Case
Settlement Requires Company To Pay Fines to States and FCC
T-Mobile has agreed to fully refund its customers for unwanted third-party charges it placed on their phone bills, a practice known as mobile cramming, paying at least $90 million to settle a Federal Trade Commission lawsuit filed earlier this year.
In addition to the full refunds T-Mobile is providing, which will resolve the FTC’s lawsuit if approved by the court, T-Mobile is paying $18 million in fines and penalties to the attorneys general of all 50 states and the District of Columbia and $4.5 million to the Federal Communications Commission.
“Mobile cramming is an issue that has affected millions of American consumers, and I’m pleased that this settlement will put money back in the hands of affected T-Mobile customers,” said FTC Chairwoman Edith Ramirez. “Consumers should be able to trust that their mobile phone bills reflect the charges they authorized and nothing more.”
Under the terms of the settlement, T-Mobile will be required to offer full refunds to all affected consumers. The amount of money the company pays must reach at least $90 million in redress or other payments. Should the company fail to do so, the balance must be remitted to the FTC for additional consumer redress, consumer education, or other uses. The settlement requires T-Mobile to contact all of its crammed customers – current and former – to inform them of the refund program and claims process, and to do so in a clear and conspicuous way.
The FTC filed suit against T-Mobile in July, alleging that the company placed millions of dollars in unwanted third-party charges on its customers’ mobile phone bills, receiving 35 to 40 percent of every charge they placed. The charges were for services like horoscopes, love tips and celebrity gossip, for which T-Mobile typically billed consumers $9.99 per month.
The FTC’s complaint alleges that in some cases, T-Mobile was charging consumers for services that had refund rates of up to 40 percent in a single month. The FTC has alleged that because such a large number of people were seeking refunds, it was an obvious sign to T-Mobile that the charges were never authorized by its customers.
According to the FTC’s July complaint, T-Mobile’s phone bills made it nearly impossible for consumers to find and understand third-party subscription charges. The FTC’s complaint against T-Mobile noted that in many instances information about the third-party charges crammed on to customers’ bills was buried deep in phone bills that totaled more than 50 pages in length.
In addition to requiring T-Mobile to provide consumers with full refunds, the settlement requires the company to get consumers’ express informed consent before placing third-party charges on their bills. The company also must ensure that consumers are notified of any third-party charges on their bills and provide them with information about the option to block third-party charges.
The FTC has brought numerous cases related to mobile cramming in recent months, taking action against mobile carriers and the third parties who place unauthorized charges.
The Commission vote approving the proposed stipulated order was 5-0. It is subject to court approval. The FTC filed the proposed stipulated order in the U.S. District Court for the Western District of Washington.
NOTE: Stipulated orders have the force of law when approved and signed by the District Court judge.
The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them.The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a variety of consumer topics. Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases for the latest FTC news and resources.
T-Mobile to Pay At Least $90 Million, Including Full Consumer Refunds To Settle FTC Mobile Cramming Case
Settlement Requires Company To Pay Fines to States and FCC
T-Mobile has agreed to fully refund its customers for unwanted third-party charges it placed on their phone bills, a practice known as mobile cramming, paying at least $90 million to settle a Federal Trade Commission lawsuit filed earlier this year.
In addition to the full refunds T-Mobile is providing, which will resolve the FTC’s lawsuit if approved by the court, T-Mobile is paying $18 million in fines and penalties to the attorneys general of all 50 states and the District of Columbia and $4.5 million to the Federal Communications Commission.
“Mobile cramming is an issue that has affected millions of American consumers, and I’m pleased that this settlement will put money back in the hands of affected T-Mobile customers,” said FTC Chairwoman Edith Ramirez. “Consumers should be able to trust that their mobile phone bills reflect the charges they authorized and nothing more.”
Under the terms of the settlement, T-Mobile will be required to offer full refunds to all affected consumers. The amount of money the company pays must reach at least $90 million in redress or other payments. Should the company fail to do so, the balance must be remitted to the FTC for additional consumer redress, consumer education, or other uses. The settlement requires T-Mobile to contact all of its crammed customers – current and former – to inform them of the refund program and claims process, and to do so in a clear and conspicuous way.
The FTC filed suit against T-Mobile in July, alleging that the company placed millions of dollars in unwanted third-party charges on its customers’ mobile phone bills, receiving 35 to 40 percent of every charge they placed. The charges were for services like horoscopes, love tips and celebrity gossip, for which T-Mobile typically billed consumers $9.99 per month.
The FTC’s complaint alleges that in some cases, T-Mobile was charging consumers for services that had refund rates of up to 40 percent in a single month. The FTC has alleged that because such a large number of people were seeking refunds, it was an obvious sign to T-Mobile that the charges were never authorized by its customers.
According to the FTC’s July complaint, T-Mobile’s phone bills made it nearly impossible for consumers to find and understand third-party subscription charges. The FTC’s complaint against T-Mobile noted that in many instances information about the third-party charges crammed on to customers’ bills was buried deep in phone bills that totaled more than 50 pages in length.
In addition to requiring T-Mobile to provide consumers with full refunds, the settlement requires the company to get consumers’ express informed consent before placing third-party charges on their bills. The company also must ensure that consumers are notified of any third-party charges on their bills and provide them with information about the option to block third-party charges.
The FTC has brought numerous cases related to mobile cramming in recent months, taking action against mobile carriers and the third parties who place unauthorized charges.
The Commission vote approving the proposed stipulated order was 5-0. It is subject to court approval. The FTC filed the proposed stipulated order in the U.S. District Court for the Western District of Washington.
NOTE: Stipulated orders have the force of law when approved and signed by the District Court judge.
The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them.The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad. The FTC’s website provides free information on a variety of consumer topics. Like the FTC on Facebook, follow us on Twitter, and subscribe to press releases for the latest FTC news and resources.
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