OPDP's One-Two Combo On Quantitative Efficacy Claims In DTC Ads

It has been a few weeks, but we thought it important to do a deeper dive on the two Office of Prescription Drug Promotion (OPDP) Untitled Letters published in November. The letters, both issued on October 31, 2023 but published in early November, were to Otsuka and Evofem for misleading efficacy claims relating to overstating the efficacy of their respective products in direct-to-consumer (DTC) advertisements. Both letters addressed quantitative efficacy presentations—attacking the numbers as well as the underlying methodology for obtaining those numbers. The letters come on the heels of FDA finalizing its Guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.