Monday, January 2, 2012

FDA Quietly Issues Draft Guidelines for Manufacturers Responding to Off-label Info Requests via Social Media

A couple days after Christmas, with no warning or fanfare, the Food and Drug Administration (FDA) posted its long-awaited social media guidelines for pharmaceutical and medical device companies. Sort of. In the draft guidance for industry entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” (see the Federal Register notice), the FDA for the first time considers communications via "emerging electronic media."

We see nothing here that should alter HyperbaricLink's position on FDA Clearance and UHMS Approval and the marketing of hyperbaric chambers as Class II medical devices. We note, with emphasis, the language beginning at line 392 of the document:

A firm’s public response to public unsolicited requests for off-label information about its named product should be limited to providing the firm’s contact information and should not include any off-label information.
  • The firm’s public response should convey that the question pertains to an unapproved or uncleared use of the product and state that individuals can contact the medical/scientific representative or medical affairs department with the specific unsolicited request to obtain more information.
  • The firm’s public response should provide specific contact information for the medical or scientific personnel or department (e.g., e-mail address, telephone number, facsimile) so that individuals can follow up independently with the firm to obtain specific information about the off-label use of the product through a non-public, one-on-one communication.

Click here to download the 15-page guidance document [PDF]. Interested readers will find worthwhile commentary and analysis at Ad Age ("FDA's Social-Media 'Guidelines' Befuddle Big Pharma: After Two-Year Wait, Guidance Addresses Only Off-Label Uses of Drugs") and on the Pharma Marketing Blog.

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