This Week at FDA: A second Trump term, RFK Jr., and what’s to come

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. There’s a lot to unpack from the past week – the election of Donald Trump to serve a second term as president has massive implications for both FDA and the regulated industry, though despite some incendiary comments about what’s to come, much remains to be seen about how the incoming administration will act.

While FDA and healthcare product regulation were not a major focus for much of the campaign season, public health came into sharper focus after Robert Kennedy Jr. ended his longshot independent bid for president and endorsed Trump in August, seemingly in exchange for a prominent position overseeing federal healthcare agencies.

“He’s going to help make America healthy again,” Trump said in his election night victory speech, after making comments last month about letting Kennedy “go wild on health.”

In an interview with MSNBC on 6 November, Kennedy sought to reassure that he would not be coming after vaccines, despite his lengthy record of vaccine denialism.

“No, I’m not going to take away anybody’s vaccines. I’ve never been anti-vaccine,” Kennedy told NBC. “People ought to have choice, and that choice ought to be informed by the best information. So, I’m going to make sure the scientific safety studies and efficacies are out there and people can make individual assessments about whether that product is good for them,” he said.

However, prior to dropping out of the presidential race, Kennedy said “there is no vaccine that is safe and effective” during an episode of the Lex Fridman Podcast last July.

Kennedy also suggested that he would make sweeping cuts at FDA. “There are entire departments – like the nutrition department at FDA – that have to go, that are not doing their jobs,” he told MSNBC. “I can get the corruption out of the agencies.”

In an X post just two weeks before the election, Kennedy promised to end “FDA’s war on public health,” listing various things he claimed are being aggressively suppressed by the agency. His list included some controversial products, including hydroxychloroquine and ivermectin, hyperbaric therapies, and chelation therapies, as well as “clean food, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma.”

“If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags,” he wrote.

That said, there is much uncertainty about what role – if any – Kennedy might play in the incoming Trump administration. So far, the Trump campaign hasn’t announced any cabinet-level nominations, nor has it offered any specifics on Kennedy’s presumed role, though there is some speculation that he could serve in an advisory capacity or be given a “czar-like position” that encompasses healthcare and environmental issues, CNN reports, citing concerns about Kennedy’s ability to gain security clearance. When asked whether he expects to be named to a Senate-confirmed position during an interview with NPR’s Steve Inskeep on Wednesday, Kennedy said “we have not yet decided exactly what that strategy is going to be, but that is a possibility.”

In either case, who Trump selects to run federal health agencies will have an impact on industry and public health, as STAT, Politico, and Roll Call report, and there will be much to learn in the coming months about Trump’s approach to various issues facing FDA and the regulated industry, including user fee reauthorization, FDA’s budget, and the agency’s approach to regulating laboratory developed tests (LDTs).

In statements issued on 6 November, both the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) issued statements expressing their desire to work with the Trump administration on public health matters.

Drugs & biologics

Last Friday, FDA warned consumers not to take drugs compounded by Fullerton Wellness, which produces drugs including the diabetes injections semaglutide and tirzepatide, which have become popular for weight loss. The agency said based on its observations of the compounder’s facility in Ontario, California, it is concerned about the sterility of the drugs.

On that note, Reuters reported this week that Novo Nordisk CEO Karsten Munk Knudsen told members of the media that the company is aware of 10 deaths among people taking compounded weight-loss drugs, apparently referring to 10 adverse event reports for compounded semaglutide that cited a death in the last two years. However, as Reuters points out, the adverse event reports “do not identify a cause of death” and that multiple reports could possibly be tied to a single incident.

Mark Abdoo, FDA associate commissioner for global policy and strategy, penned a blog post this week on the World Health Organization's (WHO) Member State Mechanism on Substandard and Falsified Medical Products. He highlighted the organization's need to prevent substandard products from coming to market and provided thoughts on improving its effectiveness, such as by improving member state regulatory workforces and promoting a whole-of-government regulatory mindset approach.

The Small Business & Industry Assistance (SBIA) office at the Center for Drug Evaluation and Research will hold a two-day meeting starting 9 April 2025, to discuss the development and approval of generic drugs. The agency said that the 2025 Generic Drugs Forum is primarily meant to help prospective and current generic drug sponsors learn about submitting complete and high-quality submissions.

The Cellular, Tissue, and Gene Therapies Advisory Committee will meet virtually on 21 November. The panelists will discuss and provide recommendations to FDA about AstraZeneca's BLA for Andexxa (coagulation factor Xa (recombinant), inactivated -zhzo), for patients who have been treated with rivaroxaban or apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

In collaboration with the Duke-Margolis Institute for Health Policy, FDA will host a hybrid meeting on 12 December to discuss its Real-World Evidence Program for drugs and biological products. The agency said it will highlight its accomplishments and opportunities while discussing challenges and potential next steps for using real-world data to develop products.

Medtech

The General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee voted 9-5 that the benefits of IceCure's ProSense cryoablation device outweighed its risks. The device is an alternative to surgically removing tumors and is intended to treat patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. IceCure notes that three of the panelists who voted against the device said they could be persuaded to vote for it if FDA required adequate special controls.

The consumer advocacy group Public Citizen submitted an amicus brief on behalf of itself and five other organizations in support of FDA's case against the American Clinical Laboratory Association (ACLA), where ACLA has sued the agency to prevent it from implementing a rule to begin regulating LDTs. The group argued FDA oversight of LDTs is warranted to ensure their safety and effectiveness.

Terumo's Rika Plasma Donation System received 510(k) clearance from FDA. The agency said the automated blood component collection system was substantially equivalent to its predicate device and is intended to separate whole blood into plasma and its remaining cells and saline, which are returned to the plasma donor.

FDA is hosting a presentation on synthetic data for medical imaging when developing artificial intelligence/ machine (AI/ML) learning products on 14 November. The presentation will be given by Elena Sizikova, a staff fellow at the Office of Science and Engineering Laboratories (OSEL), who will summarize and compare methodologies for creating medical synthetic data and explain the difference between knowledge-based (KB) and imaging-based models.

FDA provided an update on its Breakthrough Devices Program and noted that since its launch, it has granted the designation to 1,041 devices, including 1,029 granted by the Center for Devices and Radiological Health and 12 by the Center for Biologics Evaluation and Research. So far, 128 products with the designation have received marketing authorization.

This Week at FDA: A second Trump term, RFK Jr., and what’s to come

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