RFK Jr. Taps Drug Chief From Revolving Door He Vowed to Close

The appointment of a seasoned pharmaceutical executive, George Tidmarsh, to run the FDA’s drug center underscores the challenge in closing a “revolving door” between the industry and government that Health Secretary Robert F. Kennedy Jr. promised to slam shut.

Tidmarsh, who’s founded and held senior positions at several biopharmaceutical companies, was named this week the director of the Food and Drug Administration’s Center for Drug Evaluation and Research. The critical role oversees one of the agency’s largest and important divisions that regulates brand and generic drugs.

The agency’s pick appears to take a back seat to the health department’s efforts to tighten up the government’s relationship with pharmaceutical companies, industry watchers say, despite a touted agenda that seeks to limit conflicts of interests and close a revolving door where individuals transition between regulatory roles and the industries they oversee.

Kennedy has repeatedly said he will put an end to the revolving door, while FDA Commissioner Marty Makary has called on the need for drug approvals and scientific evaluations to be independent of the industry.

“We have this new leadership talk about the importance of closing the revolving door at FDA and mitigating and minimizing industry conflicts of interest, but appointing somebody like this is not necessarily doing that,” said Reshma Ramachandran, an assistant professor at Yale School of Medicine.

“This is somebody who knows the business,” Ramachandran added. “But the question is, do you need that person at FDA in order to get that viewpoint when FDA already gives privileged access.”

Tidmarsh’s portfolio includes leading successful clinical developments of seven FDA-approved drugs. He’s the founder of Threshold Pharmaceuticals, Metronome Therapeutics, and Horizon Therapeutics, which was eventually acquired by Amgen Inc. He was the CEO at Solana Therapeutics and La Jolla Pharmaceutical Co. In May, he stepped down from Revelation Biosciences’ board of directors.

It’s not uncommon for individuals that work in regulated companies to join the FDA, or for regulators to enter the industry after serving the government. But each exit and entry almost always raises questions on biases and decisions made. Kennedy, a longtime critic of the pharmaceutical industry, claimed it results in favorable treatment to corporations and behind-the-scenes coordination.

One of the latest regulators to go through it was Patrizia Cavazzoni. The former CDER director held several senior executive positions in the industry prior to joining the FDA and rejoined Pfizer Inc. in February after departing the agency following President Donald Trump’s return to the White House.

Former Commissioner Robert Califf left to work at Verily Life Sciences before returning to the agency under the Biden administration, and Scott Gottlieb, commissioner during Trump’s first term, now serves on the boards of Pfizer and Illumina.

An HHS spokesperson said the department supports Tidmarsh’s appointment and he stepped down from all industry roles to comply with ethics and conflict of interest rules. The department confirmed that Kennedy is still committed to ending the revolving door and “ensuring that regulatory decisions are guided by public health, not corporate influence.”

‘Creature of Industry’

Hiring Tidmarsh departs from Makary’s efforts to end a “cozy relationship” between companies and the government, industry watchers say.

Makary in April introduced a policy that limits industry employees in FDA advisory committees to mitigate perceived industry influence and conflicts of interest. That same month, he said his team was weighing options to stop regulators from leaving the agency to go on to work for the industry, but noted it’s a “free country.”

“Pharma might be encouraged that he has a lot of experience in drug development,” said Genevieve Kanter, a professor at the University of Southern California, but the “concern with Tidmarsh is that he has had no regulatory or FDA experience, unlike previous CDER directors and Gottlieb.”

“His background doesn’t seem to reflect any prior interest or work in public service, so I think it’s fair to be concerned that his sources of information may be biased in a way that might not always favor public interests,” said Kanter, who published a study that shows about 12% of FDA appointees come from industry.

The agency could have “found a highly qualified candidate who was not a creature of industry” to mitigate this concern, said Robert Steinbrook, health research group director for Public Citizen.

One of Makary’s top advisers, Vinay Prasad, is also critical of the revolving door, claiming prior to becoming the FDA’s vaccine head that it’s “why the agency works for pharmaceutical interests.”

Still, it remains to be seen how Tidmarsh’s pharmaceutical background will influence his leadership.

“Tidmarsh’s stances have mainly favored industry,” said Adriane Fugh-Berman, a pharmacology professor at Georgetown University. “He certainly is an iconoclast.”

Positive for Industry

Appointing a pharmaceutical veteran has proved successful in the past, industry advocates say.

“It is advantageous to have a regulator with comprehensive knowledge of drug development,” said Rachel Turow, head of FDA regulatory practice at Skadden Arps Slate Meagher & Flom LLP.

Tapping Tidmarsh is also beneficial because he encompasses perspectives of the industry and regulatory requirements, others say.

“As CDER director, he has to walk a very fine line as both regulator of and colleague with drug developers,” said Peter Pitts, a former FDA associate commissioner, now co-founder of the Center for Medicine in the Public Interest. “The fact that he understands the perspective from the other side of the desk is crucial.”

Friends of Cancer Research said Tidmarsh’s perspective as a former treating physician brings a valuable understanding of patients’ needs to the agency. The Association of Accessible Medicines said it looks forward to collaborating with Tidmarsh to ensure lower-cost generic and biosimilar medicines are available for patients.

“There are always concerns about pro-industry bias if a government appointee comes straight from the industry that he is now asked to regulate,” Kanter said. “But just because someone comes from pharma doesn’t mean that they will make policy choices that aren’t in the interest of the public when they’re in government service.”