In the wake of sweeping cuts at the FDA’s Office of Prescription Drug Promotion (OPDP), Sen. Dick Durbin, D-Ill., is questioning how effectively the agency can continue to regulate pharmaceutical advertisements.
The lawmaker sent a letter to FDA Commissioner Marty Makary, M.D., this week requesting information about the regulator’s “operational capacity” to carry out that work, citing both the staff cuts and Makary’s own “recent public statements expressing an interest in “mak[ing] sure that the information being presented … in those ads … is a complete picture.”
The layoffs in particular “raise major questions about whether FDA has the personnel, expertise, and capacity to fulfill its mission to regulate prescription drug advertisements,” Durbin wrote.
Late last month, the two highest-ranking OPDP leaders reportedly stepped down, following far-reaching layoffs earlier in April that completely cleared out the office’s Division of Promotion Policy, Research and Operations, among other impacted teams.
Without the appropriate bandwidth to continue policing drug ads, Durbin wrote that he is “concerned that any gap in regulatory oversight would provide an opening for unscrupulous behavior by industry stakeholders eager to promote medications absent FDA scrutiny.”
As one example of potentially troublesome marketing that may have already flown under the radar, he pointed to language on the Hims & Hers website related to its new partnership with Novo Nordisk to sell its GLP-1 drug Wegovy.
“There appear to be promotions on the telehealth company’s website that may be considered advertisements for off-label uses of the drug and also may fail to adhere to FDA’s requirements for providing a ‘fair balance’ of risk information, given the limited safety disclosure that is buried in the text and only accessed via an external link,” the senator suggested.
Durbin concluded his letter to Makary with a list of four questions, the answers to which he requested by June 17.
The questions ask about the current leaders and headcount at the OPDP; seek further information about the recent layoffs and how they might affect the office’s output in 2025 compared to last year; and request confirmation that the OPDP will “obligate its Fiscal Year 2025 funding.”
The letter represents the latest piece of Durbin’s long-running work to rein in drug advertising.
Just this year so far, the Senate’s second-highest-ranking Democrat has joined other senators in re-upping an oft-attempted call to add price disclosures to all prescription drug ads and also expanded an ongoing probe into drugmakers’ direct-to-consumer telehealth platforms and their partners.