The Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) issued a total of six letters in 2021. Four were Untitled Letters and two were Warning Letters, sent to pharmaceutical or biologics companies for promotional materials that allegedly misbranded prescription drug or biologics products. Two of the Untitled Letters addressed prescription drug promotion, while the other two letters addressed biologic product promotion.
Some Takeaways
Three of the letters involved promotional materials that were submitted to FDA’s Bad Ad Program. The Bad Ad Program is an outreach program run by OPDP that is designed to help healthcare providers recognize when prescription drug promotion is false or misleading. The program allows healthcare providers and others to submit complaints to OPDP regarding potential false or misleading drug promotion.
One letter included violative claims regarding internet-sponsored links that discussed the company’s products. Companies should be aware that, even if a platform includes certain space or character limitations, OPDP will still expect compliance with the promotional requirements. Furthermore, two of the letters included violative claims on banner ads. The letters signify the agency’s continued monitoring and surveillance of activities conducted on the internet.
Three of the letters cited companies for failing to submit the promotional materials to OPDP under cover of Form FDA-2253 at the time of initial dissemination. Two of the letters discussed direct-to-consumer videos, signifying the agency’s monitoring and scrutiny of advertisements directed at consumers, an audience considered more vulnerable compared to healthcare providers.
Notably, one of the videos featured an interview of a company spokesperson describing her experience with the product. Although the company included a disclaimer that appeared on the screen that treatment results may vary, OPDP determined that this disclaimer did not mitigate the misleading representation created by a description of the spokesperson’s own personal experience, which was not adequately supported by the clinical trial data in the Prescribing Information for the product.
The other video featured a physician being interviewed and included claims and representations about the use and/or benefits of the product. The video, however, failed to communicate any risk information about the product. OPDP noted that viewers are referred to the product website for further information about the product; however, this does not mitigate the complete omission of risk information from the video about the drug’s safety.
The total number of letters issued in 2021 is consistent with the trend of fewer enforcement letters issued by OPDP over the course of the past 10-15 years. For instance, in 2010, OPDP issued over 50 letters. The continued decrease in letters in 2021 may signify that FDA is diverting resources to other initiatives and efforts during the ongoing COVID-19 pandemic. The decline in letters may also be a result of First Amendment challenges and the agency’s attempts to strike a balance between First Amendment rights and regulating off-label or misleading product communications.