by Wendy C. Goldstein and Kathleen A. Peterson

On December 27, 2011, the U.S. Food & Drug Administration ("FDA"), Office of Prescription Drug Promotion ("OPDP") (formerly the Division of Drug Marketing, Advertising, and Communications) released a new draft guidance document titled "Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices" (the "Draft Guidance"). The OPDP will accept comments on the Draft Guidance through March 29, 2011.

The FDA has a longstanding policy of permitting pharmaceutical manufacturers to respond to unsolicited requests for medical information about their products, even where such information pertains to unapproved products or uses. However, there has been considerable debate over what constitutes "unsolicited" in this regard. In July 2011, a group of seven manufacturers filed a "citizen petition" with the FDA, requesting FDA clarification of the following issues: (1) Manufacturer Responses to Unsolicited Requests; (2) "Scientific Exchange"; (3) Interactions with Formulary Committees, Payors, and Similar Entities; and (4) Dissemination of Third-Party Clinical Practice Guidelines.

The Draft Guidance relates only to the first of these requests. The Draft Guidance further states that it is not intended to address unsolicited requests for information about products that are not approved for any use.

Read the full alert here