FDA issues guidelines for responding to off-label info requests

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The FDA shared in a December 2011 draft guidance its current thinking on how manufacturers and distributors of prescription drugs and medical devices should respond to unsolicited requests for information about unapproved, off-label uses related to their FDA-approved products.

Due to the ease with which individuals and organizations can seek information using the internet, drug manufacturers may encounter requests for off-label information about their products through websites, discussion boards, chat rooms or other public electronic forums that they maintain and over which they have full control, as well as through venues over which they do not control.

In the draft, the FDA encouraged drug manufacturers to respond to public unsolicited requests for off-label information made in these forums to ensure that accurate information is being provided, especially because other internet users are able to respond with inaccurate information. Additionally, the FDA encouraged drug manufacturers to respond to private unsolicited requests, such as those made via telephone and personal email.

According to the draft, drug manufacturers choosing to respond to public unsolicited requests should:

  • Only respond to requests that specifically pertain to its products and not its competitors’;
  • In public forums, provide a contact method in response to requests for off-label information rather than making that information public and clearly state that the requests pertains to an unintended use of the product;
  • Disclose individual information regarding the responders’ employment or involvement with the company;
  • Do not publish public responses that are promotional in nature or tone; and
  • Include a mechanism for providing readily accessible current FDA-required labeling.

Drug manufacturers responding to private requests should:

  • Provide information only to the individual requesting it in one-on-one communication;
  • Answer only the specific questions asked;
  • Be truthful, non-misleading, accurate and balanced;
  • Provide information that is scientific in nature;
  • Provide responses from within medical or scientific departments and not marketing or sales departments; and
  • Include a copy of the FDA-required labeling, a statement notifying the recipient that their request pertained to an unapproved use, a statement detailing the FDA-approved use, safety information and a complete list of references for all of the information disseminated in the response.

The draft guidance does not establish legally enforceable rights or responsibilities and the FDA stated it welcomes comments and suggestions within 90 days of its publication. The draft guidance is available in its entirety here.