The U.S. Food and Drug Administration (FDA) published two Federal Register notices today announcing its intent to study different aspects of drug promotion. In Docket No. FDA-2017-N-1315, the FDA solicited comments regarding its planned research titled, “Experimental Study on Risk Information Amount and Location in Direct-to-Consumer Print Ads.” The FDA explained that direct-to-consumer (DTC) ads contain risk information in the important safety information (ISI) and the brief summary, creating a potential to overwarn consumers. The FDA stated that “detailing too many risks may lead consumers to discount all risks, or miss the most important risk information.” The FDA also raised a second concern related to habituation, which is when readers see the same warning repeatedly and cease to pay attention to it. The FDA outlined its plans to investigate how such repetition and overwarning apply to the presentation of risks in promotional prescription drug ads.

The FDA also solicited comments by August 18, 2017 regarding its planned research titled, “Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion”, Docket No. FDA-2017-N-1779. The FDA is proposing to study the impact of disclosures, specific statements that modify or qualify a claim, to determine whether they influence prescriber comprehension and subsequent decisionmaking. Specifically, the FDA will study whether different aspects of disclosures influence their effectiveness, including the level of technicality used in the disclosure, the addition of a general summary statement of frame the disclosure, and the clinical training of the health care professional reviewing the disclosure.

Pharmaceutical companies and other interested third parties should carefully review these disclosures and consider submitting comments to the FDA by August 18, 2017.


Posted by Cooley