The pharma industry “own Congress, they own the media,” Health Secretary Robert F. Kennedy, Jr. told lawmakers by way of explaining the bad press against FDA Commissioner Marty Makary following the second rejection of Replimune’s advanced melanoma drug.
Health Secretary Robert F. Kennedy, Jr. came out in strong support of the FDA and Commissioner Marty Makary on Thursday, standing by the agency’s recent decisions and deflecting criticism of the agency toward the pharma industry.
During a much-anticipated congressional hearing with the Ways and Means Committee, Rep. Darin LaHood (R-IL) asked Kennedy about the “mismanagement and bungled drug reviews” at the FDA, which he said could “have chilled investments in life-saving, innovative cures.”
Kennedy, in response, brought up the recent rejection of Replimune’s advanced melanoma drug RP1, an oncolytic immunotherapy the agency had previously rebuffed in July 2025. “Marty made the correct decision to not approve that drug,” he told the lawmakers.
“Every panel within FDA who looked at the drug said it was not effective,” Kennedy continued, referring to career scientists at the agency. Replimune, according to the Secretary, was told to perform a randomized trial but instead insisted on submitting its application based on a single-arm trial. “All the people who were tested also received a chemotherapy drug, so we don’t know what the effect [of the investigative drug] was.”
The backlash against Makary—such as an April 14 article by The Wall Street Journal that blamed Makary and outgoing Center for Biologics and Research director Vinay Prasad for killing RP1 despite evidence of progress—is driven by the pharma industry, Kennedy claimed. “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.”
Notably, analysts at BMO Capital Markets also took the FDA’s side amid the pushback from Replimune’s second rejection.
“Commentary from the [complete response letter] clarify the consistency in FDA’s decision to deny approval,” the firm wrote to investors on April 11. It is clear from the communique, the analyst continued, that the company had never truly aligned with the FDA on the use of a single-arm study for RP1.
“We can’t help but feel prior resubmission efforts were grounded more on [Replimune’s] hope than true alignment with FDA,” the analysts added. “Hope is never a winning strategy, unfortunately.”
During the hearing on Thursday, Kennedy also claimed that the FDA under his and Makary’s leadership has “broken every record for drug approvals,” including 67 new drugs greenlit under his leadership, according to the Secretary.
According to the FDA’s records, there were 46 novel drugs approved in 2025, along with 21 new biologics, though one of the listed biologics is an automated plate for antiglobulin testing, while eight were different versions of a blood grouping reagent. In 2023, there were 55 new drugs and 20 new biologics for a total of 75 new approvals that year.
