FDA Draft Guidance: Relationship to Ad Hoc Coalition on FDA Internet Policy
FDA Draft "Guidance for Industry, Presenting Risk Information in Prescription Drug and Medical Device Promotion": Relationship to Ad Hoc Coalition on FDA Internet Policy.
by Arnold I. Friede and Bob Nicholas, McDermott Will & Emery LLP
Today, FDA released the attached Draft "Guidance for Industry, Presenting Risk Information in Prescription Drug and Medical Device Promotion". (Also available at http://www.fda.gov/cder/guidance/7427dft.pdf .)
The Draft Guidance does not address the unique features of sponsored links, banner ads, the subject line of e-mails to physicians or patients, or any other attribute of social media or internet communications more generally. Indeed, FDA expressly says in the Draft Guidance that the agency applies the same principles about risk disclosure in prescription drug advertising " . . . to all promotional pieces, regardless of the medium used . . . " (at page 4, lines 103-104).
The Draft Guidance is open for comment for 90 days after publication in the Federal Register, which has not yet occurred. This provides a significant opportunity for the kind of proactive submission we described in the proposal circulated to the prospective ad hoc coalition last week. In other words, without necessarily at this point initiating any new FDA proceeding (but still implicitly reserving the opportunity to do so later), an ad hoc coalition can use the comment period on the Draft Guidance to develop and then submit a response to the 14 NOVs on sponsored links while proposing an alternative paradigm for regulation of risk disclosures in sponsored links and other internet communications that meets the tenor of FDA's disclosure principles but does it in an executionally appropriate manner that acknowledges the uniqueness of the medium and its distinct technical capabilities. This is an important opportunity for a strong, collective response on behalf of the multiple stakeholders that are represented in the prospective ad hoc coalition and yet an additional reason for organizations to participate by contribution both through intellectual capital and financially.
We look forward to talking further in the conference call on June 3 at 10:00 a.m. Eastern Time. If you have questions before then, by all means, please contact us.
For more information on the Conference Call and the Ad Hoc Coalition, see the Memorandum drafted by McDermott Will & Emery.
