Spring 2022 was the last time the FDA’s ad watchdog, the Office of Prescription Drug Promotion (OPDP), took issue with a pharma’s drug promotion, but, after a long hiatus, the red pen is back out.
In the crosshairs for the first time this year is Xeris Pharmaceuticals and promotional materials for its Cushing disease therapy Recorlev.
The OPDP, in an untitled letter sent to the company this month, found that several branded drug webpages “make false or misleading claims and representations about the safety and efficacy of Recorlev.”
The watchdog adds that these “violations are especially concerning from a public health perspective because the promotional communications create a misleading impression regarding the safety and effectiveness of Recorlev.”
That’s because this drug, which blocks the making of cortisol and testosterone to help Cushing disease patients manage their disease, comes with “serious and potentially life-threatening risks,” including boxed warnings.
While Xeris says that "[s]ide effects can occur with Recorlev, including some that are serious," it failed to talk about the drug’s boxed warnings or specific side effects associated with the drug, including those that are potentially fatal, a big no-no for the OPDP.
On the efficacy side, the OPDP found that on one of the webpages for the drug, Xeris claimed “67% of patients who moved on to the second part of the study had normal cortisol levels by the end of the study,” but the watchdog says that this “misleadingly overstates the efficacy of Recorlev” and points out clinical data from the company show these levels are around half that 67% figure.
All of this means that the webpages are in violation of the watchdog’s rules, and Xeris must, within the next two weeks, tell the OPDP how it’s planning to rectify these issues.
This is the first untitled letter to come from the OPDP this year. Only three were issued in 2022, the last being for Bausch last March.