Off-label Promotion

FDA Extending Unapproved Use Communications Comment Period

Dec. 15, 2016 – The FDA announced that it would extend the comment period on manufacturer communication regarding unapproved uses of medical products by another 90 days, further delaying any agency action on the matter after a prolonged wait by industry for guidance.

“We are taking this action to allow interested persons additional time to submit comments,” the announcement states. “FDA is engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical products, and the comments received in response to this notice of public hearing will inform FDA’s policy development in this area.”

However, many in industry believe that the agency has had ample time and received sufficient comments in order to act. At the two-day public hearing on the matter held Nov. 8-9, industry speakers argued that off-label use is legal, that industry’s speech about off-label use is protected by the First Amendment as long as that speech is truthful and non-misleading, and that the FDA should provide detailed guidance now on how to discuss unapproved uses without being subject to an FDA enforcement action.

“It’s time for the FDA to act,” Coalition for Healthcare Communication Executive Director John Kamp said after the hearing. “This has been the subject of discussion for 20 years.” Now, Kamp noted, industry may be left hanging well into 2017.

FDA intends to formally announce this extension to April 10, 2017, in the Federal Register “in the near future.”