US government officials tell FDLI conference that more people will be convicted of crimes under FDA laws

A number of US government officials unanimously predicted a dramatic increase in the number of criminal prosecutions of individuals for violations of laws governing Food and Drug Administration-regulated industries, at a recent Food and Drug Law Institute (FDLI) conference held in Washington DC.

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, reported Douglas Farquhar of law firm Hyman, Phelps & McNamara - who co-chaired the conference - on the firm’s FDA Law Blog.

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).