AG HOLDER'S REMARKS AT INTERNATIONAL ASSOCIATION OF CHIEFS OF POLICE CONFERENCE

FROM:  U.S. JUSTICE DEPARTMENT 

Remarks by Attorney General Holder at the International Association of Chiefs of Police Annual Conference

Orlando, FLUnited States ~ Monday, October 27, 2014

Remarks as Prepared for Delivery

Thank you, Chief [Yost] Zakhary, for that introduction; for your leadership as President of the International Association of Chiefs of Police; and for your dedicated service to the people of Woodway, Texas – as Police Chief, as City Manager, and as Public Safety Director – for over three decades.

It’s a pleasure to join you here in Orlando today.  And it’s a tremendous privilege, as always, to stand with so many distinguished law enforcement leaders.  I’d like to thank the IACP’s Board of Directors – and every one of your members – for inviting me to take part, once again, in this important annual conference, as we confront a range of evolving challenges and reaffirm our shared commitment to honoring all who wear the badge.

Over the course of my career in public service – and especially during my tenure as Attorney General – I have been fortunate to work closely with many of the leaders in this room, and with your colleagues across the country, to address urgent and emerging threats; to improve our collective ability to protect the communities we serve; to secure the resources we need to keep our officers safe; and to ensure that America’s criminal justice system is as fair – and as effective – as possible.

It has been among the greatest honors of my career to count you as colleagues, as partners, and as friends in advancing this important work.  For over 120 years, the IACP and its members have stood on the front lines of America’s struggle against crime, violence, and victimization.  You have been keepers of a sacred public trust, and stewards of a proud tradition of service, that predates our Republic.  And especially in recent years – in the face of sequestration, government shutdown, and other unprecedented difficulties – you have repeatedly proven the power of cooperation and collaboration across jurisdictions and even international borders, speaking out for the physical and mental health of those brave few who wear the badge – and risk their lives – to keep their communities safe.

We gather today at an auspicious moment.  Thanks to your leadership – and the extraordinary valor of every one of our officers on the street – the past two decades have been defined by dramatic reductions in criminal activity.  As you know, the rate of violent crime that was reported to the FBI in 2012 was about half the rate reported in 1993.  It has declined by more than 11 percent just since President Obama took office.  And the rate of incarceration has gone down by more than 8 percent over the same brief period – the very first time these two critical markers have declined together in more than 40 years.

This signal achievement owes a great deal to the courage, and the profound sacrifices, of our men and women in law enforcement – each of whom shoulders tremendous burdens, at great personal risk, in order that others might live safe and free.  As we come together here in Orlando, we must bear in mind just how challenging – and how often thankless – their vital work can be.  We have a great deal of work to do when it comes to increasing support for law enforcement officials and their families; forging close bonds of trust between our officers and the communities they serve; and overcoming the mistrust and misunderstanding that some people bring to interactions with the police – and that some officers may bring to interactions with certain communities.

But as we open a new chapter in this important conversation, we must never lose sight of the immense and unyielding difficulties that are inherent in the law enforcement profession – from the dangers these brave men and women face every time they put on their uniforms, to the split-second decisions they often must make, to the anguish of family members who awaken at night to the sound of a ringing telephone –hoping for the best, but fearing tragic news about a loved one out patrolling the streets.

As our nation’s Attorney General, I have always been proud – and steadfast – in my support for law enforcement personnel and their families, who make tremendous and often unheralded sacrifices every single day to keep us safe.  These sacrifices are too often overlooked.  And I believe we do ourselves, our communities, and our nation a grave disservice if we ignore these difficulties – just as we do ourselves a disservice if we dismiss, or fail to address, the conditions and lingering tensions that exist just beneath the surface in so many places across the country – and that were brought to the surface, and raised to the urgent attention of this group and others, by this summer’s events in Ferguson, Missouri.

As law enforcement leaders, it is incumbent upon each of us to take constructive, inclusive steps to rebuild trust and instill respect for the rule of law in all of the communities where these tensions are uncovered.  This is something that our new Acting Assistant Attorney General for the Civil Rights Division, Vanita Gupta – who’s here with us today – understands well.  She recognizes, as we all do, that this is best accomplished through a collaborative process with law enforcement, with the proactive leadership of OJP and the COPS Office, under Karol Mason and Ron Davis.  We are all committed to standing with you in the effort to build trust.  And fortunately, thanks to robust partnerships that bind the Department of Justice to the IACP – and the innovative work of so many of the chiefs who are here in Orlando today – together, we are making great strides to do just that.

As a result of the leadership that so many local police are providing – and the Justice Department-led reform efforts that are underway in St. Louis County and elsewhere – we are making this effort a focused, national priority.  The Justice Department has launched a substantial new program – known as the National Initiative for Building Community Trust and Justice – to enhance procedural justice, to reduce implicit bias, and to support racial reconciliation.  Through this and other programs – as in our regular interactions with exemplary law enforcement executives like you – my colleagues and I are doing important work to see that tensions are addressed, rather than swept under the rug; to build dialogue and bridge longstanding divides; and to ensure fair treatment for everyone who comes into contact with police – while enhancing citizen compliance with law enforcement authorities.

At its core, this is about far more than addressing the issues highlighted by the intense public response to events in Ferguson.  It’s about practicing sound and effective law enforcement.  That’s why, under the leadership of our COPS Office, the Justice Department is working with the IACP and others to conduct a broad review of policing tactics, techniques, and training –so we can help the field swiftly confront emerging threats, better address persistent challenges, and thoroughly examine the latest tools and technologies to enhance the safety, and the effectiveness, of law enforcement.

Going forward, I will support not only continuing this targeted review, but expanding it – to consider the profession in a comprehensive way – and to provide strong, national direction on a scale not seen since President Lyndon Johnson’s Commission on Law Enforcement nearly half a century ago.

After all, we’ve come to understand over the years that – when people have faith in the integrity of the process – they are more likely to cooperate with local authorities and obey the law, even if they disagree with particular outcomes.  And that’s why our COPS Office has invested more than $14 billion to keep our streets and communities safer through community policing – funding over 126,000 officers; awarding approximately 39,000 grants to state, local, tribal, and territorial law enforcement agencies; and training more than 700,000 law enforcement personnel, community members, and government leaders.

In September, I announced a new round of investments in this work – in the form of nearly $124 million in grants under the COPS Hiring Program.  This important funding will support the hiring and retention of 944 officers at 215 agencies and municipalities around the country.  And the impact of these grants will extend far beyond the creation and preservation of law enforcement jobs – helping to strengthen relationships between these officers and the communities they serve, to improve public safety, and to keep more officers on the streets.

This has the potential to make a profound, positive difference in the lives of millions of people.  But it’s only the beginning.

Through our highly successful Byrne Justice Assistance Grants – or Byrne-JAG – the Bureau of Justice Assistance, a part of our Office of Justice Programs, has awarded nearly $290 million in funding to 56 states and territories, and more than 1,000 local jurisdictions, during the last fiscal year alone.  These resources are helping to spur innovation and drive evidence-based policing in countless communities.  And thanks to initiatives like VALOR, which has trained more than 15,000 officers at over 110 training events – and ALERRT, our active shooter response training partner through VALOR, which has trained over 50,000 officers – we’re making good on our commitment not only to ensure success, but to promote safety, among law enforcement professionals throughout America.

By helping to prevent violence, to improve officer resilience, and to increase survivability during violent encounters – including ambushes and active shooter situations – the Justice Department is empowering our local, state, and tribal partners.  And under our Bulletproof Vest Partnership Program, we’re also helping to provide access to the lifesaving equipment that they need to stay safe.

Since we launched this important program in 1999, the Department has awarded more than $390 million toward the purchase of over 1.1 million bulletproof vests.  In 2013 and 2014 alone, protective vests saved the lives of at least 31 law enforcement and corrections officers.  And three of their vests were purchased, in part, with BVP funds.

Beyond these efforts, the Justice Department is striving to expand access to the tools our law enforcement officials need to counter a wide range of evolving public safety threats, from human trafficking to opioid addiction.  I’m pleased that a new e-Guide – available from our Office for Victims of Crime – gives law enforcement and victim service providers the information and insights they need to respond effectively to crimes involving forced sex and labor.  This updated resource will help strengthen anti-human trafficking task forces now in operation across the country.

And as we face down the growing threat posed by addiction to heroin and other opioids – including prescription painkillers – I’m proud to announce that the Justice Department is rolling out a new online toolkit to help law enforcement professionals respond to drug overdose emergencies both safely and effectively.

Because local police officers are often the first to arrive on the scenes of these overdoses, it is absolutely critical that we equip them to respond appropriately.  As you know, naloxone – also known as Narcan – is a fast-acting drug that’s extremely effective at restoring breathing to a victim in the midst of a heroin or other opioid overdose.  In recent months, I have begun urging local law enforcement authorities to equip their officers with naloxone.  I’ve directed federal law enforcement agencies under the authority of the Justice Department to review their policies to determine whether their personnel should also be equipped with this potentially-lifesaving remedy – just as ATF Special Response Team medics have been for some time now.  And in the course of my regular interactions with leaders like you, I’ve heard a number of requests to offer new information and assistance to public safety professionals who carry this drug.

In response, we’ve assembled new online toolkit, comprising over 80 resources from 30 contributing law enforcement and public health agencies.  This naloxone toolkit is available today on the Bureau of Justice Assistance’s website.  And I encourage you all to take full advantage of the information it provides.

Coupled with the targeted reforms we’ve made under the “Smart on Crime” initiative I announced last year, I am confident that these efforts will save and improve lives while conserving precious resources.  As you know as well as anyone, we must never – and we will never – stop being vigilant against crime, or the conditions and choices that breed it.  But investing in effective prevention, treatment, and rehabilitation; ensuring that incarceration is used appropriately – and reserving the toughest penalties for serious, violent, or high-level traffickers – can only serve to strengthen our criminal justice system as a whole.

Now, I know there are some who have suggested that recent changes in charging and sentencing policies might somehow undermine our ability – at the federal level – to induce cooperation from defendants in certain cases.  But – as I know from experience, and as so many of the seasoned law enforcement leaders in this room surely recognize – the reality is that these concerns are overstated.

Defendant cooperation depends on the certainty of swift and fair punishment, not on the length of a mandatory minimum sentence.  Like anyone old enough to remember the era before sentencing guidelines existed and mandatory minimums took effect, I can testify to the fact that federal guidelines attempted to systematize the kinds of negotiations that were naturally taking place anyway.  Far from impeding the work of federal prosecutors, the sentencing reforms I’ve mandated have strengthened their discretion.  And the belief that cooperation is wholly dependent on mandatory minimums does not align with objective facts.

Going forward – with these important, commonsense changes; with the resources and support the Justice Department is providing; and with the strong leadership of the IACP and each of its members – I am confident that we will continue to see crime and violence decrease in all of the jurisdictions represented here.  We will continue to ensure that America’s finest can protect themselves, and secure their communities, as effectively as possible.  And – with dedication and persistence, in partnership with one another, and thanks to the bravery of our men and women on the front lines – we will continue to make the progress that our citizens both need and deserve.

In the weeks ahead – wherever my individual path may take me – I want you to know that my commitment to this work, and my abiding respect and admiration for you and your colleagues, will never waver.  I am proud of all that we have accomplished together over the last six years.  I look forward to everything we will achieve in the critical days to come.  And I thank you all, once again, for your tireless work, for your friendship – and for your ongoing service to the nation we love so dearly.

SECRETARY KERRY MEETS WITH EMBASSY STAFF IN MEXICO CITY

FROM:  U.S. STATE DEPARTMENT

Meeting With Embassy Mexico City Staff

Remarks

John Kerry

Secretary of State

Mexico City, Mexico

May 21, 2014

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AMBASSADOR WAYNE: Okay. Good afternoon, everybody. It’s a great honor for me to have the pleasure of introducing Secretary of State John Kerry. Mr. Secretary, thanks for carving out this time on your first official visit as Secretary of State to Mexico City. As you can see, we have a great, dedicated team here of Mexicans and Americans who work together on all sorts of issues to make our relationship better and to promote our interests. But we’re really pleased that you’re with us and we very much appreciate all the hard work and dedication that you have been showing in the service of our country as Secretary of State, and helping give us guidance and the other embassies around the world.

So thanks very much for being with us, and I give you the Secretary of State. (Applause.)

SECRETARY KERRY: Thank you. Thank you very much. Thank you. Thank you. Muchas gracias. Thank you very, very much, Tony. Muy buenas tardes. How are you? Everybody good? Como les va?(Laughter.) Okay. You got some energy in here. Thank you. Thank you, (inaudible). That is the best welcome I’ve had anywhere in the world. Thank you. (Applause.) I love it. Somebody said somebody up there had something to do with the Navy? Is that true? Are you guys a Navy mariachi band? (Laughter.) I was in the Navy; I never knew we could do that. (Laughter.) That’s outstanding. Thank you guys very, very much. Really appreciate it. I’d love to hear more. We can dance and whatever into the night.

I am really, really happy to be here, very privileged to be here with Tony, who is really an outstanding ambassador. He’s had extraordinary experience. Been here since 2011 I guess, and is doing an amazing job of not just marshaling this very, very important relationship, but also managing the extraordinary transition that is taking place here. We just keep getting bigger and bigger. I think we’ve got 2,700 people, 1,700 of whom are local employees. And I want to say a huge, huge thank you –muchas gracias – to those of you who work here, giving of yourselves to the effort of the United States to help build our relationship with Mexico. Everyone here is really grateful to you for what you do, so thank you very, very, very much. Thank you. (Applause.)

I know a lot of you are very nervous about what’s going to happen with this transition to the new embassy compound. I promise you I will exert all the power of the Secretary of State to make absolutely certain that when you move into the new compound, the jugo verdes will flow. (Laughter.) Does that matter to you or not? I don’t know. I was told it’s a big deal around here. Is that true? No. Only with some of you. How many people love it? Jugo verdes, right? That’s all. I’ve been misinformed. What’s the matter with the rest of you? What’s the matter with jugo verdes? (Laughter.)

Let me just say to everybody here, President Obama has now been out here five times, and Vice President Biden was obviously here last September. The President was here most recently, and now I’m here on my first trip as Secretary of State – and I promise you not my last trip. And I want to just emphasize how really both exciting and critical this relationship is. I just looked over here and I see Laura Dogu, our DCM, who is also the winner of the Baker-Wilkins Award for best DCM around. So congratulations to you. (Applause.) And her husband, Aydin , who I just met. Thank you both very much, and thank you very much, Laura, for that extraordinary leadership.

I just came from a really, really unbelievably friendly, open, constructive meeting with President Pena Nieto. And I tell you, it’s interesting to listen to him talk about the possibilities of this relationship and what we’ve achieved and what we want to achieve. Obviously, we have challenges. That’s why you’re here in these numbers. This is a critical relationship. It’s our hemisphere; it’s our neighbor; it’s an historic, long cultural attachment with enormous possibilities and potential to still develop and define. And when I think of the journey – I spent 29 years in the United States Senate – when I think of the journey from the early days of that incredibly divisive and difficult fight over NAFTA, and now you look at this journey and what has been accomplished. Our economy has grown, our jobs have grown, our jobs have gone through an incredibly sort of revolutionary kind of transition as we’ve modernized and moved into the technology era, the management of data and information, new kinds of jobs. And Mexico is doing exactly the same thing. And now we’re working on this absolutely critical relationship, the T – actually two relationships, but the TPP, which is going to be critical to all of us with respect to Asia Pacific, the Asia – and the future of the relationship in terms of both jobs and security. There are masses of young people all around the world looking for opportunity and for jobs.
The challenge to governance is really greater than it’s ever been. We have to deliver, and it requires a kind of cooperative effort that is different from anything we’ve ever known. We have this extraordinary amount of money – a billion dollars a day, unbelievable economic relationship that is moving one way and the other way between our nations. We have a million people a day crossing the border legally one way or the other. It’s an astounding relationship in that regard. And we’re only tapping into it because there’s still too many people yet to fully reach their economic potential in our country and in Mexico. So that’s the challenge, together with the challenge, obviously, of people who don’t like anything to do with modernity or who want to fight back against law and rule of law and structure. So Mexico is fighting some of that battle, and we’re trying to help them do that.

We have a whole bunch of unaccompanied children crossing over the border. It’s an enormous challenge, and we need to meet the challenge even as we are trying to fix our immigration laws, which I hope we could do this year. We passed that bill in the Senate. We now need to and want to pass it in the House of Representatives. I still have hopes that might be possible this year, and that would revolutionize the relationship between us.

But we have to make certain that we don’t let people exploit that issue or create problems with it, so we need to get ahead of it. We have too many guns coming from the United States of America into Mexico. We need to do our fair share of making certain that that’s not disrupting their capacity to fully develop and reach their potential, and to control the communities and the streets and not have chaos in certain places, or challenges by criminal enterprises.
So this is hard stuff. Building community is hard work, but it works. You can see it. You can measure the difference that we are making together every day in our countries, and particularly nearer the borders and in the communities that feel the greatest impact of the flow of those people.

So I just want to say thank you to you for what you’re doing. It’s a big embassy; it’s one of our biggest in the world, and it probably is going to grow, because the population’s going to grow and the challenges are going to grow. And when you add all the consulates and the 20 – I think it’s 26 agencies that – 29 agencies – 29 agencies that are all working together in a coordinated way, that’s more agencies by far than almost every other embassy in the country – in the world has.

So this is a big deal, and I am very, very happy to finally be able to get here and begin a series of engagements which we think are going to mature over the next year on the innovation, research, education front. The bilateral discussion that we had today where we’re actually pinning down real steps that we can take to guarantee that we’re going to expand the opportunities of Fulbright English language, of students moving across both borders both ways and learning in each other’s countries – that’s how you build relationships. I’ve seen that all over the world. I can’t tell you how many foreign ministers, finance ministers, environment ministers, prime ministers, presidents I meet somewhere in the world who brag to me privately how pleased and excited and incredibly affected they were by their relationship to the American university that they went to in their youth. And it builds a foundation of understanding, a relationship on which we have an ability to get through, sometimes, the toughest times.
So a profound thank you to every single one of you. You – I say this everywhere I go because I believe it: We, all of us – me, you, everybody involved in this – gets to wake up every morning – a lot of people who go to work don’t – liking what you do, loving the fact that you get to make a difference in the lives of other people and in the life and definition of your country. If you’re a local employee, Mexican working to help Americans do that, you’re still – you’re making a difference for Mexico and for the United States. And if you’re American, you’re making a difference for both, and that’s the way you build community, that’s the way you build stability, that’s the way you provide opportunity to young people, that’s the way you build the future. How many people get to get up and not punch the clock or go in or do something where they don’t feel that way? So it’s a blessing. And I hope we all work very, very hard as part of a family, which is what we are in the State Department, to keep it that way.

So thank you all. God bless you for what you do, and keep on doing, all the way (inaudible). (Applause.)

PARTICIPANT: (Off-mike.)

SECRETARY KERRY: Oh, my gosh. Yeah. Let me – I actually wrote a note down on that. I want to call everybody’s attention to two very, very special people: Arturo Montaño Robles – (applause) – and Ana Elena Tappan Alvarado. (Applause.) I can’t believe either of them, they look so young. I can’t believe either of them have worked here in Mexico City at this embassy for 42 years. That is amazing – amazing. (Applause.) Thank you.

And I want to – no, no, don’t go away. Don’t go away. Don’t go away. Stay here. No, no. (Laughter.) I want you to say thank you also, because everybody here knows that you don’t just serve alone; your families serve when you come home late at night, and you’re traveling, you’re doing whatever or you’ve had to leave them for a while. The families also contribute. And I particularly want to call attention – Arturo’s wife, Lucinda, and his daughter, Lucy, are here. You guys stand up and let everybody say thank you to you too, okay? Thank you, Lucy. (Applause.)
And Ana Elena has brought her brother and her sister, Ricardo and Silvia. Ricardo, Silvia, thank you very, very much. (Applause.) No, don’t get up. That’s okay. Thank you. Thank you so much. Thank you. Thank you for the reminder.

ASSISTANT AG DELERY'S ADDRESSES CBI PHARMACEUTICAL COMPLIANCE CONGRESS

FROM:  JUSTICE DEPARTMENT 
Assistant Attorney General Stuart F. Delery Delivers the Keynote Address at the CBI Pharmaceutical Compliance Congress
Washington, DC ~ Wednesday, January 29, 2014

Thank you, Cindy [Cetani, Chief Compliance Officer of Novartis Pharmaceuticals Corporation].   And thank you to the Pharma Congress co-chairs and organizers for inviting me to be here this morning.

I am especially pleased to have the chance to speak to you at a gathering dedicated to compliance in the pharmaceutical industry.   As head of the Civil Division at the Department of Justice, I oversee much of the federal government’s civil litigation in courts across the country.   Attorneys in the Civil Division litigate cases involving national security and immigration policy.   They defend federal statutes, regulations, and programs, ranging from the Affordable Care Act to actions taken in response to the financial crisis.

Yet among these significant matters, one of my top priorities is the work the Civil Division does to enforce the Food, Drug, and Cosmetic Act; the False Claims Act; and other laws protecting the safety and well-being of patients and the general public.

Why is health care enforcement so important?   A major reason is the importance of the health care industry itself.   From compliance officers to physicians, from corporate executives to nurses and researchers, you contribute to producing the drugs and medical devices on which we and our loved ones rely.   Your efforts help to ensure that, when we are sick, the medicines we take will heal us effectively; that when we are in pain, we can obtain relief safely.

This Administration shares your commitment to improving the nation’s health care system.   It has undertaken a comprehensive effort to ensure that more people have access to quality coverage, and that treatments are available at a lower cost to all of us – to patients, to health care providers, and to taxpayers.   The innovative reforms and anti-fraud measures under the Affordable Care Act are a part of this effort.

So, too, is the Health Care Fraud Prevention and Enforcement Action Team, or HEAT, a cabinet-level initiative to increase coordination between the Civil Division and our partners at the Food and Drug Administration, the Centers for Medicare and Medicaid Services, and U.S. Attorneys’ offices around the country.   This coordination has produced historic results.   Since 2009, judgments and settlements under the FCA and FDCA have totaled over $20 billion.

But monetary results tell only part of the story.

Through our enforcement efforts, the government aims to promote an environment in which all of us can count on the soundness and efficiency of the health care system.   If a pharmaceutical company pays kickbacks to physicians who prescribe its drugs, patients lose confidence that their doctors are making independent judgments about treatment options.   If a Medicare provider bills for unnecessary services, taxpayers lose faith that our money is being well spent and health care becomes more expensive for everyone.   If a manufacturer markets its products for uses that were never approved as safe and effective by the FDA, we worry that our loved ones might be receiving treatments that will harm them rather than help them, and that they may not elect the treatment with the best chance for a cure.

We are pursuing a broader range of health care fraud matters than ever before.   We have cracked down on elder abuse in nursing homes, bringing criminal and civil cases against companies that harm seniors by providing grossly deficient care.   We have pursued doctors who put patients at risk by performing unnecessary procedures to increase their bills, like a Florida dermatologist who performed thousands of unnecessary skin surgeries, participated in an illegal kickback scheme, and ultimately paid one of the largest False Claims Act settlements ever by an individual – $26.1 million.   We have gone after the manufacturers of defective medicines or medical devices, as in our criminal and civil cases against a Boston Scientific subsidiary for knowingly selling defective cardiac defibrillators.   We have sued companies that produce sterile products in non-sterile conditions, risking contamination and threatening patients with the possibility of dangerous infections.   In short, we have demonstrated a commitment to targeting health care fraud and abuse wherever we find it.

By going after the practices that shake our trust in the marketplace and risk harm to us when we need medical care, we seek to make our health care system work better.

And in that respect, we all need to be allies and partners.   When the focus is on financial recoveries, or on a specific investigation, it is easy to think of government and industry as adversaries.   But when the goal is ensuring that Americans can trust the drugs they take and the medical advice they receive, it is clear that we are on the same side, attempting to stop unlawful practices that affect the safety and affordability of pharmaceuticals and medical devices.

And so I want to focus my remarks on three ways in which I believe the Civil Division’s anti-fraud enforcement interests align with your interests as corporate compliance officers, executives, and advisors.

First, we have a common interest in promoting an ethical corporate culture instead of maintaining a compliance program in name only.

No matter how well-designed a compliance program is, it cannot achieve its goals without achieving buy-in at all levels of the company.   People must have the right incentives to see, report, and fix problems.

A common thread in many of our cases is that numerous individuals – ranging from executives to safety technicians – saw signs that misconduct was taking place and did not act.   For example, in May 2013 the generic drug manufacturer Ranbaxy pleaded guilty to felony charges relating to producing and distributing adulterated drugs from two of its manufacturing facilities in India.   Ranbaxy acknowledged that it had continued to distribute drugs that had failed critical tests, violated current Good Manufacturing Practices, and falsified records to cover up systematically incomplete testing, sometimes performing stability tests weeks or months after the dates reported to the FDA.

The conduct that gave rise to Ranbaxy’s guilty plea took place over a period of years, during which the company received early warnings that something was wrong.   The company hired auditors and started to investigate evidence of abuses.   But its actions never translated into real change.   Four years after the first signs of trouble, those problems led the company to distribute an epilepsy drug that failed tests, had unknown impurities, and would not maintain its expected shelf life.   The ultimate result was a $500 million resolution – the largest drug safety settlement ever with a generic drug manufacturer.

A scenario like this is, in many ways, a compliance officer’s worst nightmare.   And it demonstrates how a company can have the tools it needs to avoid violations of law, and yet have such violations happen anyway. To be sure, Ranbaxy’s compliance operation could have done more than it did – its auditors, for instance, said that the company badly needed cGMP training; that training never happened.   But policies alone are not enough.

That is why we have put a renewed emphasis on identifying non-monetary measures that will help us to prevent the recurrence of misconduct. That happened with Ranbaxy, where an earlier civil consent decree called, among other things, for the company to establish an Office of Data Reliability that would work with its manufacturing, testing, approval, and compliance operations to ensure that all future drug applications are audited for accuracy before submission.   Indeed, just last week, the consent decree allowed FDA to move swiftly and respond forcefully when it learned of problems at yet another Ranbaxy facility.

Non-monetary measures were also a key feature of our $1.5 billion criminal and civil resolution in 2012 with Abbott Laboratories for conduct relating to its epilepsy drug Depakote.   Working with the company and with our partners in Office of the Inspector General of the Department of Health and Human Services, we crafted a resolution designed to ensure high-level accountability for the company’s compliance efforts.   It imposes a term of probation for five years which requires Abbott to report any probable violations of the FDCA, and requires that its CEO personally certify compliance with this reporting requirement.   It contains a corporate integrity agreement with the HHS-OIG that requires, among other things, Abbott’s board of directors to review the efficacy of the company’s compliance effort.   And it demands that Abbott institute policies to ensure that its scientific research and publications foster increased understanding of scientific, clinical, or healthcare issues.

As these settlements have made clear, we are not interested in merely collecting a large fine and moving on to the next case.   We strive to give companies the incentives – and the tools – to craft better compliance practices in the future.   And we want to work together with you, the people most responsible for compliance, to achieve real change.

The second common interest between the government and industry that I want to highlight is transparency about the conduct we investigate.

The impact of the cases we bring extends beyond the individuals and companies whose wrongdoing is at issue. Given the size, scope and reach of the pharmaceutical industry, we recognize that our efforts can have a profound impact, not only on the pharmaceutical industry, but also on the lives of countless Americans.   Each victory we achieve in fighting a single instance of fraud helps to deter others from following the same path.

In order for this comprehensive approach to be successful, we must be clear about what misconduct gave rise to a criminal or civil resolution.   As a result, we continue to emphasize the importance of   explaining the conduct that has given rise to the settlements we negotiate.

That kind of transparency benefits the industry by clarifying the factual basis for the actions we take.   And it benefits the American people by maximizing the impact of each dollar spent on health care fraud prevention and by prompting other companies to avoid the same risks to patient health and safety.

Being transparent about our enforcement efforts also means distinguishing conduct that is lawful and even beneficial from conduct that is illegal and harmful.   For example, we recognize the value of giving doctors the freedom to decide, in consultation with their patients, what treatments to use.   And we acknowledge the importance of an open dialogue in which pharmaceutical companies and physicians share truthful information about a product’s likely effects.

That said, where a company crosses the line and distributes its products intending them to be used in ways that are not approved as safe and effective by the FDA, we will act aggressively.

Many of you are familiar with November’s $2.2 billion settlement with Johnson & Johnson.   In that case, the government alleged, among other things, that a J&J subsidiary, Janssen Pharmaceuticals, distributed the antipsychotic drug Risperdal to the nation’s most vulnerable patients – elderly nursing home residents, children, and individuals with mental disabilities – for uses that the FDA had never approved.   Indeed, according to the government, Janssen distributed the drug to health care providers for elderly, non-schizophrenic dementia patients despite knowing that those uses were not approved and that the drug posed serious health risks to the elderly, including an increased risk of stroke.

Misbranding like this undermines the regulatory regime that we rely on to ensure that medicines and medical devices are safe.   And it can have catastrophic consequences for patients.   That is why the government will continue to bring these cases, and why we think it is so important that the public – and the industry in particular – understand the conduct at issue.

Finally, third, we have a common interest in ensuring that corporate compliance not only is the right thing to do but also is a winning business strategy.

That means pursuing companies that seek an unfair advantage by breaking the law.   The World Health Organization, for example, estimates that more than half of the drugs sold online are counterfeit and contain useless or even harmful ingredients.   And so the Civil Division has a team of attorneys who pursue counterfeit pharmaceutical fraud.   These efforts are critical to protecting the millions of Americans who purchase their medications through online pharmacies.   But they are also critical to protecting the legitimate businesses that suffer when fraudulent conduct distorts the marketplace.   We want to ensure that companies that are committed to doing things right have the opportunity to compete on a level playing field.

Rewarding compliance also means acknowledging when companies and individuals do the right thing and voluntarily disclose wrongdoing.   We recognize that most pharmaceutical companies are trying to play by the rules, that navigating the health care landscape is not always easy, and that many companies and individuals do their best to get it right.  

We want to make clear that the decision to come forward is the right one.   When a company or individual acts responsibly by timely and voluntarily disclosing unlawful conduct, we will give serious consideration to that disclosure in deciding whether or how to charge or resolve the matter.    Likewise, we will credit actions taken once the government has started to investigate.

Of course, each case is unique, so there is no one formula for cooperation – just as there is no formula for the penalty for wrongdoing.   But if we all aim to encourage a culture of compliance, to implement policies that can identify problems early, and to work together when fraud is found, your companies and your customers will be in the best possible position.

I want to close by emphasizing how seriously the Justice Department takes its responsibility to ensure that fraud does not pay – to ensure that all of you who encourage your organizations to act ethically are rewarded for doing so.

We reject the pernicious idea that a company can succeed by violating the law and treating health care fraud enforcement as a cost of doing business.   We continue to insist on resolutions that eliminate any economic incentive to engage in and attempt to conceal unlawful conduct.   We continue to seek criminal penalties, against both companies and individuals, under appropriate circumstances.   We continue to demand accountability by vigilantly enforcing federal laws against those who seek an unfair advantage at the expense of patients and taxpayers.

A competitive health care marketplace, undistorted by fraud, is good for providers as well as patients.   That is why I am so pleased to be here and so convinced that events such as this are vital.   These gatherings enhance our respective practices and our understanding of our respective positions.   They allow all of us to consider new ideas and varying perspectives.   And they allow us to explore new ways to work together to enhance Americans’ trust in their health care systems.

I thank the organizers for the chance to address these issues with you, and I look forward to continuing to work with all of you in the future.  

Thank you.