FDA Needs New Policy on Off-Label Promotions, Industry Groups Say


Pharmaceutical and medical device industry groups urged the FDA Nov. 9 to revamp its policies on communications about unapproved, or off-label, uses of products.

The comments were made at a Food and Drug Administration meeting held to obtain input on the policies. FDA Commissioner Robert Califf said at the meeting that “off-label use is associated with more adverse events” and the agency is seeking input to ensure that its policies protect the public health.

Biopharmaceutical companies have been pushing in recent years to loosen what they see as overly burdensome and unclear FDA regulations on the types of product information they can discuss with doctors and other health professionals. Meanwhile, recent court cases challenging the constitutionality of the agency’s off-label promotion regulations have raised doubts about whether the federal government can continue to restrict manufacturers from sharing truthful information about the off-label uses of drugs and medical devices.

The FDA should issue new guidance or regulations to update its current policies, said representatives from the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Innovation Organization (BIO) and the Advanced Medical Technology Association (AdvaMed). Among other things, they said payers need off-label information in order to make decisions about coverage and ensure patients have access to the treatments they need.

John Kamp, executive director of the Coalition for Healthcare Communication in New York, told me Nov. 7 in advance of the meeting he expects the FDA will release a draft guidance on off-label communications “fairly soon.”

“I think they’ll probably focus on” Section 114 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) in the draft guidance, Kamp told Bloomberg BNA. Section 114 required the FDA to give more guidance on discussion with payers.

If the FDA issues draft guidance on Section 114, “it will open up the discussion with payers,” Kamp said. “The FDA either has to act or they have to let the courts take the initiative. I think it’s time for FDA to act.”

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