Health Secretary Robert F. Kennedy, Jr. voiced strong support for the Food and Drug Administration (FDA) and its Commissioner Marty Makary on Apr. 17, addressing criticism directed at the agency by members of Congress and parts of the pharmaceutical industry.
Kennedy’s remarks came during a Ways and Means Committee hearing where Rep. Darin LaHood questioned him about what he described as “mismanagement and bungled drug reviews” at the FDA that could negatively impact investment in new medical treatments.
In response, Kennedy defended the agency’s recent decision to reject Replimune’s advanced melanoma drug RP1, saying, “Marty made the correct decision to not approve that drug.” He explained that all FDA panels reviewing RP1 found it ineffective and noted that Replimune had submitted data from a single-arm trial rather than conducting a randomized study as requested by regulators. "All the people who were tested also received a chemotherapy drug, so we don’t know what the effect [of the investigative drug] was," Kennedy said.
Kennedy also addressed public backlash against Makary following media reports criticizing his leadership after RP1's rejection. He attributed this criticism to industry influence: “The industry’s so powerful. They own Congress, they own the media, and they can beat up Marty Makary because he’s trying to do change over there.”
BMO Capital Markets analysts supported the FDA's stance in communications with investors following Replimune's second rejection, stating that previous resubmission efforts appeared based more on hope than regulatory alignment: “Hope is never a winning strategy, unfortunately.”
Kennedy further claimed that under his leadership alongside Makary's tenure at FDA, "every record for drug approvals" had been broken with 67 new drugs approved. According to FDA records cited by Kennedy during his testimony, there were 46 novel drugs approved in 2025 along with additional biologics.
