March 15, 2021 – The FDA Office of Prescription Drug Promotion (OPDP) marked the 10-year anniversary of the Bad Ad Program in 2020, and kicks off 2021 with three enforcement actions – two Warning Letters and one Untitled Letter – two of which cited the Bad Ad Program as the source of complaints about potentially problematic prescription drug promotion.
The Bad Ad Program is an outreach program designed to help healthcare providers (HCPs) recognize potentially false or misleading prescription drug promotion, and to raise awareness among HCPs, including physicians, physician assistants, nurse practitioners, nurses, pharmacists, pharmacy technicians, and trainees, about what that promotion might look like and how they can easily report it.
At a March 8 session of the Drug Information Association (DIA) Advertising and Promotion Regulatory Affairs Conference, OPDP Acting Director Catherine Gray, PharmD, stated that the Bad Ad Program has been very successful. She explained that in 2010, OPDP received 120 complaints about prescription drug ads or promotional materials, but these complaints now average 208 per year, a 73-percent increase.
In July 2020, former OPDP Director Tom Abrams wrote that when Bad Ad complaints met OPDP criteria for further FDA action over the years, “OPDP moved forward with a risk-based compliance strategy to put a stop to the promotion. Even in cases where the report may not have led to a compliance action, it still served as valuable information to focus our ongoing surveillance activities.”
Two recent enforcement actions – a Feb. 12 Warning Letter to CooperSurgical Inc. and a March 8 Untitled Letter to Biohaven Pharmaceuticals – cited Bad Ad Program complaints in response to direct-to-consumer (DTC) videos.
In the Warning Letter to CooperSurgical, OPDP states that a DTC video for Paragard® (intrauterine copper contraceptive) was submitted to the Bad Ad Program. According to OPDP, the video “is false or misleading in that it presents efficacy claims for Paragard, but fails to communicate any risk information associated with its use.”
This is particularly concerning to the FDA because Paragard has a long list of contraindications, significant warnings and precautions. At the DIA meeting, Gray stated that the DTC video in question was primarily a physician interview that omitted almost all risk information. The Warning Letter states that although viewers are referred to a Paragard website for further information, “this does not mitigate the complete omission of risk information from the video.”
Further, the video had not been submitted to OPDP at the time of initial dissemination. “There is no excuse for failing to submit promotional materials,” according to Gray. CooperSurgical had previously received an Untitled Letter in 2017 about the omission of important risk information in a Paragard DTV television ad.
The Untitled Letter to Biohaven states that a DTC video for Nurtec™ ODT (rimegepant) orally disintegrating tablets, which is indicated for the acute treatment of adult migraines, features an interview with paid spokesperson Khloé Kardashian that makes false or misleading claims and representations “about the risks associated with and the efficacy of Nurtec ODT.
Specifically, Kardashian makes claims in the interview about her experience with the product that misleadingly suggest that patients treated with Nurtec ODT will experience “relief” within 15-30 minutes of taking the drug which are not supported by clinical trial data. OPDP also objected to Kardashian using the term “gamechanger” in reference to the drug and making comparative claims about the product that “have not been demonstrated.”
Benefit claims about Nurtec ODT are included in the video and audio portion of the video, but risk information is presented “in text-only format and in small font.” The placement and weight given to risk information in the video undermine “the communication of risk information,” OPDP states in the enforcement letter.
Additionally, the interview section of the video does not convey that Nurtec ODT is approved for the acute treatment of migraine, not for the preventive treatment of migraine. Biohaven also failed to submit the video to OPDP at the time of initial dissemination.
The Coalition for Healthcare Communication also notes that the FDA’s recent changes regarding how the public accesses and views OPDP Warning Letters and Untitled Letters decentralize the information and now involve dual-mechanism searches. Although both types of enforcement letters previously were located on the OPDP section of the Center for Drug Evaluation and Research (CDER) Compliance website, last week the agency announced that it is posting Warning Letters and Untitled Letters to separate FDA webpages.
Gray told the DIA conference attendees that this move was done to put OPDP in compliance with the practice of other FDA offices of only posting Warning Letters in one location – the FDA Warning Letter webpage (this is where OPDP Warning Letters dating back to 2017 will now be located – users can search selecting “Office of Prescription Drug Promotion” as the Issuing Office filter). Untitled Letters (2017-present) will remain on the CDER Compliance Letter webpage. and are shown by year, as in the past. OPDP Warning Letters and Untitled Letters from 1998-2016 will only be listed on the archived FDA webpage.