The two highest-ranking leaders within the FDA’s Office of Prescription Drug Promotion (OPDP) have stepped down, according to Politico’s AgencyIQ.
OPDP director Catherine Gray and deputy director Mark Askine told staffers on Thursday that they were leaving, and their resignations took effect Friday, AgencyIQ’s Alexander Gaffney reports, citing emails shared by sources within the office.
As Gaffney suggested, the current lack of leadership at OPDP could possibly pave the way for Robert F. Kennedy Jr., secretary of the Department of Health and Human Services, to ramp up his long-stated plan of banning pharmaceutical ads by pressuring FDA Commissioner Marty Makary, M.D., to fill out the vacancies with other opponents of direct-to-consumer drug marketing.
In response to a Fierce Pharma Marketing request for comment about the changes at OPDP and how they may align with Kennedy’s goal of a drug ad ban, an HHS official said, “The FDA and HHS are committed to developing new guidelines for the industry on how they market drug risks and side effects, so the American people can make informed choices about their health through radical transparency. Critical programs within the FDA will continue as part of HHS’ transformation to better serve the American people.”
Kennedy has expressed a desire to end the practice of prescription drug advertising since well before he was confirmed as secretary of the HHS.
While running for president last year, he pledged to issue an executive order on his first day in office to ban TV drug ads. Later, after dropping out of the race and endorsing now-President Donald Trump, he promised to work with Trump to end drug commercials.
Others within the government have expressed support for a potential ban: In response to a November social media post claiming that the influx of pharmaceutical ads in the U.S. led to a decline in “creative and heartwarming” commercials, Elon Musk, a close advisor to Trump, wrote, “No advertising for pharma.”
And in a late November interview, after being selected by Trump to head up the Federal Communications Commission, Brendan Carr discussed possible routes to shutting down drug commercials, citing the successful ban on cigarette advertising on radio and TV under the Nixon administration in the 1970s.
So far, however, no such ban on drug ads has been formally proposed by the HHS or the president. And it would likely be a fierce battle to actually get a stoppage enacted, as previous court cases have repeatedly affirmed First Amendment protections of advertising speech.
The OPDP, housed within the FDA’s Center for Drug Evaluation and Research, is tasked with signing off on proposed marketing materials for FDA-approved drugs, monitoring promotional communications and reviewing complaints about potentially problematic advertising.
Earlier this month, the office was reportedly hit hard by the far-reaching layoffs at the HHS, with its research, policy and legal teams particularly affected. The new Politico report notes that among the early April layoffs were the entire staff of the office’s Division of Promotion Policy, Research and Operations, including its director and deputy director, Kathleen David and Amy Muhlberg.
Muhlberg confirmed in an April 1 LinkedIn post that she and her “entire division” had been subject to reduction-in-force orders that morning. Muhlberg has since made a weekly habit on the platform of touting the work of several of her former colleagues at OPDP—including researchers and regulatory counsels—noting that all are now looking for new roles.
Editor's note: This story was updated on April 22 with a statement from the HHS.