FDA to Wield New Weapon in Fight Against Off-Label Drug Marketing

The Food & Drug Administration (FDA) is showing an increasing willingness to bring criminal charges against drug company executives in a quest to the corporate culture of an industry that seems to be immune to billion-dollar fines. According to the Philadelphia Inquirer, the FDA has let it be known that it is looking for cases to use the so-called “Park Doctrine” against executives whose firms have <"http://www.yourlawyer.com/practice_areas/defective_drugs">illegally promoted drugs for unapproved uses.

Prescribing a drug for an unapproved use – something known as off-label use – is legal. But promoting such uses is not. Traditionally, the FDA has sought monetary penalties against drug makers that engage in such marketing. Last year, for instance, Eli Lilly was hit with a $1.4 billion fine for illegally marketing Zyprexa. The same year, Pfizer was fined $2.3 billion for illegally marketing the pain reliever Bextra.

Unfortunately, such fines have proven ineffective in dissuading drug makers from engaging in off-label marking. So enter the Park Doctrine, by which a corporate officer is liable for illegal corporate actions the officer should have known about or was responsible for preventing. According to the Inquirer, the doctrine is named for John Park, president of Acme Markets Inc., a firm cited in 1970 for rodent infestations at a Philadelphia warehouse. Park was personally charged with violating sanitation laws after other rodent infestations were discovered despite a number of agency warnings. The case made it all the way to the US Supreme Court, with the high court siding with the FDA.

According to the Philadelphia Inquirer, Eric Blumberg, FDA litigation chief, told an industry audience earlier this month that the agency was looking to wield the Park Doctrine against executives when their companies promote off-label uses of drugs.

“I don’t know when, where, or how many cases will be brought,” Blumberg told a gathering of the Food and Drug Law Institute, “but if you are a corporate executive – or counsel advising such a client – I would not wait for the first case to decide now is the time to comply with the law. They won’t get a mulligan on their conduct.”

According to the Philadelphia Inquirer, the FDA will seek up to a year in prison and $100,000 fines for drug company executives prosecuted under the Park Doctrine.

Many industry insiders seem to appreciate that the FDA is serious, with one pharmaceutical consultant telling the Inquirer that the agency’s tough talk has caught the attention of Big Pharma. The same consultant said the filing of a significant Park Doctrine case involving off-label marketing – something he expects to happen within six months – will bring even more notice.

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