Off-Label Communications

While the FDA has had a long-standing policy of permitting drug, biologics, and medical device companies to respond to unsolicited requests for information about off-label use of their products, there has been significant discussion over what constitutes “unsolicited” in this context. On July 5, 2011, seven medical products companies filed a “citizen petition” with the FDA, asking for clarification of several issues, including: 1) responses to unsolicited requests; 2) the meaning of scientific exchange; 3) the appropriate interactions with formulary committees, payors, and similar entities; and 4) the dissemination of third-party clinical practice guidelines. Although the Citizen Petition is pending, on Dec. 23, 2011, the FDA issued a draft guidance that addresses the first issue in the Petition. In the draft guidance titled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices,” the FDA describes how drug, biologics, and medical device manufacturers should respond to unsolicited requests for off-label information, including ' for the first time ' communications via the Internet and social media. (“Draft Guidance” is the FDA's proposed approach to compliance with a legal or regulatory requirement. When finalized, the draft guidance will represent the FDA's current thinking on this topic. Neither a draft nor final guidance creates or confers any rights for or on any person and does not operate to bind the FDA or the public. A person can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.)