In its fourth enforcement letter of 2018, the Office of Prescription Drug Promotion (OPDP) takes aim at a marketed drug’s sell sheet solely on the basis of misleading efficacy claims, the first letter to do so in over 3 years.
The letter, issued August 16 to Ascend Therapeutics, asserts that promotional statements claiming EstroGel (estradiol gel) provides the lowest effective dose of estradiol therapy are misleading as there are other estrogen therapies approved for the same indications with lower doses. While the letter is fairly unremarkable in content, the concept of an enforcement letter based solely on efficacy claims is something that we have not seen in several years.
In June 2015, OPDP issued a letter to Ascend about misleading promotion for EstroGel through omission of important risk information. Since this letter, OPDP continued the trend in each of its letters about marketed products, citing risk communication issues, even where OPDP also took aim at efficacy presentations.
In looking back at this trend, we saw that after a letter in August 2015, OPDP enforcement took a hiatus for the remainder of that year. This coincided with Pacira Pharmaceutical’s September 8, 2015 filing of a Complaint against FDA [hyperlink to 12/15/15 blog post] seeking to prevent FDA from bringing an enforcement action against the company for truthful and nonmisleading speech. In December 2015, FDA rescinded a September 22, 2014 OPDP Warning Letter issued to Pacira. We suspected that OPDP’s 2016 enforcement letters were carefully crafted to avoid issues raised in the Pacira case as well as other First Amendment cases (and FDA losses) brought by industry (see our previous post here).
Do we think that OPDP’s recent letter marks a shift in this approach? Not really. Given the particular statements at issue, we think that OPDP felt confident about the misleading nature of the “lowest dose” claims given the approval of lower dose products. We also note that the promotion meets several stated OPDP priorities for enforcement (e.g., Boxed Warning product, product cited for past violations). The takeaway for industry is that pushing the envelope on efficacy still needs to fall within a gray area – overtly misleading claims may still trigger enforcement, particularly if promotion falls within a stated OPDP priority.