Federal Court Says Drug Promotion Is Free Speech

The Federal Court of Appeals for Second Circuit gave new life to a decades-long debate on First Amendment limits to FDA power. The case concerns the off-label promotion of drugs. Off-label use of drugs is a legal and integral part of modern medicine. It is particularly common in oncology, pediatric, and geriatric populations. Many off-label uses are medically accepted and covered by insurance. Though doctors can prescribe off-label uses, and researchers can study off-label uses and publish the results of clinical trials, pharmaceutical companies can’t promote off-label uses – without violating FDA regulations.

The ruling changes the status quo for the Second Circuit. The court said, “The government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA [Food Drug & Cosmetic Act] for speech promoting the lawful, off-label use of an FDA-approved drug.” The dissenting judge, Judge Debra Ann Livingston, contended, “The majority calls into question the very foundations of our century-old system of drug regulation.” She argued that if drug companies “were allowed to promote FDA-approved drugs for non-approved uses, they would have little incentive to seek FDA approval for those uses.”

This ruling is a big deal, even though nothing much will change right away because the ruling only applies in the Second Circuit (New York, Vermont, and Connecticut). But the government is likely to appeal and the case could easily find its way to the Supreme Court.

It has the potential to dramatically change the rules for pharmaceutical companies, creating big opportunities as well as big risks. The risks come because misleading or false claims are not protected. So an off-label use that’s accepted one day can later fall out of favor when new studies emerge. And that opens a company to liability for false claims, with the benefit of 20/20 hindsight.

Click here to read more in the New York Times and here to read the ruling and the dissent.