This is not the first time the FDA has offered some tough talk. The latest warning, however, comes from FDA deputy chief for litigation Eric Blumberg, who spoke at an industry conference yesterday and reiterated agency interest in targeting pharma execs for misdemeanor prosecutions if their companies engage in off-label marketing.
His remarks come amid growing complaints that the large fines paid and corporate integrity agreements signed by drugmakers to settle such charges are, essentially, viewed as a cost of doing business and that few, if any, individuals with sweeping corporate authority are held accountable. Among the drugmakers that have settled are Pfizer, Eli Lilly, Johnson & Johnson, AstraZeneca, Bristol-Myers Squibb, Allergan, Forest Laboratories and Novartis.
“It’s clear we’re not getting the job done with large, monetary settlements,” Blumberg told the conference, according to Bloomberg News. “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...If you’re a corporate executive or are advising a corporate executive, now is the time to comply. That conduct may already be under the criminal microscope.”
What's at stake? An exec could face up to $100,000 in fines and one year in jail (shareholders may object the employer pays for legal representation, but that is a separate matter). The FDA also can bar individuals from working in the industry. Last March, the FDA indicated it would pursue misdemeanor charges (back story), most likely by using a legal tool known as the Park Doctrine, which the agency last used more than a decade ago to press felony charges.
The emphasis on prosecution also comes as the Health and Human Services Office of Inspector General pushes for measures that would make it possible to ban pharma execs from doing business with federal health programs, such as Medicare and Medicaid, if their companies have been convicted of fraud. The House, in fact, recently passed a bill toward that end (see here).