The Latest

From the 7th floor: Social Media and the FDA - Say What?

December 10, 2009 | by Ellen Schuller

Since it held its Internet Public Meeting: Advertising and Promotion of Medical Products in 1996, the FDA has done virtually nothing to guide the industry in compliant use of the Internet. The FDA intends to deliver new internet promotion guidelines, but nothing definitive has emerged.

At this point, the same rules apply to digital media as to any other media—and the FDA has oversight of all of them. So, whatever you say on the Internet better be accurate and balanced.

The recently released Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion does a good job of clarifying how the FDA (actually DDMAC, Division of Drug Marketing, Advertising and Communications)reviews promotional materials. Central to its approach is the concept of ‘net impression’—the message communicated by all the elements of the piece as a whole. Reasonable for a printed piece, even a TV ad. But the Internet, and particularly social media, poses a problem—what constitutes ‘the piece as a whole?’

Given the lack of clarity and recent issuance of more than a few Notices of Violation, many industry marketers are wary of the Internet’s potential landmines—especially those lurking in the social media space. The possibility of a misstep increases as one enters the social realms of Twitter, Facebook and Wikis.

For years, the industry has requested Internet-specific guidance. The FDA’s position continues to be that the agency’s existing regulations can be applied to Internet promotion, but concedes that ‘additional guidance to the industry on how the regulations should be applied’ may be necessary. Enter the November 2009 public hearing on Promotion of FDA-regulated Medical Products Using the Internet and Social Media Tools.

The purpose of the hearing was to receive broad public comment regarding Internet promotion of regulated products. The hearing sought input on a range of issues, including company accountability for consumer-generated content, compliance with existing regulations in the Web context, responsibility for posting corrective information on third-party sites, use of links, and adverse event reporting. A webcast of the two-day hearing can be accessed until December 18, 2009 at http://www.capitolconnection.net/capcon/fda/111209/FDAarchive.htm.  Transcripts of the meeting will be available at http://www.regulations.gov.
Additionally, it’s not too late to be heard. Written or electronic comments will be accepted until February 28, 2010. Submit electronic comments, identified with docket number FDA-2009-N-0441, to http://www.regulations.gov.

^{* image courtesy of biojobblog.com}