FDA Draft Guidance on Disclosing Risk Information Discourages Companies From Meeting Current Regulatory Requirements

By Dara Katcher Levy –

Last Friday, FDA issued the latest in a series of draft guidance documents (here and here) that address alternate ways companies can disclose risk information in consumer-directed print Rx drug promotion.  The most significant difference between the 2015 and 2004 draft guidances is in scope; the 2015 document addresses not only consumer advertising but consumer print labeling. 

FDA regulations require that advertisements and promotional labeling be accompanied by different types of information.  Advertisements are required to have a “brief summary” of risk information accompany the ad.  Labeling is generally required to be disseminated with the full FDA-approved prescribing information (PI).  In the 2015 draft guidance, FDA recognizes that the lengthy, technical PI is difficult for consumers to comprehend and provides companies with a path forward to disseminating consumer-directed print labeling with an abbreviated statement of risk (referred to as the “consumer brief summary”) as opposed to the full PI.  This abbreviated option would not only benefit consumers with “better and more actionable information” (according to FDA) but can streamline the regulatory requirements for promotional materials with having the same consumer brief summary accompany both ads and promotional labeling.  Further, the consumer brief summary could potentially translate to a significant cost savings to companies that promote products with lengthy PIs that, to date, must be reprinted and disseminated in their entirety with promotional labeling.   

The proposal is an interesting shift for FDA:  In 2008, FDA issued a Warning Letter to Boehringer-Ingelheim for violations related to the promotion of Mirapex.  Among the issues cited was the “Failure to Provide Adequate Directions for Use” in that the full prescribing information was not provided with their consumer-directed promotional labeling in violation of 21 C.F.R. § 201.100(d).  In a footnote, FDA acknowledged that, “the pieces appear to have been disseminated with the patient package insert (PPI); however, as indicated above, the regulations require that any labeling which includes claims about a drug product must contain the contents of the full FDA-approved product labeling (PI). We remind you that this includes (but is not limited to) the full text of the Mirapex FDA-approved patient labeling or PPI, which must be reprinted immediately following the last section of the required FDA approved prescription drug labeling for Mirapex or, alternatively, accompany the Mirapex prescription drug labeling (PI).”  FDA did not comment on the adequacy of the PPI to convey appropriate safety information to consumers – rather, simply cited the regulatory requirement that the full PI must accompany the materials.  It appears that the PPI for most drugs would generally meet the requirements of the consumer brief summary as set forth in the new draft guidance, although FDA recognizes that there may be certain relevant drug risks not included in the PPI that might need to be added.

We note that the 2015 draft guidance does not simply provide an alternate approach, but actively discourages companies from meeting the current regulatory requirements.  FDA states that it “strongly recommends against providing the full PI,” when disseminating consumer-directed promotional labeling, and that companies should adopt the content and format recommendations in the guidance.  The suggestion is that the guidance supplants rule-making – an overt continuation of the Office of Prescription Drug Promotion’s trend toward regulating through the issuance of guidance documents and enforcement letters. 

Beyond the regulatory issues, companies should carefully consider the potential product liability implications involved with implementing FDA’s recommended approach in terms of “failure to warn” cases.  Although we recognize that the FDA recommendations are limited to direct-to-consumer promotion (and not the learned intermediary healthcare professional facing pieces), the approach may nonetheless increase a company’s vulnerability in this area.  Before determining whether to adopt the approach, companies should also consider consistency issues in the development and dissemination of promotional materials for their portfolio of products.  Any policy decisions should evaluate the inherent product liability risks represented by the most dangerous, or most litigated, drugs in their portfolio.