FDA Issues Two Important Documents Concerning Communication of Off-Label Information


Draft Guidance Could Limit Manufacturers’ Ability to Respond to Unsolicited Requests During Live Presentations and on the Internet

This week, the Food and Drug Administration (“FDA”) issued two important documents relating to drug and device manufacturers’ communications about unapproved or uncleared (i.e., off-label) uses of their products. FDA’s Draft Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices (“Draft Guidance”), issued on December 27, 2011, proposes new recommendations for manufacturers to follow when responding to unsolicited requests for off-label information. A Federal Register notice published on December 28, 2011, entitled Communications and Activities Related to Off-Label Uses of Marketed Products and Use of Products Not Yet Legally Marketed, responds to a Citizen Petition filed by Ropes & Gray and another law firm on behalf of seven drug and device manufacturers and provides industry with an opportunity to comment on policies regarding scientific exchange.

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