After a slow start to the year, the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) now has a total of five enforcement letters for 2023 (four Untitled Letters and one Warning Letter) with potentially the last two letters of 2023 issued on Halloween. Our summary of the first three letters can be found here and here. The first of the latest two Untitled Letters was issued to a biopharmaceutical company for what OPDP considered to be misleading claims about the efficacy of its on-demand contraceptive product (vaginal gel) in a direct-to-consumer (“DTC”) patient brochure. Similarly, the second Untitled Letter was issued to a pharmaceutical company for making false and misleading claims in its DTC television and banner ads about the efficacy of its prescription medication used to treat major depressive disorder in adults.
In the first Untitled Letter, OPDP found that the biopharmaceutical company made claims that created a misleading impression by overstating the efficacy of its “on-demand” contraceptive product in a 2022 patient brochure. OPDP stated that “the 99% pregnancy prevention rate claimed in the brochure is based on efficacy ‘per act of sex’ which is not a validated measure to demonstrate the efficacy of contraceptive products.” More specifically, OPDP found that using the “per act of sex” measurement to calculate the contraceptive’s pregnancy prevention rate “misleadingly overestimates the effect” of the contraceptive on pregnancy prevention because it “incorrectly assumes that the likelihood of becoming pregnant is the same with each act of sex throughout the menstrual cycle.” The Prescribing Information (“PI”) stated that efficacy was evaluated based on an analysis of “cumulative failure rates over specific lengths of exposure.” While the company included a disclaimer that acknowledged that the information was not found in the PI for the product, the FDA found that this was not sufficient to mitigate the “misleading overstatement of efficacy created by these claims.”
In the second Untitled Letter, OPDP took issue with the company’s claim in a television ad that stated the product “was proven to reduce depression symptoms 62% more than the antidepressants alone.” OPDP also raised concerns over similar claims made in a banner ad. OPDP found that the claims made in both the television ad and the banner ad “overstate[d] the efficacy of the drug by misrepresenting the efficacy profile…” More specifically, OPDP stated that the claims “misleadingly suggest that a patient can expect to experience a 62% reduction (i.e., an improvement) in depression symptoms when added to an antidepressant (“ADT”) alone.” In reality, the drug’s trial data cited in the PI demonstrated an 11.9% reduction in Study 1 and a 7.4% reduction in Study 2—two significantly lower rates than the promoted rate of 62%. Moreover, OPDP explained that although the television ad and banner ad included the SUPER “Individual results may vary,” it did not mitigate the misleading nature of the promotional material regarding the “magnitude of benefit that patients can expect when taking [the drug product] and an ADT.”
Practical Takeaways
- OPDP continues to pay close attention to claims related to the efficacy of a drug that is based on data not found in the product’s PI. Companies should continue to be careful when presenting this type of data to avoid overstating the product’s efficacy or creating a misleading impression when presenting study data.
- As highlighted in both letters, companies should keep in mind that using a disclaimer such as “Individual results may vary,” or other disclaimers acknowledging that the information is not found in the PI may not mitigate the misleading impression created by the promotional communication.
- With less than 20 days left in 2023, OPDP’s enforcement will likely be capped at five letters this year. While it is difficult to discern trends given the low number of enforcement actions, it is still a good reminder that OPDP is “watching,” and the potential for receiving an Untitled or Warning Letter should still be top of mind for companies when reviewing promotional materials.
For more information on the advertising and promotion of drugs, biologics or medical devices, please contact:
- Carolina Wirth at (202) 780-2989 or cwirth@hallrender.com;
- Jemalyn Harvey at (202) 780-2990 or jharvey@hallrender.com; or
- Your primary Hall Render contact.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
