FDA ad watchdog sends first reprimand of 2023 to Xeris over ‘misleading’ drug claims

It’s been one year since the FDA delivered a reprimand over pharma promotions, ending the drought last week with an untitled letter to Xeris Pharmaceuticals. Its consumer website for Cushing’s syndrome drug Recorlev contains “false or misleading claims” along with safety and efficacy problems, according to the untitled letter from the Office of Prescription Drug Promotion (OPDP).

The “What is Recorlev?” web page contains several misleading efficacy claims not supported by Xeris’ clinical studies, OPDP said. Meanwhile, the “Taking Recorlev” web page misleads on possible risks by minimizing “the serious and significant risks” associated with the drug, failing to disclose information about the drug’s boxed warnings and side effects which include potentially fatal ones, the letter said. Politico first reported about the letter on Monday.

The last time the OPDP issued an untitled letter was in June 2022 — and it was one of only four total letters last year, three untitled and one warning.

Mark Senak

Mark Senak, SVP and partner at FleishmanHillard, who tracks FDA actions on his Eye on FDA blog, commented on the big drop in enforcement letters since 2013, when 23 letters were issued, and even starker going back further to 1998, when OPDP sent 156.

He doesn’t attribute the decline to the pandemic — the slowdown was well underway before 2020 — but added via email, “I do, however, think that there has been a shift in priorities and there have been some statements in the past in this regard by key officials.”

He pointed to a Pink Sheet report several years ago that reported then-CDER chief Janet Woodcock content to let advertising competitors “duke it out” and focus only on cases where human safety was at stake.

Senak said:

While one can disagree with a characterization in a promotional communication and whether or not it is completely accurate, it is not likely to result in someone’s death or grave harm. And so in the end, I think FDA/OPDP has undergone a policy change that has been long underway and gradually arrived at that the agency only seems to act (1) where there is a violation that is more than just a technical mischaracterization or (2) provides the agency with an opportunity to clarify policy with regard to a particular type of communication or a specific practice, such as the 2009 issuance of 14 letters in a single day regarding the “one-click” rule utilized up until then in banner ads.

OPDP directed Xeris to respond within 15 days of the June 7th send date to address its concerns and explain either disagreement with the assessment or plans to fix the issues. Xeris did respond to requests for comment.

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