Watch Out! At FDLI Conference, Government Says More People Will Be Convicted of Crimes

By Douglas B. Farquhar – 

At a trade industry conference this week, a cadre of government officials unanimously predicted a dramatic increase in the number of criminal prosecutions of individuals for violations of laws governing FDA-regulated industries.  They also discussed how the types of prosecutions may be shifting away from charges based on off-label promotion of drugs and medical devices to charges based on threats to the safety and efficacy of FDA-regulated products, which include food, tobacco, medical devices, and drugs.

I was a co-chair of the conference, which was sponsored by the Food and Drug Law Institute (“FDLI”) in Washington, D.C., along with Jennifer Bragg of the law firm Skadden, Arps, Slate, Meager & Flom.  The Annual FDLI Enforcement Conference gathers together as speakers the decision-makers on enforcement and compliance from all of the major Centers at FDA (Food, Medical Devices, Advertising and Promotion, Drugs, Veterinary Drugs, and Biologics), the top enforcement officer for the agency (Eric Blumberg, FDA Deputy Chief Counsel for Litigation) and the head of the Office of Consumer Litigation, the litigating arm for FDA at the federal Department of Justice (Eugene Thirolf).

In what was probably the most concentrated collection of enforcement speakers gathered at an industry event, nearly all of the speakers predicted an increase in the number of prosecutions of individuals for violations of the Federal Food, Drug, and Cosmetic Act, the statute that governs manufacture and distribution of FDA-regulated products.  The Conference focused on strict-liability prosecutions under the so-called Park doctrine (also covered in an HPM-sponsored webinar last week), and the officials predicted an increase of prosecutions of responsible corporate officials, even if there is no proof that they participated in, encouraged, or even had knowledge of the violations.  Speakers from the government, industry, and private law firms (that would include yours truly) discussed how it is imperative that top corporate officials implement policies and procedures that effectively prevent violations from occurring, with a special emphasis on ensuring that no unapproved claims are made in promotional materials for drugs and devices, that reports of safety problems are filed with FDA promptly and accurately, that officials do not ignore problems discovered in testing of manufactured products, and that drugs and devices are manufactured in accordance with regulations setting current Good Manufacturing Practice.

The trade press has already reported that the government may especially be looking at prosecuting officials for off-label promotion because they feel that the huge monetary settlements with drug and device companies (reportedly more than $9 billion in the last ten years) are not getting the job done.

In addition:

• Blumberg indicated that he expects that criminal investigations will focus on distribution of unapproved new drugs, failure to report unexpected adverse events caused by medical products, and “flagrant” off-label promotion (that is, advertising, company-sponsored programs, pitches by sales reps, and other promotional material which encourages the use of the products for conditions or treatments other than those approved in the labeling).
• Each of the FDA Center compliance directors reported that they are cooperating much more closely with FDA’s Office of Criminal Investigations.
• Howard Sklamberg, Director of FDA’s Office of Enforcement, noted that Class I recalls (the most serious category of recalls) will generally lead to increased FDA inspections and scrutiny of an FDA-regulated company.
• Thirolf mentioned that he anticipates seeing more criminal investigations and prosecutions focused on safety issues, rather than just off-label promotions.  He confirmed, in response to a particularly astute question (that would be from me) that safety issues include distribution of defective products, failure to report adverse events, and fraudulent reporting of testing data or false documentation of manufacturing processes and procedures.

One of the speakers also said that there were 70 whistleblower cases that were filed last year against device and drug companies that are currently being investigated by the federal government.

For more information about the conference, or to get a copy of a CD audio recording of the proceedings, visit www.fdli.org.