In advance of the Food and Drug Law Institute's (FDLI) annual advertising and promotion conference, we have conducted a year in review look-back at the enforcement letters issued by the U.S. Food and Drug Administration's (FDA’s) Office of Prescription Drug Promotion (OPDP). As of September 18, OPDP has issued only four enforcement letters and with a few months remaining in the year, it looks like it may beat its total of five enforcement letters in 2017. Following are some notable observations in FDA's 2018 OPDP enforcement letters:
- All four letters were issued as Untitled Letters
- Three out of four related to approved, marketed drugs while only one related to an investigational drug
- All three of the letters related to approved, marketed drugs involved drugs with FDA-approved labeling carrying boxed warnings
- Two of the letters relating to approved, marketed drugs involved the active ingredient "estradiol" (suggesting a particular focus by FDA on estrogen-based therapies or perhaps alternatively originating from competitor complaints)
- Two of the letters related to promotional claims viewed by OPDP representatives at medical society meetings (the American Society of Hematology December 2017 meeting and the American Society of Health-System Pharmacists June 2017 meeting) occurring in 2017
- Despite the national focus on opioids, only one letter was issued for a marketed opioid product
- For marketed drugs, FDA's objections related to false or misleading risk and benefit presentations, including: (1) the failure to include any information regarding a product's limitations for use, indication, and boxed warning statements on a booth's "principal" display panel; (2) the presentation of balancing risk information only on side panels or at the bottom of panels; (3) presentations of Phase 3 and 4 study data together with medical society guidelines implying comparative superiority to other estrogen products; (4) the failure to communicate any risk information about the product in an online video; and (5) a patient testimonial in the same online video suggesting "instant" results when data supporting the approval evaluated patients at 12 weeks
- For investigational drugs, FDA's single letter objected to claims made in a medical society booth display along with on a company website suggesting the investigational drug had "established efficacy" and without indicating that the drug "is an investigational new drug"
While more activity is likely to come in the final months of the year, the slower-than-usual pace of enforcement by OPDP appears to be a trend that will continue this year. We expect that OPDP will issue at least one warning letter this year and suspect with a citizen petition request this summer for industry guidance on biosimilar communications that OPDP could scrutinize promotional communications about biosimilars for its next batch of enforcement letters to send a message about claims FDA views as false or misleading in that space.