Since the new administration assumed office and filled political appointments at FDA, one new emphasis seems to be assuring the prominent display of risk information in drug and device advertising. Since late 2009, dozens of warning and untitled letters have been issued by the FDA Division of Drug Marketing, Advertising and Communications (DDMAC). It appears that the catalyst for most of those letters remains off-label promotion. However, DDMAC then frequently reviews and criticizes the prominence of risk information that previously may have been found adequate. This is a newly energized priority of DDMAC in all advertising reviews.
In May 2009, FDA announced its expanded scrutiny into this area by issuing a draft guidance for industry entitled "Presenting Rick Information in Prescription Drug and Medical Promotion." The primary theme of this guidance is that more complete risk information is required whenever efficacy claims are made, and the format of that information must be much more prominent to parallel that of the positive message. Formerly, it was sufficient to include a "fair balance statement" upfront, and reference to the package insert included with the brochure. Today, under DDMAC's new enforcement interpretations, expanded risk information is required to be spelled out prominently on the first page (using bolded headings and backdrops equivalent to the most prominent display of efficacy information). Moreover, inclusion of the entire package insert later in the promotional information does not mitigate what DDMAC has determined to be a lack of fair balance throughout the earlier material presented.