COMPANY MARKETING MYCAMINE WILL PAY$7.3 MILLION TO RESOLVE ALLEGATIONS OF FALSE CLAIMS ACT VIOLATION

FROM:  U.S. JUSTICE DEPARTMENT 

Wednesday, April 16, 2014

Astellas Pharma US Inc. to Pay $7.3 Million to Resolve False Claims Act Allegations Relating to Marketing of Drug Mycamine

Pharmaceutical company Astellas Pharma US Inc. will pay $7.3 million to resolve allegations that it violated the False Claims Act in connection with its marketing and promotion of the drug Mycamine for pediatric use, the Justice Department announced today.  Astellas Pharma US Inc., located in Northbrook, Ill., manufactures and sells pharmaceutical drugs, including Mycamine.

“The FDA’s drug approval process requires companies to demonstrate the safety and efficacy of their products,” said Assistant Attorney General for the Justice Department’s Civil Division Stuart F. Delery.  “The Justice Department will hold accountable pharmaceutical companies that skirt these rules and seek to bill federal health care programs for uses of drugs that are not reimbursable.”

The settlement resolves allegations that, between 2005 and 2010, Astellas knowingly marketed and promoted the sale of Mycamine for pediatric use, which was not a medically accepted indication and, therefore, not covered by federal health care programs.  During this time period, the FDA approved Mycamine to treat adult patients suffering from serious and invasive infections caused by the fungus Candida, including infections in the esophagus, the blood and the abdomen, and to prevent Candida infections in adults undergoing stem cell transplants.  From 2005 through June 2013, however, Mycamine was not approved to treat pediatric patients for any use.      

As a result of today’s $7.3 million settlement, the federal government will receive $4.2 million, and state Medicaid programs will receive $3.1 million.

“The settlement in this case further demonstrates our commitment to hold responsible any pharmaceutical company that disregards the FDA drug approval process and promotes drugs for uses before they have been deemed safe and effective,” said U.S. Attorney for the Eastern District of Pennsylvania Zane David Memeger.  “It’s a message that should resonate with all drug companies: there are consequences for violating the False Claims Act and putting profit ahead of government safeguards.”

The allegations resolved by the settlement arose from a lawsuit filed by Frank Smith, a former Astellas sales representative, under the False Claims Act’s whistleblower provisions, which permit private parties to sue for false claims on behalf of the government and to share in any recovery.  Smith will receive $708,852.  

This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which was announced in May 2009 by Attorney General Eric Holder and Secretary of Health and Human Services Kathleen Sebelius.  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 this effort is the False Claims Act.  Since January 2009, the Justice Department has recovered a total of more than $19.1 billion through False Claims Act cases, with more than $13.6 billion of that amount recovered in cases involving fraud against federal health care programs.

This case was a cooperative effort among the U.S. Attorney’s Office for the Eastern District of Pennsylvania, the Civil Division of the Department of Justice and the Offices of the Inspectors General of the Department of Health and Human Services and Office of Personnel Management.  The lawsuit is captioned United States ex rel. Smith v. Astellas Pharma, US Inc. et al., No. 10-999 (E.D. Pa.).

The claims resolved by the settlement are allegations only; there has been no determination of liability.

FDA QUESTIONS SAFETY, EFFECTIVENESS OF ANTIBACTERIAL SOAPS

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 
FDA NEWS RELEASE
FDA issues proposed rule to determine safety and effectiveness of antibacterial soaps
The U.S. Food and Drug Administration today issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market.

Today’s action is part of a larger, ongoing review of antibacterial active ingredients by the FDA to ensure these ingredients are proven to be safe and effective. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.

Millions of Americans use antibacterial hand soap and body wash products. Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water. Further, some data suggest that long-term exposure to certain active ingredients used in antibacterial products—for example, triclosan (liquid soaps) and triclocarban (bar soaps)—could pose health risks, such as bacterial resistance or hormonal effects.

“Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”

The widespread consumer use of antibacterial products, the accumulated scientific information and concerns raised by health care and consumer groups have prompted the FDA to reevaluate what data are needed to classify the active ingredients in consumer antibacterial products as “generally recognized as safe and effective” or GRASE.  Under the proposed rule, manufacturers who want to continue marketing antibacterial products will be required to provide the agency with additional data on the products’ safety and effectiveness, including data from clinical studies to demonstrate that these products are superior to non-antibacterial soaps in preventing human illness or reducing infection.

“While the FDA continues to collect additional information on antibacterial hand soaps and body washes, we encourage consumers to make an educated choice about what products they choose to use,” said Sandra Kweder, M.D., deputy director, Office of New Drugs at CDER. “Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others.”

Consumers should continue to be diligent about washing their hands. If soap and water are not available, an alcohol-based hand sanitizer that contains at least 60 percent alcohol should be used.  More information on appropriate hand washing from the CDC may be found here.

Almost all soaps labeled “antibacterial” or “antimicrobial” contain at least one of the antibacterial ingredients addressed in the proposed rule. The most common active ingredients in antibacterial soaps are triclosan and triclocarban. Some soaps labeled “deodorant” may also contain these ingredients.

The proposed rule does not require the antibacterial soap products to be removed from the market at this time. When the proposed rule is finalized, as previously stated, either companies will have provided data to support an antibacterial claim, or if not, they will have to reformulate (remove antibacterial active ingredients) or relabel (remove the antibacterial claim from the product's labeling) these products in order to continue marketing. The proposed rule is available for public comment for 180 days, with a concurrent one year period for companies to submit new data and information, followed by a 60-day rebuttal comment period.

CDC SAYS E-CIGARETTES, HOOKAHS GAINING POPULARITY WITH STUDENTS

FROM:  CENTERS FOR DISEASE CONTROL AND PREVENTION
Press Release Emerging tobacco products gaining popularity among youth
Increases in e-cigarette and hookah use show need for increased monitoring and prevention

Emerging tobacco products such as e-cigarettes and hookahs are quickly gaining popularity among middle- and high-school students, according to a report in this week’s Morbidity and Mortality Weekly Report.

While use of these newer products increased, there was no significant decline in students’ cigarette smoking or overall tobacco use. Data from the 2012 National Youth Tobacco Survey (NYTS) show that recent electronic cigarette use rose among middle school students from 0.6 percent in 2011 to 1.1 percent in 2012 and among high school students from 1.5 percent to 2.8 percent. Hookah use among high school students rose from 4.1 percent to 5.4 percent from 2011 to 2012.

The report notes that the increase in the use of electronic cigarettes and hookahs could be due to an increase in marketing, availability, and visibility of these tobacco products and the perception that they may be safer alternatives to cigarettes. Electronic cigarettes, hookahs, cigars and certain other new types of tobacco products are not currently subject to FDA regulation. FDA has stated it intends to issue a proposed rule that would deem products meeting the statutory definition of a "tobacco product" to be subject to the Federal Food, Drug, and Cosmetic Act.

Another area of concern in the report is the increase in cigar use among certain groups of middle and high school students. During 2011-2012, cigar use increased dramatically among non-Hispanic black high school students from 11.7 percent to 16.7 percent, and has more than doubled since 2009. Further, cigar use among high school males in 2012 was 16.7 percent, similar to cigarette use among high school males (16.3 percent).

“This report raises a red flag about newer tobacco products,” said CDC Director Tom Frieden, M.D., M.P.H. “Cigars and hookah tobacco are smoked tobacco – addictive and deadly. We need effective action to protect our kids from addiction to nicotine.”