Off-Label Drug Promotion Could Happen if Stakeholders Agree


Biopharmas could soon be freer to publicly discuss and promote drugs for uses not approved by the FDA if the stakeholders can get together, sources say.

Physicians may prescribe drugs for off-label uses because the Food and Drug Administration doesn’t regulate the practice of medicine. But the agency does regulate drug promotion and has held that drugs can only be promoted for FDA-approved uses. It has taken this position to ensure the safety and efficacy of drugs under the Food, Drug and Cosmetics Act.

“Biopharmas have paid millions of dollars in settlements over this,” Steve Lieberman, a partner with Rothwell, Figg, Ernst, & Manbeck, P.C., in Washington, told me in an April 5 phone interview after he had spoken at a session on the issue at the BIO IP Counsels Committee Conference in Newport Beach, Calif. Consumer and patient groups have opposed any departure from the FDA policy. But Lieberman told me factors are suggesting the policy could change.

The most recent factor is the confirmation May 9 of Scott Gottlieb as the new FDA administrator. During his Senate confirmation hearing April 27, he appeared to support the idea of loosening off-label communications restrictions. He said he believes “that patients and physicians make the best decisions when they have access to as much truthful, nonmisleading, scientifically based information as possible.”

On the state level, on March 21, Arizona became the first state to enact a law—The Free Speech in Medicine Act (H.B. 2382)—to allow drug companies to communicate off-label uses of their products.

And, as Lieberman pointed out, there are two recent court decisions that indicate biopharmas have a First Amendment right to truthfully promote off-label use. The most important is the U.S. Court of Appeals for the Second Circuit’s ruling in U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012), which reversed a conviction for the introduction of misbranded drugs, stating, “[T]he government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug, and Cosmetics Act] for speech promoting the lawful, off-label use of an FDA-approved drug.”

“FDA has been fighting this even though it lost in court twice,” Lieberman told me. “But the rulings stress the speech can't be restricted as long as it is not misleading.”

Finally, there is the FDA itself, which held a meeting on the issue Nov. 10 and requested comments in response to an agency memorandum by April 19. Biopharma industry groups submitted comments in support of loosening the off-label restrictions, and patient and consumer groups voiced opposition to any change.

For my part, I remember the tragedy that played behind the court’s 2012 decision in Caronia. In 2006, Dr. Peter Gleeson was arrested at a train station in Long Island, New York, near where my wife was born, and was later indicted because he had, at the request of a drug company, spoken to industry groups about the off-label use of one of the company’s drugs and was paid for his speeches. The FDA had hired another physician to tape his remarks. He pleaded guilty to a misdemeanor and was barred from receiving payments from Medicare and Medicaid. When the drug company reached a $20 million settlement with the government, he lost his license to practice in two states. Gleeson committed suicide in February 2011, almost two years before the appeals court vacated the conspiracy judgment against the drug company on First Amendment grounds.

A lot is at stake. It can only be hoped that industry, consumer and patient groups can come together and that the FDA and the courts can guide them.

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