Off-label Promotion

Kamp to Urge FDA to Provide Clear Guidance on Off-label Communication at November Hearing

Oct. 31, 2016 – In testimony at the upcoming off-label hearing at the FDA, Coalition for Healthcare Communication Executive Director John Kamp will emphasize that FDA must quickly develop rules that are clear and consistent with the First and Fifth Amendments.

The FDA today released the draft agenda for its two-day meeting on manufacturer communication of unapproved uses of approved or cleared medical products. The meeting, to be held Nov. 9-10 in Silver Spring, Md., will be kicked off by remarks from Associate Commissioner for Policy Leslie Kux and Commissioner Robert Califf.

Following these opening remarks on Nov. 9 will be 35 speakers from industry, medical and patient associations, insurance companies, and industry associations, including AdvaMed, BIO and PhRMA, as well as the Coalition for Healthcare Communication. Kamp intends to tell FDA that although the U.S. Constitution requires a policy change, a more compelling reason is to get more and better information about medicines to doctors, patients and other caregivers.

“Much of FDA’s communication regulation to date has been focused on print media, but communications has evolved to embrace social change, new media and evolving science,” according to Kamp. “Because medicine sponsors have the most information about their products, FDA policies need to change to better advance patient care,” he said.

Kamp added that the much-needed updated guidance must “be clear and understandable to all under the Due Process clause of the Fifth Amendment” and “respect the Central Hudson First Amendment test for commercial speech.”

“Vague rules create excessive agency discretion, lead sponsors to take hyper-conservative positions and leave both drug sponsors and their agency partners without clear regulatory guidance,” Kamp noted.

On Nov. 10, the FDA will hear from at least 28 speakers from consumer groups, academia and other entities.