This Week at FDA: Nomination hearings, FDA lease cancellations, and more

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, President Trump’s picks to lead FDA and the National Institutes of Health (NIH) appeared before the Senate committee tasked with reviewing their nominations.

The Senate Health, Education, Labor, and Pensions (HELP) Committee held nomination hearings this week to hear testimony from Martin Makary and Jay Bhattacharya, Trump’s nominees for FDA commissioner and NIH director, respectively. Both nominees have a history of challenging mainstream scientific opinions, including during the COVID-19 pandemic, when both were critical of certain public health measures such as masking in schools and vaccinations for children.

On Thursday, Martin Makary, a Johns Hopkins surgeon, told the senators that, if confirmed as FDA commissioner, he would commit to investigating several controversial issues, including access to mifepristone, a canceled flu vaccine advisory committee meeting, the agency’s personnel needs, and a recent clinical trial diversity guidance. He also said he wants to follow the science and apply a commonsense approach in his decision making.

"I do believe firmly in that approach, and I think we can use some common sense to ask some big questions we've never asked before at the FDA,” said Makary.

Makary also said regulators need to ask questions such as why a drug should require a prescription if it can be sold over-the-counter and why products such as continuous glucose meters (CGM) need to be prescribed by physicians when they can be used by anyone to potentially prevent pre-diabetes.

“Why are we holding these tools that help people to empower them with knowledge about their health until after they're sick,” said Makary.

On Wednesday, Jay Bhattacharya, a Stanford University professor, testified before the HELP committee about his qualifications to become the next NIH director. Several Republican senators praised Bhattacharya for speaking out against mask mandates and lockdowns during the pandemic.

During the pandemic, Bhattacharya advised states, such as Nebraska and Florida, on lockdowns and whether to allow children to go back to school in ways that contradicted advice from federal public health officials. Sen. Pete Ricketts (R-NE) said Bhattacharya showed "great intellectual honesty and courage" during the pandemic and is someone who understands the scientific method. Similarly, Sen. Ashley Moody (R-FL) praised Bhattacharya’s decision to go contrary to popular scientific opinion.

"It was so refreshing for me to be able to speak my scientific views in Florida during the pandemic,” said Bhattacharya. “The root problem is that people who had alternative ideas were suppressed.” He also claimed that he was censored by the Biden administration.

“For science to succeed, it needs free speech,” said Bhattacharya. “It needs an environment where there is tolerance for dissent, and the reason I think Florida did so well is that it provided an outlet for that dissent so that the state of Florida could adopt the best ideas.”

If confirmed, Bhattacharya said he would implement five goals, including establishing a culture of respect for free speech in science and scientific dissent. He said that over the past few years, top NIH officials have overseen a culture of cover-up, obfuscation, and lack of tolerance for ideas that differed from their own.

“I will foster a culture where NIH leadership will actively encourage different perspectives and create an environment where scientists, including early career scientists and scientists that disagree with me, can express disagreement respectfully,” said Bhattacharya.

Bhattacharya said he would focus NIH research on solving the chronic disease crisis and recommit to its mission to fund the most innovative biomedical research agenda possible to improve American health. He also said he wants to focus funding on issues such as population aging and obesity.

“My plan is to ensure the NIH invests in the most cutting-edge research in every field to make big advances rather than just small incremental progress over the years,” he said.

Bhattacharya said NIH must also regulate risky research that could possibly cause a pandemic. Some republicans have suggested that gain-of-function research on coronaviruses, including research supported by NIH, contributed to the COVID-19 pandemic. While the exact origin of COVID-19 and the source of its emergence in humans remains unknown, the “lab leak” theory has gained traction in some circles, though the global scientific consensus is that the virus is of animal origin.

“[NIH] must embrace transparency in all its operations,” said Bhattacharya. “While the vast majority of biomedical research poses no risk of harm to research subject or the public, the NIH must ensure that it never supports work that might cause harm. If confirmed, I will work with Congress and the administration to guarantee that happens.”

Finally, Bhattacharya said that NIH-supported research should be replicable, reproducible, and generalizable. He said that much modern biomedical research fails that test.

Committee Chair Bill Cassidy (R-LA) asked Bhattacharya whether he thought vaccines cause autism, as he did when questioning Robert Kennedy Jr. during his confirmation hearing for HHS secretary.

"I generally don't think there is a link based on my reading of the literature … We do have a sharp rise in autism in this country, and I don't know, and I don't think any scientists knows the cause of it,” said Bhattacharya. “So, I would support a broad scientific agenda based on data to get an answer to that.”

Cassidy, however, noted that the potential link between autism and vaccines has been exhaustively studied, and he doesn't want NIH to keep spending money studying the issue.

“We've got a responsibility with limited resources,” said Cassidy. “My concern is the more we pretend this is an issue, the more we'll have children dying from vaccine-preventable diseases.”

Sen. Maggie Hasan (D-NH) criticized Bhattacharya for not explicitly stating that vaccines don't cause autism. She said the rising number of autism cases are due to better diagnoses of the disease and added that there's research that points to genetic issues and environmental factors that are likely causes. She also agreed with Cassidy that there is significant research to show that autism is not caused by vaccines.

"It disappoints me greatly that neither you nor the secretary now of health and human services are willing to say that declaratively and strongly,” said Hassan “What you do when you hesitate, what the secretary does quite cynically in my view when he hesitates about this, is you churn and sow doubt and worry at a time when we should be focused on actually finding the cause and the cure of autism."

Public Citizen wrote to senators on behalf of 47 public and health advocacy groups asking them not to appoint Trump's nominee for deputy secretary of HHS, Jim O’Neill, for harboring concerning views, including the view that FDA should approve drugs solely on safety and let patients decide if they are effective. Jim O’Neill was under consideration for FDA commissioner during Trump's first presidency and, according to reports at the time, was being lobbied for the position by Libertarian billionaire Peter Theil.

There has been much confusion this week about the Department of Government Efficiency’s (DOGE) decisions to end leases for at least 30 FDA offices around the nation, including a large laboratory in St. Louis where the agency does drug quality testing. However, days after the announcement, FDA and HHS confirmed to Focus that the 52,000 square foot St. Louis lab will remain open.

In other news, Medtech Strategist reported that FDA officials from the Center for Devices and Radiological Health would not be in Tokyo next week to meet with members of the International Medical Device Regulators Forum (IMDRF) in person during their annual spring meeting where global regulators discuss harmonizing regulations. According to sources, FDA officials will participate virtually in closed-door discussions during the meeting.

Since the Trump administration came to power, the number of significant meetings held by designated FDA policymakers with persons outside the federal government's executive branch has dwindled significantly. However, according to the agency's latest report, between 23 February and 1 March, the number of such meetings seems to be increasing. The report notes meetings between FDA policymakers and Medtronic CEO Geoff Martha, representatives of Chemours, and Andrew Fish, CEO of the Medical Device Innovation Consortium (MDIC). FDA policymakers also met with representatives of the Senate appropriations staff.

According to an email reviewed by Focus, Ross “Rusty” Segan, former director at CDRH's Office of Product Evaluation and Quality (OPEQ), was offered his job back after he was fired as part of the DOGE’s purge of federal probationary workers. However, Segan wrote to his former colleagues this week stating that despite appreciating their time working together, he has decided not to return to the agency.

“It is with heavy heart that I wanted to let you know I have decided not to return to CDRH after the recent probationary employee actions,” wrote Segan. “After much deliberation with my family and careful self-reflection, I have decided that I need to continue my service to patients and global public health in a different way.” Focus reached out to Segan for comment but did not get a reply as of publishing.

After retracting an email requiring federal workers to list five achievements from the previous week, DOGE again emailed workers through the Office of Personnel Management (OMP) to submit five achievements, but this time to include their manager. The emails are to be sent weekly and should not include sensitive information.

Reuters reported that HHS emailed workers on Monday informing them that they could apply for early retirement over the next 10 days. Employees were directed to OMP's website, which states that employees must be at least 50 years old with 20 years of federal service, or any age with 25 years of service to be eligible for voluntary early retirement.

Drugs & Biologics

Sen. Amy Klobuchar (D-MN) proposed a bill this week asking the Reagan-Udall Foundation to establish a process for science-focused drug development meetings to help develop drugs for rare diseases and conditions. Sen. Roger Wicker (R-MS) is co-sponsoring the bill, which has been referred to the Senate HELP Committee.

Medtech

The medtech lobby group, AdvaMed, published its priorities for the 119th Congress, which include reauthorizing the 2017 Tax Cuts and Jobs Act (TCJA), updating the 1996 Health Insurance Portability and Accountability Act (HIPAA) to allow more use of artificial intelligence (AI), and legislation to address the impact of budget neutrality on coverage and adoption of AI technologies. The group also said it wants exemptions and exclusions from Trump's tariffs and a new regulatory framework for in vitro diagnostics.

This Week at FDA: Nomination hearings, FDA lease cancellations, and more

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