WASHINGTON, D.C., Dec. 4, 2012 – The Competitive Enterprise Institute applauded the U.S. Second Circuit Court of Appeals decision yesterday, concluding that the Food and Drug Administration cannot forbid pharmaceutical manufacturers from engaging in truthful and non-misleading speech about their products.
In a long awaited decision, the New York-based federal court overturned the conviction of drug sales representative Alfred Caronia for telling a physician about safe and effective, but unapproved uses for one of his company’s drugs. The judges explained that, “[s]peech in aid of pharmaceutical marketing … is a form of expression protected by the Free Speech Clause of the First Amendment,” but “the government clearly prosecuted Caronia for his words – for his speech.”
“The prosecutors never claimed that Mr. Caronia said anything false or misleading, or that anyone was harmed in any way,” said CEI Senior Fellow Gregory Conko. “They prosecuted him simply because they did not approve of the content of his speech, and that is blatantly unconstitutional.”
The U.S. Food and Drug Administration has interpreted pharmaceutical labeling laws very broadly to forbid manufacturers from speaking about uses of their products that the agency has not explicitly approved, and it has aggressively prosecuted companies for such speech. Physicians may legally prescribe drugs for these so-called “off-label” uses, and an estimated one-fifth of all prescriptions are written for such uses. Doctors can even be held liable for malpractice if they do not use a drug off-label in certain circumstances, but the FDA has long forbidden manufacturers to tell physicians about such uses.
The Second Circuit decision explains that the remedy for speech the government does not like is more speech, not First Amendment violations. The FDA “could pursue several alternatives without excessive First Amendment restrictions,” such as warnings or disclaimers that FDA has not approved the off-label use or educational campaigns to help doctors and patients distinguish between scientifically supported and unsupported or fraudulent claims. And the FDA can continue to forbid false or misleading claims. But “the government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug & Cosmetic Act] for speech promoting the lawful, off-label use of an F.D.A.-approved drug,” the court held.
“Other federal courts have previously concluded that speech about off-label uses is constitutionally protected, but the Second Circuit’s decision offers the clearest rebuke to prosecutors who have criminalized truthful speech,” Conko said. “The FDA should no longer be permitted to restrict the ability of doctors and patients to learn about important treatment options. And it cannot criminalize speech simply because it doesn’t like the speaker.”
>> For more from Gregory Conko on off-label drug promotion, see:
• Hidden Truth: The Perils and Protection of Off-Label Drug and Medical Device Promotion, Health Matrix Journal, Case Western Reserve University School of Law (August 2011)
• The FDA Should Get Real, Forbes (April 22, 2010)