by Brian Malkin and Laura Fanelli
In just the past two weeks, FDA declared tighter controls on a popular anti-diabetes drug, admonished the makers of popular mouthwash products for misleading advertisements, commented on the debatable issue of genetically-engineered salmon, continued investigations into the biggest recalls in history of children's pediatric medications and contaminated eggs, cautioned consumers about the possibility that devices purportedly offering protection against Sudden Infant Death Syndrome could themselves be lethal, and announced that Meridia® (sibutramine), an anti-obesity drug, was being pulled from the market.
FDA's flurry of enforcement activity appears to be the result of a new regulatory activism that will likely continue as the Obama Administration attempts to advance its agenda through Executive Orders instead of through Congress. FDA's Center for Drug Evaluation and Research issued 103 warning letters in 2009 for misleading labeling and other violations. This number represents a drastic increase from the mere 21 warning letters issued in 2006. "I think the general approach has clearly been more warning letters, more regulatory activity, a much more rigorous approach to regulating products on the market," said Kenneth Kaitin, Director of the Tufts Center for the Study of Drug Development, a nonprofit research institute, as reported by Andrew Zajac, Tribune Washington Bureau, for the Los Angeles Tribune.
FDA's recent activism may also mean potential misdemeanor charges against pharmaceutical executives. FDA Deputy Chief for Litigation, Eric "Rick" Blumberg, announced that FDA is considering bringing a misdemeanor charge against industry executives whose companies promote unauthorized, or "off-label," uses of their medicines. "Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion," said Blumberg, as reported by Anna Edney for Bloomberg.
Misdemeanor prosecutions of executives for violations of the federal Food, Drug, and Cosmetic Act fall under the Park Doctrine, which has not been widely used for drug industry cases in the past two decades. Executives could face as much as $100,000 fines and one year in prison. In addition, FDA can bar individuals from working in the drug industry. Blumberg said that industry executives should not wait until the first charges are brought to bring their marketing in compliance. He cautioned, "if you're a corporate executive or are advising a corporate executive, now is the time to comply."