FDA officials say they're 'serious' about pharma's free speech

FDA CDER Director Janet Woodcock

FDA officials are having a rethink on free speech--and that could end with an about-face on off-label marketing.

What with key court decisions apparently backing First Amendment protections for drug promotions, the FDA has moved off-label communications to the top of its to-do list, officials said at a recent FDA law conference. And off-label marketing is a hot-button issue, what with the series of multibillion-dollar settlements with the U.S. Justice Department.

"[T]he agency is taking these first amendment concerns very seriously," said Elizabeth Dickinson, the FDA's chief counsel. "We are currently carefully evaluating our policies in light of court decisions on first amendment issues," said Center for Drug Evaluation and Research chief Janet Woodcock.

The upshot? Officials are looking to "realign FDA regulatory posture in this area" and have taken "a number of steps to start down this road," said Leslie Kux, FDA assistant commissioner for policy. Read more at FiercePharmaMarketing >>