BIO Comments to FDA on Unsolicited Requests for Off-Label Information

Dear Sir/Madam:

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Agency’s Draft Guidance for Industry on Responding to Unsolicited requests for Off-Label Information About Prescription Drugs and Medical Devices (Draft Guidance). This Draft Guidance, as well as FDA’s December 28, 2011 Notice; Request for Comments on Communications and Activities Related to Off-Label Uses[1]are important steps in developing policies on manufacturer communications involving off-label information. BIO is submitting separate comments to FDA addressing the Agency’s December 28, 2011 Notice and Request for Comments.  Further, BIO looks forward to additional opportunities to comment on other issues raised in the July 5, 2011 citizen petition submitted to FDA, including interactions with formulary committees, payors and similar entities, and dissemination of third-party clinical practice guidelines. [2]