LABELING MEDICAL PRODUCTS NOT MADE WITH RUBBER LATEX

Credit:  U.S. Army.

FROM: U.S. FOOD AND DRUG ADMINISTRATION
FDA issues draft guidance for manufacturers to accurately label medical products that are not made with natural rubber latex


The U.S. Food and Drug Administration today issued draft recommendations to medical product manufacturers for providing consumers with accurate information about products that are not made with natural rubber latex (NRL).

NRL is a milky fluid found in rubber trees and other plant sources. Prolonged or repeated exposure to NRL can result in sensitivity or allergy. Mild reactions may include skin redness, rash, hives, or itching. More severe reactions may include respiratory symptoms such as difficulty breathing, coughing spells and wheezing. Rarely, anaphylactic shock may occur.

The FDA is encouraging manufacturers of FDA-regulated medical products to stop using statements on labels such as "latex free" or "does not contain natural rubber latex" because these statements are not scientifically accurate. Instead, the FDA recommends manufacturers use the labeling statement – "not made with natural rubber latex" – to indicate when NRL was not used as a material in the medical product or product container.

"Consumers rely on and expect accurate labeling and product information, especially when they are concerned about allergic reactions," said William Maisel, M.D., M.P.H., deputy director for science in the FDA’s Center for Devices and Radiological Health. "Our recommendations regarding natural rubber latex provide consistent, scientifically accurate language for health care providers, patients and consumers who want to avoid this material due to possible sensitivity or allergy."

The terms "latex free" and "does not contain natural rubber latex" suggest that the medical product is completely without NRL. However, even when medical products are not made with NRL, there is a chance that products can become contaminated with NRL allergens during manufacturing or packaging processes. There is no test to show that a medical product is completely free of NRL allergens. Additionally, it is not necessary for a medical product to be completely without NRL allergen proteins to be considered safe for use by some individuals with NRL allergies.

Also, phrases such as "latex free" that are not specific about the kind of latex being referred to can cause confusion. Latexes may be natural or synthetic. Synthetic latex, such as nitrile and polyvinyl chloride, does not contain the proteins responsible for NRL allergy.

People most at risk for NRL sensitization include those who frequently use NRL gloves such as physicians, nurses, dentists, medical technicians, hairdressers, housekeepers, and food service workers. Employees in facilities that manufacture products containing NRL are also at risk.

Consumers concerned about NRL allergies should check the medical product label, if readily available, or ask their health care provider if the product of interest contains NRL.

Today’s draft recommendations would apply only to FDA-regulated medical products, such as drugs, medical devices, biologics and veterinary products. The law does not require medical product manufacturers to state on the product labeling when NRL has not been used in the manufacture of the product or product packaging. However, medical device manufacturers are required to include a caution statement on the labeling of devices that are made with NRL.

HHS WARNS HELATH SCAMS CAN BE DANGEROUS

Photo:  Rattlesnake.  Credit:  Wikmedia Commons.

FROM: U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

From the U.S. Department of Health and Human Services, I’m Ira Dreyfuss with HHS HealthBeat.

This’ll cure you? Or make you lose weight?

Not necessarily. Health scammers are good at taking your money and bad at delivering what they promise. So a smart shopper has to tell the difference between what looks good in the ad or on the Net and what the product really is.

At the U.S. Food and Drug Administration, Gary Coody is an expert in detecting health fraud. He says that, if it’s an unproven or little-known treatment, ask your doctor.

"Alarms should go off when you see words like ‘new discovery’ or ‘scientific breakthrough’ or ‘secret ingredient’ or ‘all natural miracle cure.’’’

Because it’s not just the money you can lose. Some of the fakes can be dangerous. And relying on the fakes can delay getting real treatment, while the condition you want to treat just gets worse

U.S. FDA APPROVES ELIQUIS TO REDUCE RISK OF STROKE AND BLOOD CLOTS IN CERTAIN PATIENTS

FROM: U.S. FOOD AND DRUG ADMINISTRATION

FDA approves Eliquis to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation
The U.S. Food and Drug Administration today approved the anti-clotting drug Eliquis (apixaban), an oral tablet used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.

Atrial fibrillation, one of the most common types of abnormal heart rhythm, is an abnormal, irregular, and rapid beating of the heart in which the heart’s two upper chambers (atria) do not contract properly, allowing blood clots to form in them. These clots can break off and travel to the brain or other parts of the body.

"Blood clots in the heart can cause a disabling stroke if the clots travel to the brain," said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. "Anti-clotting drugs lower the risk of having a stroke by helping to prevent blood clots from forming."

The safety and efficacy of Eliquis in treating patients with atrial fibrillation not caused by cardiac valve disease were studied in a clinical trial of more than 18,000 patients that compared Eliquis with the anti-clotting drug warfarin. In the trial, patients taking Eliquis had fewer strokes than those who took warfarin.

Patients with prosthetic heart valves should not take Eliquis nor should patients with atrial fibrillation that is caused by a heart valve problem. These patients were not studied in clinical trial. As with other FDA-approved anti-clotting drugs, bleeding, including life-threatening and fatal bleeding, is the most serious risk with Eliquis. There is no agent that can reverse the anti-coagulant effect of Eliquis.

Eliquis will be dispensed with a patient Medication Guide that provides instructions on its use and drug safety information. Health care professionals should counsel patients on signs and symptoms of possible bleeding.

Eliquis is manufactured Bristol-Myers Squibb Company of Princeton, N.J. and marketed by BMS and Pfizer Inc. of New York.

U.S. FDA TIPS ON FOOD AND WATER SAFETY DURING DISASTERS

Photo Credit:  U.S. Food And Drug Administration.

FROM: U.S. FOOD AND DRUG ADMINISTRATION
What Consumers Need to Know About Food and Water Safety During Hurricanes, Power Outages, and Floods

Be Prepared for EmergenciesMake sure you have appliance thermometers in your refrigerator and freezer.
Check to ensure that the freezer temperature is at or below 0 °F and the refrigerator is at or
below 40 °F.
In case of a power outage, the appliance thermometers will indicate the temperatures in the refrigerator and freezer to help you determine if the food is safe. Freeze containers of water for ice to help keep food cold in the freezer, refrigerator, or coolers in case the power goes out. If your normal water supply is contaminated or unavailable, the melting ice will also supply drinking water.
Freeze refrigerated items such as leftovers, milk, and fresh meat and poultry that you may not need immediately. This helps keep them at a safe temperature longer.
Group food together in the freezer. This helps the food stay cold longer.
Have coolers on hand to keep refrigerated food cold if the power will be out for more than 4 hours.
Purchase or make ice cubes in advance and store in the freezer for use in the refrigerator or in a cooler. Freeze gel packs ahead of time for use in coolers.
Check out local sources to know where dry ice and block ice can be purchased, just in case.
Store food on shelves that will be safely out of the way of contaminated water in case of flooding.
Make sure to have a supply of bottled water stored where it will be as safe as possible from flooding.
Power Outages: During and After

When the Power Goes Out . . .

Here are basic tips for keeping food safe:
Keep the refrigerator and freezer doors closed as much as possible to maintain the cold temperature.
The refrigerator will keep food cold for about 4 hours if it is unopened.
A full freezer will keep the temperature for approximately 48 hours (24 hours if it is half full) if the door remains closed.
Buy dry or block ice to keep the refrigerator as cold as possible if the power is going to be out for a prolonged period of time. Fifty pounds of dry ice should hold an 18-cubic foot fully-stocked freezer cold for two days. If you plan to eat refrigerated or frozen meat, poultry, fish or eggs while it is still at safe temperatures, it's important that each item is thoroughly cooked to the proper temperature to assure that any foodborne bacteria that may be present is destroyed. However, if at any point the food was above 40 °F for 2 hours or more — discard it.
Wash fruits and vegetables with water from a safe source before eating.
For infants, try to use prepared, canned baby formula that requires no added water. When using concentrated or powdered formulas, prepare with bottled water if the local water source is potentially contaminated.
Once Power is Restored . . .

You'll need to determine the safety of your food. Here's how:
If an appliance thermometer was kept in the freezer, check the temperature when the power comes back on. If the freezer thermometer reads 40°F or below, the food is safe and may be refrozen.
If a thermometer has not been kept in the freezer, check each package of food to determine its safety. You can't rely on appearance or odor. If the food still contains ice crystals or is 40 °F or below, it is safe to refreeze or cook.
Refrigerated food should be safe as long as the power was out for no more than 4 hours and the refrigerator door was kept shut. Discard any perishable food (such as meat, poultry, fish, eggs or leftovers) that has been above 40°F for two hours or more.
Keep in mind that perishable food such as meat, poultry, seafood, milk, and eggs that are not kept adequately refrigerated or frozen may cause illness if consumed, even when they are thoroughly cooked.

When Flooding Occurs — Keep Water Safe

Follow these steps to keep your WATER SAFE during — and after — flood conditions.
Use bottled water that has not been exposed to flood waters if it is available.
If you don't have bottled water, you should boil water to make it safe. Boiling water will kill most types of disease-causing organisms that may be present.
If the water is cloudy, filter it through clean cloths or allow it to settle, and draw off the clear water for boiling.
Boil the water for one minute, let it cool, and store it in clean containers with covers. If you can't boil water, you can disinfect it using household bleach. Bleach will kill some, but not all, types of disease-causing organisms that may be in the water.
If the water is cloudy, filter it through clean cloths or allow it to settle, and draw off the clear water for disinfection.
Add 1/8 teaspoon (or 8 drops) of regular, unscented, liquid household bleach per each gallon of water. Stir it well and let it stand for at least 30 minutes before you use it.
Store disinfected water in clean containers with covers. If you have a well that has been flooded, the water should be tested and disinfected after flood waters recede. If you suspect that your well may be contaminated, contact your local or state health department or agriculture extension agent for specific advice. '
When Flooding Occurs — Keep Food Safe

Follow these steps to keep your FOOD SAFE during — and after — flood conditions.
Do not eat any food that may have come into contact with flood water.
Discard any food that is not in a waterproof container if there is any chance that it has come into contact with flood water.
Food containers that are not waterproof include those with screw-caps, snap lids, pull tops, and crimped caps.
Also, discard cardboard juice/milk/baby formula boxes and home canned foods if they have come in contact with flood water, because they cannot be effectively cleaned and sanitized. Inspect canned foods and discard any food in damaged cans. Can damage is shown by swelling, leakage, punctures, holes, fractures, extensive deep rusting, or crushing/denting severe enough to prevent normal stacking or opening with a manual, wheel-type can opener.
Undamaged, commercially prepared foods in all-metal cans and "retort pouches" (like flexible, shelf-stable juice or seafood pouches) can be saved if you follow this procedure:
Remove the labels, if they are the removable kind, since they can harbor dirt and bacteria.
Brush or wipe away any dirt or silt.
Thoroughly wash the cans or retort pouches with soap and water, using hot water if it is available. Rinse the cans or retort pouches with water that is safe for drinking, if available, since dirt or residual soap will reduce the effectiveness of chlorine sanitation.
Sanitize cans and retort pouches by immersion in one of the two following ways:
Place in water and allow the water to come to a boil and continue boiling for 2 min., or
Place in a freshly-made solution consisting of 1 tablespoon of unscented liquid chlorine bleach per gallon of drinking water (or the cleanest, clearest water available) for 15 minutes. Air dry cans or retort pouches for a minimum of 1 hour before opening or storing.
If the labels were removable, then re-label your cans or retort pouches, including the expiration date (if available), with a marking pen.
Food in reconditioned cans or retort pouches should be used as soon as possible thereafter.
Any concentrated baby formula in reconditioned, all-metal containers must be diluted with clean, drinking water. Thoroughly wash metal pans, ceramic dishes, and utensils (including can openers) with soap and water, using hot water if available. Rinse, and then sanitize them by boiling in clean water or immersing them for 15 minutes in a solution of 1 tablespoon of unscented, liquid chlorine bleach per gallon of drinking water (or the cleanest, clearest water available).
Thoroughly wash countertops with soap and water, using hot water if available. Rinse, and then sanitize by applying a solution of 1 tablespoon of unscented, liquid chlorine bleach per gallon of drinking water (or the cleanest, clearest water available). Allow to air dry.

MULTIPLE SCLEROSIS TREATMENT APPROVED

Photo Credit:  FDA
FROM: U.S. FOOD AND DRUG ADMINISTRATION

FDA approves new multiple sclerosis treatment AubagioThe U.S. Food and Drug Administration today approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS).

"In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. "Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients."

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs at least twice as frequently in women as in men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery periods may be incomplete, leading to progressive decline.

The most common side effects of Aubagio experienced by patients in clinical trials include diarrhea, abnormal liver tests, nausea, and hair loss.

The drug contains a Boxed Warning to alert prescribers and patients to the risk of liver problems, including death, and a risk of birth defects. Physicians should do blood tests to check liver function before a patient starts taking Aubagio and periodically during treatment.

Also included in the Boxed Warning is an alert noting that, based on animal studies, the drug may cause fetal harm. For this reason, Aubagio is labeled as Pregnancy Category X, which means women of childbearing age must have a negative pregnancy test before starting the drug and use effective birth control during treatment.

Aubagio will be dispensed with a patient Medication Guide that provides important instructions on its use and drug safety information.

Aubagio is made by Bridgewater, N.J.-based Sanofi Aventis.

RADIATION AND FULL-BODY SCANNERS

Illustration Credit:  U.S. Transportation Security Administration.

FROM: U.S. FOOD AND DRUG ADMINISTRATION
Very Low Health Risks from Full-Body X-ray Scanners

Be it in airports, court buildings, or other venues, Americans are increasingly encountering full-body imaging systems, the new wave in electronic security screening.

General-use X-ray security screening systems represent one of two full-body scanning technologies currently being put into widespread use to check people for concealed weapons, explosives, or other contraband without having to make physical contact.

Extensive use of full-body scanning technologies, including the general-use X-ray systems, is a relatively new development. Thus it's natural for people to have questions—including questions about whether these systems pose any health risks.

However, FDA Engineer Daniel Kassiday says, "The dose from one screening with a general-use X-ray security screening system is so low that it presents an extremely small risk to any individual."

 
Very Small Amounts of Energy
General-use X-ray security systems found in U.S. airports are also called "backscatter" systems. They use very small amounts of X-ray that are "bounced" off the person being screened. The reflected energy is received by an array of sensitive detectors and then processed by a computer to form an image.

Full-body scanners are large in size, and require individuals to step into the machine and remain still for a few seconds while the scan takes place.

Kassiday explains, "A person receives more radiation from naturally occurring sources in less than an hour of ordinary living than from one screening with any general-use X-ray security system."

The other type of advanced imaging technology being put in general use employs millimeter wave technology. It uses non-ionizing electromagnetic waves to generate an image based on the energy reflected from the body.

FDA scientist Abiy Desta says, "Millimeter wave security systems that comply with the limits set by the Institute of Electrical and Electronics Engineers in the applicable non-ionizing radiation safety standard cause no known adverse health effects."

 
Metal Detectors Still in Use
Meanwhile, people need to be aware that metal detectors are still being used for security screening at many facilities.

Metal detectors, which can be walk-thru portals or hand-held wands, have the potential to affect the function of certain medical devices such as implanted cardiac pacemakers, implantable cardioverter/defibrillators, and spinal cord nerve stimulators.

Although the number of significant injuries due to this is very low, individuals who use an electronic medical device are advised not to stay near a metal detector longer than necessary or lean against the metal-detecting system.

If scanning with a hand-held metal detector is necessary, warn the security personnel that you have an electronic medical device and ask them not to hold the metal detector near the device longer than necessary. You may also ask for an alternate form of personal search.

COMPANY RECALLS ALL 2012 CANTALOUPES BECAUSE OF POSSIBLE SALMONELLA CONTAMINATION

Chamberlain Farm Produce, Inc. Recalls Cantaloupes Because Of Possible Health Risk

FROM: U.S. FOOD AND DRUG ADMINISTRATION

FOR IMMEDIATE RELEASE - August 22, 2012 - Chamberlain Farm Produce, Inc., of Owensville, Indiana, is voluntarily recalling all of its cantaloupes from the 2012 growing season that may remain in the marketplace. This recall is occurring because of concern some cantaloupes may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

This voluntary recall follows a prior voluntary market withdrawal of all Chamberlain Farm Produce, Inc. cantaloupes that occurred August 16 and 17, 2012.

During the period June 21, 2012 to August 16, 2012, Chamberlain Farm Produce, Inc., marketed cantaloupes to four retail grocery stores with grocery store retail outlets in Vanderburgh, Warrick, Gibson, and Dubois County, Indiana, and Wabash County, Illinois; and also to four wholesale purchasers located in Owensboro, Kentucky, St. Louis, Missouri, Peru, Illinois, and Durant, Iowa, respectively. As a part of the voluntary market withdrawal, Chamberlain Farm Produce, Inc. notified all of the purchasers of its cantaloupes to take immediate action to remove all Chamberlain Farm Produce, Inc. cantaloupes from the marketplace, and all of the purchasers confirmed compliance with that request.

The CDC reports that for the period July 7, 2012, through August 22, 2012, there have been reports of some 178 persons nationwide who may have become sick in connection with consumption of cantaloupes. The FDA investigation is ongoing and incomplete at this time. After discussion with the FDA, Chamberlain Farm Produce, Inc., decided to conduct the recall as a precautionary measure.

Consumers should inquire about the source of cantaloupes before purchasing additional cantaloupes or using cantaloupes already purchased. To be absolutely certain, consumers should destroy any cantaloupes currently in their possession the origin of which cannot be identified.

FDA REVIEWS STUDY OF CLASS OF ANTIBACTERIAL DRUGS FOR POSSIBLE RELATIONSHIP WITH CARDIOVASCULAR DEATHS

FROM:  FDA
Audience: Primary Care, Pharmacy
ISSUE: FDA notified healthcare professionals that it is aware of the study published in the New England Journal of Medicine May 17, 2012 reporting a small increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. FDA is reviewing the results from this study and will communicate any new information on azithromycin and this study or the potential risk of QT interval prolongation after the agency has completed its review.

BACKGROUND: Azithromycin belongs to a class of antibacterial drugs called macrolides, which have been associated with cardiovascular effects; specifically, prolongation of the QT interval. In 2011, FDA reviewed macrolide drug labeling information related to QT interval prolongation and TdP. The WARNINGS AND PRECAUTIONS section of the Zmax drug label (azithromycin extended release for oral suspension) was revised in March 2012 to include new information regarding risk for QT interval prolongation, which appears to be low. The drug labels for clarithromycin and erythromycin also contain information about QT interval prolongation in the WARNINGS section. FDA is in the process of updating risk information in the drug labels for additional macrolide antibacterial drugs.

RECOMMENDATION: Patients taking azithromycin should not stop taking their medicine without talking to their healthcare professional. Healthcare professionals should be aware of the potential for QT interval prolongation and heart arrhythmias when prescribing or administering macrolides.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

ABBOT LABS TO PAY $1.5 BILLION IN OFF-LABEL PROMOTIONS SETTLEMENT

FROM:  U.S. DEPARTMENT OF JUSTICE
Monday, May 7, 2012
Abbott Labs to Pay $1.5 Billion to Resolve Criminal & Civil Investigations of Off-label Promotion of DepakoteCompany Maintained Specialized Sales Force to Market Drug for Off Label Purposes; Targeted Elderly Dementia Patients in Nursing Homes

Global Health Care Company Abbott Laboratories Inc. has pleaded guilty and agreed to pay $1.5 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration (FDA), the Justice Department announced today.  The resolution – the second largest payment by a drug company – includes a criminal fine and forfeiture totaling $700 million and civil settlements with the federal government and the states totaling $800 million.  Abbott also will be subject to court-supervised probation and reporting obligations for Abbott’s CEO and Board of Directors.

“Today’s settlement shows further evidence of our deep commitment to public health and our determination to hold accountable those who commit fraud,” said James M. Cole, Deputy Attorney General.  “We are resolute in stopping this type of activity and today’s settlement sends a strong message to other companies.”

The FDA is responsible for approving drugs as safe and effective for specified uses. Under the Food, Drug and Cosmetic Act (FDCA), a company in its application to the FDA must specify each intended use of a drug.  A company’s promotional activities must be limited to only the intended uses that FDA approved.   In fact, promotion by the manufacturer for other uses – known as “off-label” uses – renders the product misbranded.

Abbott has pleaded guilty to misbranding Depakote by promoting the drug to control agitation and aggression in elderly dementia patients and to treat schizophrenia when neither of these uses was FDA approved.   In an agreed statement of facts filed in the criminal action, Abbott admits that from 1998 through 2006, the company maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use.   In addition, from 2001 through 2006, the company marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after its clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use.
         
Illegal Promotion of Depakote to Control Agitation and Aggression in Dementia Patients
       The FDA approved Depakote for only three uses: epileptic seizures, bipolar mania and the prevention of migraines.  The FDA never approved the drug as safe and effective for the off-label use of controlling behavioral disturbances in dementia patients.  In 1999, Abbott was forced to discontinue a clinical trial of Depakote in the treatment of dementia due to an increased incidence of adverse events, including somnolence, dehydration and anorexia experienced by the elderly study participants administered Depakote.
Abbott trained its sales force to promote Depakote to health care providers and employees of nursing homes as advantageous over antipsychotic drugs for controlling agitation and aggression in elderly dementia patients because Depakote was not subject to certain provisions of the Omnibus Budget Reconciliation Act of 1987 (OBRA) and its implementing regulations designed to prevent the use of unnecessary medications in nursing homes.   Exploiting the fact that certain OBRA provisions did not yet apply to Depakote, Abbott sales representatives stated that by using Depakote, nursing homes could avoid the administrative burdens and costs of complying with OBRA.

Abbott’s off-label promotion of Depakote was multifaceted.   The company entered into contracts that provided long-term care pharmacy providers with payments of rebates based on increases in the use of Depakote in nursing homes serviced by the providers.   In addition to using its sales force to promote the drug to health care providers and employees of nursing homes, Abbott created programs and materials to train the pharmacy providers’ consultant pharmacists about the off-label use of Depakote to encourage them to recommend the drug for this unapproved use.   Under these contracts, Abbott paid millions of dollars in rebates to the pharmacy providers.

 “Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and downplayed the risks apparent from its own clinical studies,” said Acting Associate Attorney General Tony West.  “As this criminal and civil resolution demonstrates, those who put profits ahead of patients will pay a hefty price.”

Illegal Off-Label Promotion of Depakote for Schizophrenia
In the agreed statement of facts, Abbott also admitted that from 2001 through 2006, the Company misbranded Depakote by marketing the drug to treat schizophrenia.  Abbott funded two studies of the use of Depakote to treat schizophrenia, and both failed to meet the main goals established for the study.  When the second study failed to show a statistically significant treatment difference between antipsychotic drugs used in combination with Depakote and antipsychotic drugs alone, Abbott waited nearly two years to notify its own sales force about the study results and another two years to publish those results.  During this time, Abbott continued to promote Depakote off-label to treat schizophrenia.

 “ Today’s settlement demonstrates our continued scrutiny of the sales and marketing practices of pharmaceutical companies that put profits ahead of patient health,” said U.S. Food and Drug Administration Commissioner Margaret Hamburg, M.D.  “The FDA will continue its due diligence and hold pharmaceutical companies accountable for marketing practices that undermine the drug approval process.”

Criminal Plea
Today’s global resolution has criminal, civil and administrative components.   First, Abbott has pleaded guilty to a criminal misdemeanor for misbranding Depakote in violation of the FDCA.  Under the plea agreement, Abbott will pay a criminal fine of $500 million, forfeit assets of $198.5 million, and submit to a term of probation for five years.   In addition, Abbott will also pay $1.5 million to the Virginia Medicaid Fraud Control Unit.   As a condition of probation, Abbott will report any probable FDCA violations to the probation office, its CEO will certify compliance with this reporting requirement, and its board will report annually on the effectiveness of the company’s compliance program.   In addition, Abbott agrees that during the term of probation, the company will not compensate sales representatives for off-label sales, will ensure that continuing medical education grant-making decisions are not controlled by sales and marketing, will require that letters communicating medical information to healthcare providers be accurate and unbiased, and will have policies designed to ensure that clinical trials are approved by the company’s medical or scientific organizations and published in a consistent and transparent manner.   Abbott’s guilty plea and sentence are not final until accepted by the U.S. District Court for the Western District of Virginia.

“As the agreed statement of facts filed in court today demonstrates, Abbott promoted Depakote to control behaviors in elderly dementia and schizophrenia patients without significant evidence of its effectiveness for that use, and even after clinical data established that it was not effective,” said Timothy Heaphy, U.S. Attorney for the Western District of Virginia.   “The resolution announced today includes a self-policing mechanism by which Abbott’s board of directors will monitor compliance with the law and report any violations, as well as a period of probation and court supervision.   We credit Abbott’s acceptance of responsibility and encourage other pharmaceutical companies to impose the similar mechanisms to prevent off-label marketing, which damages health care consumers.”

Civil Settlement 
Under the civil settlement, Abbott has agreed to pay $800 million to the federal government ($560,851,357) and the states ($239,148,643) that opt to participate in the agreement to resolve claims that its unlawful marketing and illegal remuneration practices caused false claims to be submitted to government health care programs such as Medicare, Medicaid, TRICARE and to the Federal Employees Health Benefit Program, the Department of Veterans’ Affairs and the Department of Labor’s Office of Workers’ Compensation Programs.

The civil settlement addresses broader allegations by the United States that from 1998 through 2008, Abbott unlawfully promoted Depakote for unapproved uses, including behavioral disturbances in dementia patients, psychiatric conditions in children and adolescents, schizophrenia, depression, anxiety, conduct disorders, obsessive-compulsive disorder, post-traumatic stress disorder, alcohol and drug withdrawal, attention deficit disorder and autism.   .  Some of these unapproved uses were not medically accepted indications for which the United States and state Medicaid programs provided coverage for Depakote.  The United States contends that this promotion included, in part, making false and misleading statements about the safety, efficacy, dosing and cost-effectiveness of Depakote for some of these unapproved uses, and claiming use of Depakote to control behavioral disturbances in dementia patients would help nursing homes avoid the administrative burdens and costs of complying with OBRA regulatory restrictions applicable to antipsychotics.

The civil settlement also covers allegations that Abbott offered and paid illegal remuneration to health care professionals and long term care pharmacy providers to induce them to promote and/or prescribe Depakote and to improperly and unduly influence the content of company sponsored Continuing Medical Education programs, in violation of the Federal Anti-Kickback Statute.   The claims settled by the civil agreement are allegations only and there has been no determination of liability, except to the extent that Abbott has admitted facts in the civil settlement agreement or in the criminal plea and agreed statement of facts filed in the criminal action.

The civil settlement resolves four lawsuits pending in federal court in the Western District of Virginia under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery. As part of today’s resolution, the whistleblowers will receive $84 million from the federal share of the settlement amount.

Corporate Integrity Agreement

In addition to the criminal and civil resolutions, Abbott has also executed a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services, Office of Inspector General (HHS-OIG).   The five-year CIA requires, among other things, that Abbott's board of directors review the effectiveness of the company's compliance program, that high-level executives certify to compliance, that Abbott maintain standardized risk assessment and mitigation processes, and that the company post on its website information about payments to doctors.   Abbott is subject to exclusion from federal health care programs, including Medicare and Medicaid, for a material breach of the CIA and subject to monetary penalties for less significant breaches.

 “As a result of OIG’s joint investigation with our federal and state partners, Abbott Laboratories will enter one of the pharmaceutical industry’s largest settlements and pay $1.5 billion for unlawfully promoting its drug Depakote, including to nursing home patients with dementia,” said HHS Inspector General Daniel R. Levinson.  “Our integrity agreement will hold Abbott accountable for preventing future violations of federal health care laws and FDA requirements, which will protect federal programs, taxpayers and our most vulnerable patients.”

A Multilateral Effort 
The criminal case is being prosecuted by the U.S. Attorney’s Office for the Western District of Virginia and the Civil Division’s Consumer Protection Branch.   The civil settlement was reached by the U.S. Attorney’s Office for the Western District of Virginia and the Civil Division’s Commercial Litigation Branch.   Assistance w as provided by representatives of the HHS Office of Counsel to the Inspector General; the Center for Medicare and Medicaid Services (CMS) and Office of the General Counsel, CMS Division; FDA’s Office of Chief Counsel; and the National Association of Medicaid Fraud Control Units.

 “Crimes involving the misbranding of drugs for financial gain will not be tolerated,” stated Richard Weber, Chief IRS Criminal Investigation.  “The special agents of IRS Criminal Investigation will use all their investigative tools, including the use of asset forfeiture statutes, to combat financial crimes and hold corporations accountable for their actions.”

This matter was investigated by the Virginia Attorney General’s Medicaid Fraud Control Unit; the Internal Revenue Service - Criminal Investigation; the FDA - Office of Criminal Investigation; the Defense Criminal Investigative Service; the Health and Human Services - Office of Inspector General; the West Virginia State Police; the Office of Personnel Management - Office of Inspector General; the Department of Veterans’ Affairs Office of Inspector General; the Department of Labor - Office of Inspector General; and TRICARE Program Integrity.

This resolution is part of the government's emphasis on combating health care fraud and another step for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Kathleen Sebelius, Secretary of HHS.  The partnership between the two departments has focused efforts to reduce and prevent Medicare and Medicaid financial fraud through enhanced cooperation.  One of the most powerful tools in that effort is the False Claims Act, which the Justice Department has used to recover more than $7.4 billion since January 2009 in cases involving fraud against federal health care programs.  With the settlement announced today, the Justice Department's total recoveries in False Claims Act cases since January 2009 will exceed $10.2 billion.   During this same time, the department has secured $3.9 billion in criminal fines, forfeiture, disgorgement, and restitution relating to violations of the FDCA.