ADDITIONAL COMMENTS ON FDA DRAFT GUIDANCE ON RISK DISCLOSURES
by Arnold I. Friede
It is true that FDA in the Draft Guidance officially adopts the "reasonable man" standard for interpreting advertising and promotional claims. That is nice and long overdue. And the agency also says that in interpreting advertising it attends to the First Amendment. Likewise nice and long overdue. At the same time, of course, FDA continues to aggrandize entirely to itself the right and the ability to decide what the "reasonable man", whether physician or consumer, understands in the context of any given promotional piece.
By contrast, the FTC's Deception Policy Statement, from which FDA explicitly borrows the "reasonable man" standard, acknowledges that except when the claim is explicit on its face, the Commission will usually consider consumer survey evidence in determining what meaning to ascribe to the advertising. FDA's apparent unwillingness to consider anything but its own views in determining what the "reasonable man" thinks suggests that adoption of that standard may amount to nothing more than elevation of form over substance. And it belies the agency's professed attention to the First Amendment. Moreover, in describing the adequacy of risk disclosures, and while acknowledging in a footnote the concept of over warning, FDA in the Draft Guidance makes it clear that encyclopedic disclosures remain the legal norm.
At the same time, FDA does not mention its own very recent data which shows that even those consumers who focus on the risk information spend so little time on them one has to question the ongoing viability of a disclosure regime based on the encyclopedia. And of course as I mentioned yesterday, FDA is applying the same rules to all promotional communications regardless of the medium. This is a serious problem in the context, particularly, of new media, which has different technological capabilities and limitations.
For more information on this subject:
See yesterday's post by Arnie Friede on FDA Guidance.
For more information on the Conference Call and the Ad Hoc Coalition, see the Memorandum drafted by McDermott Will & Emery.
