Ed Silverman asks

Will A Court Ruling Usher In Off-Label Promotions?


A recent US appeals court ruling that pitted free speech rights versus off-label promotion of pharmaceuticals has raised speculation that 2013 may usher in the sort of aggressive marketing by drug makers that has previously drawn the wrath of federal prosecutors. But such a sudden shift in promotional efforts is unlikely, at least until the dispute has finished winding its way through the courts.

The case involved a former sales representative who worked for what is now Jazz Pharmaceuticals and marketed a drug for a form of narcolepsy. The rep was convicted in 2008 of a misdemeanor for encouraging doctors to prescribe the medication for unapproved uses, but successfully argued that his First Amendment rights were violated because his promotional remarks were not false or misleading (back story with indictment, lawsuit and ruling is here).

And so the ruling – which was actually a 2-to-1 vote made by a three-person panel – has prompted debate about whether the pharmaceutical industry is poised to pursue a more aggressive form of off-label marketing and the extent to which the federal government will continue to press cases against drug makers for marketing medications for unapproved uses.

The interim nature of the situation, however, suggests the industry will take a cautious approach before altering its marketing strategy. The FDA, for instance, may seek a rehearing before the entire court and, even then, the issue may work its way to the US Supreme Court. Also, the recent ruling pertains to just one circuit covering three states, so the FDA, notes former FDA and Pfizer attorney Arnie Friede, can meanwhile pursue violations elsewhere (read more here).

As for the US Department of Justice, the ruling clearly noted that free speech rights do not extend to instances where information is false and misleading. But such violations have always provided needed grist for prosecution and many of the settlements with drug makers in recent years, such as with Pfizer, Eli Lilly and GlaxoSmithKline, notes Stephen Sheller, an attorney who has represented whistleblowers.

This suggests that prosecutors will continue to bring such cases. But of course, if the recent ruling does eventually stand, then drug makers will one day have a significant opportunity to generate countless new prescriptions and, consequently, boost revenue, even as the scope of ‘false and misleading’ is given still greater scrutiny.

http://www.forbes.com/sites/edsilverman/2012/12/31/will-a-court-ruling-usher-in-off-label-promotions/?