FDA Compliance Directors and Others Predict Where the FDA Spotlight Will Shine

By Douglas B. Farquhar –

At the FDA Enforcement and Litigation Conference sponsored by the Food and Drug Law Institute ("FDLI"), the Compliance Directors of three of FDA's Centers, representatives of other components of the Food and Drug Administration, and a Justice Department official today forecast where FDA will concentrate its enforcement efforts under the new FDA Commissioner, Dr. Margaret Hamburg.

Aside from discussing Commissioner Hamburg’s initiatives, announced in a speech before FDLI on August 6, 2009, the common threads announced by the Compliance Directors were that FDA inspections and compliance efforts will be risk-based, meaning that the agency will focus on inspecting firms and products that have histories of noncompliance and where problems with the products could cause serious health consequences for consumers.  The Compliance Directors also emphasized the use of concentrated enforcement techniques to block imports of violative products from overseas, using, especially, Import Alerts, a technique which permits the agency, in cooperation with the United States Customs and Border Protection, to block products from entering the country without any prior involvement of a court or the United States Department of Justice.

More specifically,

• Gene Thirolf, the Director of the Office of Consumer Litigation (the branch of the Department of Justice responsible for prosecuting violations of the Federal Food, Drug, and Cosmetic Act), announced that False Claims Act cases, he expects, will begin to be filed and pursued against drug companies for manufacturing drugs that do not comply with relevant manufacturing specifications, and for distributing drugs when the companies have failed to report adverse events which have occurred with their drugs.  As Mr. Thirolf stated, False Claims Acts cases, which have resulted in recoveries for the government in numerous cases in the hundreds of millions of dollars, and in two recent cases, in billions of dollars, have traditionally been brought for drugs which were marketed using off-label claims or where there were allegations relating to kickbacks for doctors to encourage them to prescribe products, although some cases have already been brought under the False Claims Act for failure to report adverse events.  The discussion indicates that the Department of Justice will likely continue to broaden the scope of these types of claims.  The False Claims Act enables the federal government, in claims either brought with or without whistleblowers, to secure multiple damages and large penalties for claims submitted to the government for products on the basis of false statements. 

• Deborah Autor, the Director of Compliance at FDA’s Center for Drug Evaluation and Research, stated that her office is also looking at a firm's overall ability to meet FDA requirements as a possible indicator of whether the firm should be a compliance concern.  For example, she said that her office is noticing that poor quality of applications for FDA approval of drugs or faulty Adverse Event Report systems tend to show a likelihood of poor compliance in other areas, such as cGMP (current Good Manufacturing Practice). 

• Roberta Wagner, the Director of Compliance at FDA's Center for Food Safety and Applied Nutrition, indicated that her office is now sending requests to FDA District Offices to inspect specific food establishments, instead of leaving to the District Offices’ discretion which companies to inspect.  She said that her Center is basing its identification of companies on the degree of risk posed by the companies due to type of product, compliance history,  and health risk caused by violative products.

• Tom Abrams, the Director of DDMAC (FDA’s Division of Drug Marketing, Advertising and Communications), emphasized that there will be a series of hearings in early November on how FDA should regulate the use of social media (such as YouTube, Twitter, Facebook) in drug marketing.  This announcement follows on the heels of new Guidelines issued by the Federal Trade Commission just last week on a similar subject.

• Tim Ulatowski, the Director of Compliance for FDA’s Center for Devices and Radiological Health, pointed to a recently issued guidance on the registration of device companies.

• Dan McChesney, Director of Compliance at FDA’s Center for Veterinary Medicine, indicated the Center will focus on drug compounding establishments.

More information about the conference is available through FDLI.

Doug Farquhar co-chairs the FDLI Enforcement and Litigation Conference.