Recently, the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued two Notice of Violation (“NOV”) letters in one day.1 Foreigner’s 1978 “Double Vision” album and title track come to mind.2 Both NOVs focus on direct-to-consumer (“DTC”) promotion. We highlight the main issues and offer our own observations in this Bulletin.
Highlights
- Both NOVs included DTC promotion — one a brochure, made for a vaginal gel prescription product; and the other one a television advertisement, produced for a product indicated for adjunctive treatment of major depressive disorder in adults.
- In the first case, the brochure claimed that 99% of pregnancies were prevented “per act of sex.” However, the agency noted that “per act of sex” is not a validated measure to show efficacy in contraceptive products.
- FDA emphasized that contraception depends on the timing of intercourse in relation to ovulation, and calculating the overall likelihood of pregnancy per act of intercourse does not take into account that the likelihood of pregnancy is not the same throughout the menstrual cycle.
- The Prescribing Information (“PI”) said efficacy was evaluated through cumulative failure rates over specific lengths of exposure.
- While the brochure contained the statement, “these data are not found in the Product Information and have not undergone the same rigorous evaluation as other data from the study,” FDA said the statement did not mitigate the misleading nature of the 99% efficacy claim.
- In the second NOV, FDA objected to claims in the DTC television advertisement about the efficacy of the product.
- The advertisement promoted that the product could reduce depression symptoms in patients by 62% when taken with an antidepressant.
- FDA stated that the data from the first study cited in the PI indicated only an 11.9% reduction in depression symptoms for the 2 mg dose promoted in the advertisement. The agency also considered a second study referenced in the PI, which only supported a 4.8% reduction in symptoms for a 1 mg tablet and a 7.4% reduction in symptoms for a 3 mg tablet.
- FDA also raised other concerns with how the 62% reduction claim was determined.
- The label contained the statement, “individual results may vary,” but, similar to the first NOV, FDA found that the statement did not mitigate the misleading claim.
AGG Observations
- OPDP has issued only two other NOVs this year (one targeted a social media post; the other focused on a consumer website), so we are up to four total NOVs in 2023. In 2022, OPDP issued three NOVs.3 OPDP has sent one Warning Letter this year, the same number as in 2022.4
- It is difficult to determine whether there is a trend of increased enforcement here as the numbers remain low, particularly in comparison to years past.
- Companies cannot overlook what data is in the PI and must present such data truthfully and completely — FDA does not overlook this data.
- Disclaimers may minimize risk; they do not eliminate the risk. In both cases, companies tried to qualify the promotional messaging, but FDA found that those did not “mitigate” the misleading presentation of information.
- Don’t let double vision get the best of your company.
[1] The NOVs can be accessed here: https://www.fda.gov/drugs/warning-letters-and-notice-violation-letters-pharmaceutical-companies/untitled-letters.
[2] Another song title option was Eddie Money’s, “Two Tickets to Paradise,” but we don’t equate an FDA NOV with “paradise.”
[3] AGG prepared Bulletins on these NOVs, which can be accessed here: https://www.agg.com/news-insights/publications/its-a-heartache-fdas-opdp-issues-an-untitled-letter-for-unlawful-promotion-of-a-cholesterol-lowering-drug-product/; https://www.agg.com/news-insights/publications/out-of-touch-fda-takes-exception-with-drug-companys-promotion-for-topical-drug-product/; https://www.agg.com/news-insights/publications/freeze-frame-fda-issues-an-untitled-letter-for-an-unlawful-instagram-post/; https://www.agg.com/news-insights/publications/fdas-not-dead-yet-the-agencys-opdp-issues-first-untitled-letter-for-2023/; https://www.agg.com/news-insights/publications/what-would-al-stewart-think-about-opdps-latest-untitled-letter/.
[4] https://www.agg.com/news-insights/publications/fda-imposes-its-weight-and-puts-the-load-on-a-drug-company-for-unlawful-promotion/.
