The FDA is taking its off-label marketing debate public. After an onslaught of lawsuits and citizen petitions against drug-marketing restrictions--all citing the First Amendment--the agency will hold a public meeting this summer to talk about off-label promos and free speech, Reuters reports.
In recent months, the agency has shown a new willingness to consider the free speech argument, thanks to an appeals court ruling that appears to favor pharma's case. But this is the first time the FDA will take up the issue in a public forum--and drugmakers will be lining up experts to weigh in.
The debate has been brewing for several years now, as drugmakers challenged the FDA's right to police off-label promotions in court and via the agency's own administrative channels. Top drugmakers challenged the agency's off-label regulations way back in 2011, demanding clarity about what they could and couldn't say about unapproved drug uses.
But the fight heated up in 2012, when the 2nd Circuit Court of Appeals ruled that an individual sales rep's off-label promotions--if true and non-misleading--were protected by the First Amendment. The U.S. v. Caronia ruling said this loud and clear: "The government cannot prosecute pharmaceutical manufacturers ... for speech promoting the lawful, off-label use of an FDA-approved drug."
Big Pharma and Big Biotech stepped up the pressure, and as Reuters reports, companies including Novartis ($NVS), Eli Lilly ($LLY), GlaxoSmithKline ($GSK) and Sanofi ($SNY) petitioned the FDA to "adequately justify and appropriately tailor its regulatory regime," considering Caronia and other free-speech rulings.
But pharma won't go unchallenged. In March, critics blasted an FDA proposal that would allow drugmakers to hand out published journal articles about off-label uses of their meds. Public Citizen and other watchdogs sent in their criticisms as part of a public comment period on that proposal.
- read the Reuters news