Does FDA’s Per Se Prohibition Against Off-Label Promotion Have a Future?

April 26, 2016
Does FDA’s Per Se Prohibition Against Off-Label Promotion Have a Future?

The short answer to that question is “No,” says Hyman, Phelps & McNamara, P.C.’s Jeffrey K. Shapiro in an article published in the March/April 2016 issue of the Food and Drug Law Institute’s Update Magazine. Mr. Shapiro examines the Department of Justice’s recent criminal prosecution of Vascular Solutions, Inc. (“VSI”), which ended with a unanimous jury acquittal for VSI and its chief executive officer of, among other things, misbranding products due to off-label promotion.

“[Z]ombielike, FDA/DOJ continue to pursue truthful and non-misleading off-label promotion as if it were per se a crime,” writes Mr. Shapiro. “Absent an unlikely U-turn at the Supreme Court, the federal courts likely will continue to find that FDA’s prohibition against truthful and non-misleading off-label promotion is inconsistent with the First Amendment. However, FDA’s Warning Letters and DOJ enforcement actions could continue for years before enough case law accumulates to force real change, with some companies and individuals choosing to settle rather than risk overwhelming punishment.”