This Week at FDA: Kennedy warns of ‘Deep State’ in FDA address, some FDA reviewers granted limited telework

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, the heads of the Department of Health and Human Services (HHS) and FDA laid out their vision to FDA staff, and some FDA staff were offered participation in a telework pilot.

On Friday, FDA Commissioner Martin Makary held a joint all-hands meeting to introduce HHS Secretary Robert Kennedy Jr. to agency staff. Focus has reviewed a transcript of the meeting, in which Makary repeated his past statements about the need for more collaboration and less territorialism between the different offices at the agency and for the agency to apply common sense in its decision making.

Makary also discussed some of FDA’s perceived shortcomings, including addressing chemicals in the food supply chain and insufficient efforts to reduce animal testing, though he tried to reassure staff that they had not done anything bad.

“No one diabolically thought, ‘I’m going to insist on animal testing,’ but it’s just been the way we’ve been doing certain things,” he said.

The day before the meeting, FDA announced that it wants to phase out animal testing requirements for monoclonal antibodies and other drugs with what it said are “more effective, human-relevant methods.” The agency said the new approach is intended to "improve drug safety and accelerate the evaluation process, while reducing animal experimentation, lowering research and development (R&D) costs, and ultimately, drug prices." (RELATED: FDA seeks to reduce animal testing requirements for mAbs, other drugs, Regulatory Focus 11 April 2025)

Kennedy repeated many of the same talking points he gave during his confirmation hearing, including the need to make science more transparent. He warned against being subsumed by orthodoxies and dictated by centers of power.

Kennedy also pushed President Donald Trump’s views that there is a “Deep State” at work but said that includes institutional pressures and powerful industrial interests. He also claimed, without citing any data, that there were fewer cases of obesity in children, autism, and autoimmune disease in the past, and urged FDA staff to focus on addressing chronic diseases.

According to FDA sources who spoke to Focus and were granted anonymity due to fear of professional reprisals, Makary and Kennedy’s presentations were streamed to the meeting, despite both of them being present at FDA’s White Oak campus. One source said they thought they didn’t have the meeting face-to-face with staff because “they’d get a bad reception.” Another source opined that they preferred to be surrounded by “yes people.”

Sources said they were also shocked by the fact that the secretary of health used a derogatory term for individuals with intellectual or cognitive disabilities when referring to people that he worked with in high school. The sources also said that Kennedy was given a tour of FDA’s laboratories after the meeting.

Sources earlier in the week also confirmed to Focus that despite the Trump administration’s return-to-office policy, the agency has started a telework pilot program for scientific reviewers who handle premarket submissions. According to an email reviewed by Focus, the pilot does not apply to reviewers who handle postmarket reviews and other work that is not funded by user fees.

Staff selected for the pilot program will be allowed to telework remotely up to two non-consecutive days a week but will also need to be flexible about coming into the office for sponsor meetings.

Two weeks after news broke that Kennedy had appointed David Geier, a known anti-vaccine advocate, to lead a study examining potential links between vaccines and autism, the health secretary announced during a White House cabinet meeting that the study would be completed by September.

Top Democrats in the House Energy and Commerce (E&C) Committee wrote to Kennedy this week expressing concerns about his decision to appoint Geier to study the causes of autism. Committee Ranking Member Frank Pallone (D-NJ), Diana DeGette (D-CO), and Yvette Clarke (D-NY) called him a conspiracy theorist and noted he’d been cited for practicing medicine without a license.

“We write to express our urgent concern with the Department of Health and Human Services’ (HHS’s) reported selection of a biased and discredited individual, Mr. David Geier, to lead a large, redundant, wasteful study retreading settled science on links between vaccines and autism spectrum disorder (ASD),” said the lawmakers. “Mr. Geier has been a central figure in a decades-long campaign of pushing falsehoods about vaccine safety, including a retracted study on the measles, mumps and rubella vaccine (MMR). Mr. Geier’s documented lapses in judgment, ethics, and expertise degrades the American people’s trust in reliable, science-based information to protect their public health.”

No Patient Left Behind (NPLB), a group of investors, medical manufacturers, and patient advocacy groups, wrote to the Senate Health, Energy, Labor and Pensions (HELP) Committee raising concerns about the recent mass firings at FDA. The group which, includes companies such as BioMarin, Thermo Fisher, and CRISPR Therapeutics, said they want the agency leadership to consider rehiring many of the workers.

“While we share a desire to strengthen and modernize the FDA, we are writing to share that we are deeply concerned about the current state of the agency and its future,” said NPLB. “Specifically, we worry that the institutional knowledge that makes the FDA the world’s leading regulatory body will be irretrievably lost due to the agency’s recent reduction in force and wave of retirements.”

“The agency’s ability to function is compounded by a hiring freeze,” the group added. “As a result, American patients, American industry, and American biomedical leadership will bear the consequences.”

Drugs & Biologics

The Government Accountability Office (GAO) issued a report noting that drug shortages were on its high-risk list, and since the start of the COVID-19 pandemic, the number of new drug shortages has decreased year-over-year, though drug shortages are lasting longer. The agency said that HHS has notified it that the drug shortage coordinator position would be terminated at the end of May 2025 due to the expiration of funding for the position.

"This will leave HHS without a mechanism for coordinating the department's drug shortage activities," GAO warned. "The department stated that the current administration had not indicated how it will direct and coordinate supply chain activities moving forward."

"Given the longstanding nature of this critical public health issue, it is important that HHS identify and implement a mechanism to coordinate its drug shortage activities and collaborate with other federal stakeholders," the agency added. "Once a mechanism is identified, taking into consideration GAO's leading practices for interagency collaboration when developing that mechanism will be critical to ensuring HHS can effectively address drug shortages."

Medtech

After sending markets into a tailspin over the past week, Trump announced a 90-day pause on tariffs that led to markets regaining some of their earlier losses. In response, Scott Whitaker, CEO of the medtech lobby group AdvaMed, posted on LinkedIn that the move encouraged them and said it restored short-term certainty to global markets.

"Moving forward, we will spend the next 90 days working with the President and his senior team to ensure the unique role of the medtech industry is protected, with the hope that the ultimate outcome is 'zero for zero' tariffs on medtech with all key trading partners," he added.

This Week at FDA: Kennedy warns of ‘Deep State’ in FDA address, some FDA reviewers granted limited telework

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