This Week at FDA: Anti-abortion groups want Makary fired, FDA investigating COVID-19 and RSV vaccines

Editor's Note: A previous version of this article erroneously stated CBER was investigating the safety of RSV vaccines; CBER is reportedly investigating RSV antibody therapies. Regulatory Focus regrets the error.

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, anti-abortion groups called for FDA Commissioner Marty Makary’s resignation after reports he was slow walking a safety review of mifepristone, the agency is investigating potential COVID-19 vaccine-related deaths across age groups, and reviewing respiratory syncytial virus (RSV) treatments.

Conservative and anti-abortion activists have been trying to push the Food and Drug Administration (FDA) to withdraw its marketing authorization that allows mifepristone to be available by telemedicine and mail order, arguing the drug hasn't been proven safe. Earlier this year, HHS Secretary Robert Kennedy Jr. and FDA Commissioner Marty Makary said they would initiate a safety review of the drug. This week, Bloomberg News reported that, according to sources, Makary has been delaying the review until after the 2026 midterm elections.

After the news broke, Makary came under attack from groups including Susan B. Anthony Pro-Life America, which called for his ouster.

The White House, however, has come to Makary's defense. According to The Hill, the administration said that the calls for his sacking were "uninformed attacks" and that it has "the utmost confidence in Commissioner Makary." It also insisted the review was not being held up.

After Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER), recently claimed that the COVID-19 vaccine has killed at least 10 children, CNN reported that the FDA is investigating whether there have been deaths from the COVID-19 vaccines "across multiple age groups." While the agency stated that it was conducting a thorough investigation, it did not specify the data sources being examined.

Reuters reported that the FDA has informed Merck, Sanofi and AstraZeneca that it is reviewing their respiratory syncytial virus (RSV) monoclonal antibodies (mAb). The move comes after vaccine skeptics raised concerns that treatments were not properly vetted for safety.

CBS News reported that last week's appointment of Tracy Beth Høeg as acting director of the Center for Drug Evaluation and Research (CDER), following the departure of Richard Pazdur and George Tidmarsh, has raised concerns among top FDA officials and others due to her reputation as a vaccine skeptic.

"Putting Tracy Beth in charge is like dropping an atom bomb," one agency source told CBS News, adding that multiple top-level officials are preparing to resign. "It's an extinction-level event. Tracy Beth Høeg has never supervised a drug review, never has conducted a clinical trial. She doesn't understand laws and regulations."

FDA asked for public feedback, including from patients and consumer advocacy groups, as it negotiates with the biosimilar industry to reauthorize the Biosimilar User Fee Act (BsUFA). The agency said it intends to commence monthly stakeholder meetings to renegotiate a BsUFA deal starting April 2026, and the public can submit their intent to participate in the meetings through 30 January 2026.

Drugs &Biologics

An FDA-panel has recommended easing restrictions on testosterone replacement therapy (TRT) for men, and has issued arequest for information (RFI) to get public feedback on the topic. The agency said the docket will remain open until 9 February 2026 for comments and posed questions, such as the potential impacts on certain diseases and conditions from TRT.

Gamida Cell's drug Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat severe aplastic anemia (SAA), has received FDA approval. The agency noted that the drug is indicated for patients 12 years and older with hematologic malignancies and is now also approved for patients six years and older with SAA after reduced intensity conditioning and who can't find a compatible blood donor.

In another first, Fondazione Telethon ETS's Waskyra (etuvetidigene autotemcel) was approved by FDA as the first cell-based gene therapy to treat Wiskott-Aldrich syndrome (WAS) in patients six months and older with the WAS gene for whom hematopoietic stem cell transplantation (HSCT) is appropriate and no suitable human leukocyte antigen (HLA)-matched related stem cell donor is available.

USAntibiotics's antibiotic Augmentin XR (amoxicillin-clavulanate potassium) was the first drug approved by FDA under the Commissioner's National Priority Voucher (CNPV) pilot program. The agency noted the drug was approved in only two months after it demonstrated that it would bolster domestic manufacturing and address the US' antibiotic shortage.

FDA proposed an order that would permit bemotrizinol to be added as an active ingredient to sunscreens. The agency said the proposal was part of its efforts to advance sunscreen innovation and its review of data supported the proposal.

As part of its Drug Development Tool (DDT) Biomarker Qualification Program (BQP), FDA qualified the Artificial Intelligence (AI)-Based Histologic Measurement of MASH (AIM-MASH) as the first AI DDT. The agency said that pathologists can use the tool to assess metabolic dysfunction-associated steatohepatitis (MASH) disease activity in clinical trials by scoring liver biopsy components, including fat infiltration (steatosis), inflammation (hepatocellular ballooning and lobular inflammation), and scarring (fibrosis) stages.

Medtech

The Center for Devices and Radiological Health (CDRH) provided an update stating that the number of devices enrolled in its Total Product Lifecycle Advisory Program (TAP) pilot has increased to 106. The pilot is part of the Medical Device User Fee Amendments (MDUFA V) deal the agency struck with industry to allow early sponsors early engagement with the agency and external stakeholders such as insurers and patient advocacy groups during medical device and diagnostics development.

David McMullen, former director of the Office of Neurological and Physical Medicine Devices at CDRH, has joined Elon Musk's brain implant company Neuralink to lead its medical affairs division, according to Reuters. At FDA, he was responsible for the review of devices such as Neuralink's brain implant.

Fierce Biotech reported that FDA has approved Flow Neuroscience's wearable brain stimulation headset, FL-100, as the first at-home, non-drug therapy for depression. It noted that the device can be used as both a standalone treatment or in combination with other medications.

FDA approved the first generic version of Imvexxy (estradiol vaginal inserts), which it said gives women more options to treat moderate to severe dyspareunia (painful sexual intercourse), a symptom of vulvar and vaginal atrophy, due to menopause. The agency said the insert is intended to deliver a low dose of estradiol directly to vaginal tissue.

This Week at FDA: Anti-abortion groups want Makary fired, FDA investigating COVID-19 and RSV vaccines

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