Pharma lobbyists focus on a surprising new target: the FDA
WASHINGTON — Health secretary Robert F. Kennedy Jr. has repeatedly promised to root out industry influence from the Food and Drug Administration.
But the Trump administration’s injection of political priorities into the agency, which has long been shielded from such meddling, has opened new avenues for lobbying. The pharmaceutical industry is working to capitalize, according to 10 people, including lobbyists, advisers, FDA officials, and an executive involved in the efforts.
“The nature of the relationship is so drastically different now,” Michael Abrams, a managing partner at Numerof and Associates who works with pharmaceutical clients on regulatory requirements, said of the interactions between companies and the administration. Abrams said the new system, under Trump, makes discussions about FDA decisions that once would have been “heretical” the new norm.
Companies pressuring the FDA to make favorable decisions is not new. Biogen, for example, famously lobbied senior FDA officials to approve its controversial Alzheimer’s drug. But the approach is becoming more common and more blatant. It’s reaching beyond the FDA as companies work to sell the White House or senior health department leaders on how a decision — or company’s success — can be spun as a win for the Trump administration, according to four people involved in the strategies.
Health department spokesman Andrew Nixon said in a statement that FDA decisions “are driven by gold-standard science, not outside influence.”
“The agency continues to work with industry as part of its regulatory role, while maintaining strong safeguards to protect scientific integrity and put patients first,” he said.
The FDA’s flip-flop on Moderna’s application for its new flu shot seemed to only confirm the wisdom of the new strategy, one of the lobbyists said. FDA leaders told Moderna earlier this month that it would not review the application.
Then, Moderna lobbyists reached out to the White House to complain about the decision, according to two people familiar with the matter. The FDA reversed course, and said it would review the shot. Politico and CNN later reported that the reversal came after White House intervention. A White House spokesman denied any involvement in the reversal.
The top-down approach has been on full display in a new, speedy drug review program. The White House has used this program to reward companies that align with its policy goals, such as lowering drug prices. For example, the White House offered EMD Serono a speedy drug review and dropped tariffs in exchange for the company lowering the prices of its fertility drugs.
Eli Lilly has also pointed to its connection to the White House to ask for preferential treatment from the FDA. The company agreed to lower the prices of its blockbuster weight loss drugs, and received three vouchers for speedy drug reviews in exchange.
During FDA meetings related to the pending review of its multidose injector GLP-1 drug — which did not receive a voucher for a faster review — Lilly officials repeatedly referenced its drug pricing deal to push for a quicker approval decision, four FDA officials told STAT. The commissioner’s office also repeatedly checked in on the status of the decision, the officials said. The FDA ultimately approved the multidose injector products, called the KwikPen, last month.
“We support the FDA taking the time it needs to conduct thorough and diligent reviews of all submissions and are pleased that our KwikPen presentation was approved,” Jared Shapiro, a Lilly spokesperson, said by email.
Health department spokesperson Emily Hilliard said the decision to approve Lilly’s product “reflected the consensus of the primary review team of career agency scientists.”
Lobbying the Trump administration
Lobbyists involved in the broader FDA influence efforts across the sector say they’ve seen a marked shift over the last year. Regulatory affairs plans that were once largely technical, focusing on drug trial design and regulatory minutia, have an added political strategy that focuses on an approach to the White House and top levels of the Department of Health and Human Services, according to the lobbyists.
“It was always the case: if it’s FDA, leave it alone,” one of the lobbyists, granted anonymity to discuss confidential meetings, told STAT. “There’s been a swing. … Now the conversations are: Can we influence the process? I had never had that conversation before.”
A second lobbyist said the new strategies are often “about currying favor” with top administration officials. “A lot of the FDA work is driven by the White House,” they said.
The Trump administration’s top-down approach to policymaking is no secret, nor is the White House’s willingness to make confidential deals with industry.
“People are coming here because they realize the White House is very firmly in charge,” one White House official told STAT, emphasizing that the new engagement with industry wasn’t impacting the scientific basis of agency decisions. “People see their best bet is coming to the White House. But it’s still a bad bet.”
One risk is that closed-door, political conversations impact how regulators determine which drugs are worthy of the American market, undermining the perception that the FDA makes sure drugs are safe and effective.
“If you’re a patient, you want to make sure that the drug has been approved on the basis of the best available data, and not because the CEO is a friend of someone important or made campaign contributions,” said Sarah Despres, a former senior counselor at HHS who oversaw the FDA under the Biden administration.
The shift has come despite Kennedy’s promises to eliminate industry influence in federal health agencies. Kennedy often argues that a federal health care bureaucracy compromised by pharmaceutical firms is to blame for Americans’ illnesses.
“[The FDA] was owned by big pharma and big food, and Marty Makary has changed that now,” Kennedy said on a podcast last week.
The lobbying extends to federal lawmakers. Companies will press them to reach out to the FDA in the hopes they may raise an issue with Trump or his top deputies. An FDA official told STAT that Congressional inquiries related to specific drug applications have ramped up under FDA Commissioner Marty Makary’s leadership.
“You would hear that every once in a while beforehand, and we would usually be able to be like ‘Congress, we can’t speak to application-specific issues,’” said the official, who was not authorized to speak publicly. “It’s become a pretty frequent drumbeat of inquiries from the Hill on all aspects of decisions.”
Lawmakers were invited to a meeting with FDA officials about expanding the approval of a drug made by billionaire Patrick Soon-Shiong’s ImmunityBio, Bloomberg reported in December. Soon-Shiong has lobbied the Trump White House directly to expand the cancer drug’s approval.
A company that recently received an unfavorable decision from the FDA, Disc Medicine, hired its first lobbying firm in January. Capitol Counsel will lobby lawmakers about “FDA approvals for rare diseases.”
Included in the new playbooks, two of the lobbyists said, are political firms that have little experience on the technical details of FDA regulations — but are tied to Trump’s inner circle.
Three firms close to the White House together took in nearly $11.7 million from pharmaceutical companies in 2025, compared to $2.2 million in 2024.
Overall lobbying spending in the pharmaceutical sector grew from $391 million in 2024 to $452 million in 2025, the largest single-year increase on record, according to data from OpenSecrets. And industry groups have also spent big on messaging tailored to the administration: PhRMA is spending seven figures on a campaign promoting American dominance in biopharmaceutical innovation, according to a person familiar with the campaign.
‘New avenues’
Historic turbulence at the agency has contributed to the new opening to exert top-down pressure over the agency, lobbyists believe, because power in the health agencies has shifted dramatically to political appointees, who usually seek to please the White House.
At the FDA, longtime experts have been pushed out and overruled in crucial decisions. Officials have been dismissed and then brought back. And career scientists have time and again expressed horror at what they say is long-term damage being done to a cornerstone of America’s health system. In response, FDA leaders have tried to soothe concerns about political influence at the agency.
“A weakened FDA commissioner in the eyes of the White House means new avenues,” one of the four lobbyists told STAT. “[Industry representatives] have gone to the White House and said: It’s been a year, and we still don’t have a sense of security about FDA, and it’s time for you to get involved.”
But it’s unclear, the person said, whether the strategies have worked thus far. Uncertainty still remains the driving force in industry’s relationship with the FDA, especially after highly unusual decisions. In November, scores of leaders in the sector sent an open letter to Makary voicing their concerns about the agency’s instability and fears it wouldn’t be able to effectively do its job.
Lobbyists emphasized that companies weren’t looking to push substandard products, and said they instead want to shore up applications that they fear won’t get a fair shot at approval.
Some have argued the industry has not been forceful enough in advocating for federal health care agencies. Rep. Jake Auchincloss (D-Mass.), who represents a Boston-area district full of biopharma companies, said the industry faced a classic prisoner’s dilemma. They could have worked together to lobby for a more stable HHS and FDA, or gone off on their own to make individual deals.
“What do they do?” Auchincloss told STAT. “They defect one by one. One by one they walked over to the White House. It was a failure by the industry to do that.”
Heightened industry engagement — despite promises from Trump and Kennedy alike to “drain the swamp” — has been welcomed by some officials.
Mehmet Oz, the administrator of the Centers for Medicare and Medicaid Services, told leaders of industry group PhRMA this week that convening industry and government leaders was the administration’s “secret weapon,” noting that private conversations with pharmaceutical executives were beneficial to the industry and government alike.
Stephen Ubl, the CEO of PhRMA, told reporters the industry’s worries around the FDA continued, though he said the industry group hadn’t changed its approach to engaging the agency and other interested parties, including in Congress and the White House.
“We have had concerns about the scale of change at the FDA, the loss of key staff,” he said. “We’re going to try to raise those concerns.”
By: Daniel Payne and Lizzy Lawrence
Source: STAT News