This Week: FDA revokes LDT rule, Monarez warns about vaccine policies, Kennedy called to defend his decisions

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 FDA officially revoked a controversial rule to regulate laboratory-developed tests (LDT), the recently fired CDC director warned lawmakers about vaccine policy changes, and the Senate HELP Committee has asked the HHS secretary to defend his decision to have her fired.

A year and a half after publishing a much-anticipated rule regulating LDTs, FDA officially withdrew the rule after losing a court case in which the judge ruled the agency overstepped its Congressional authority. The agency said the final rule now reverts to language that existed in the regulation before the May 2024 final rule.

The recently fired former Director of the Centers for Disease Control and Prevention (CDC), Susan Monarez, told lawmakers that the public health system under the leadership of Health and Human Services Secretary Robert Kennedy Jr. and his anti-vaccine advisors is headed to a “very dangerous place,” according to the Associated Press. Monarez testified before a Senate Health, Education, Labor, and Pensions (HELP) Committee hearing about her disagreements with Kennedy and subsequent firing.

Her testimony was presented a day before the CDC's Advisory Committee on Immunization Practices (ACIP) met to discuss vaccine recommendations. The committee was recently purged and reconstituted with controversial Kennedy appointees. As CNBC reported, the panel commended weakening COVID-19 vaccine recommendations by advising that everyone receive the vaccine after consulting their physician.

The Hill reported that the panel also recommended delaying the administration of the vaccine for measles, mumps, rubella, and varicella (MMRV) until children are four years old. At the same time, however, the panel voted against aligning the recommendation with the Vaccines For Children federal program, which would have allowed children to receive the vaccine only if they were four years old and older.

After Monarez's testimony, HELP Chair Sen. Bill Cassidy (R-LA) announced he had invited Kennedy to speak before the committee as well. He said he intended to fulfill President Trump's mandate for "radical transparency" and give the HHS secretary a chance to share his side of the story.

FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) is slated to meet on 9 October to discuss the strain selection for the influenza virus vaccines for the 2026 Southern Hemisphere influenza season and recommend advancing the Center for Biologics Evaluation and Research’s (CBER) allergen standardization program. Stakeholders can comment on the topics by submitting statements to www.regulations.gov under docket no. FDA-2025-N-3657.

FDA will host a two-day public workshop starting 11 December entitled “Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development -- Leveraging Rare Disease Frameworks.” The agency said stakeholders will discuss common challenges and how to use rare disease product development frameworks to develop neonatal and rare disease products.

In its continued efforts to remove certain food dyes from the food chain, FDA proposed an order to remove the color additive regulation that allows manufacturers to use Orange B to color the casings or surfaces of frankfurters and sausages. The agency said that based on certification data, food manufacturers seem to have abandoned the coloring, and it has concluded that the regulation is outdated and unnecessary.

Former CEO and co-founder of quality system management software company Enzyme, Jared Seehafer, announced he has joined FDA as a senior advisor in the Office of the Commissioner. According to his LinkedIn profile, he joined the agency in August.

Drugs &Biologics

FDA published fee rates for drug and biologic applications for tropical diseases, rare pediatric diseases, or material threat medical countermeasures (MCM) priority review vouchers for the fiscal year 2026. The agency set the application rates at $1,962,472, which will stay in effect between 1 October 2025 and 30 September 2026.

The injectable version of Merck's cancer drug Keytruda, Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), was approved for patients 12 years and older to treat solid tumor indications that are already approved for the intravenous version of Keytruda. Keytruda is already the best-selling cancer drug in the world, and the injectable version is intended to be a faster and more convenient way to deliver the drug.

The Center for Research on Complex Generics (CRCG) and FDA will host a two-day hybrid workshop on 15 October to discuss regulatory oversight of artificial intelligence (AI) used in generic drug development and product lifecycle management. Organizers said the meeting will include presentations from regulatory scientists, industry leaders, and academic researchers, as well as question-and-answer panels.

FDA will host the two-day 8th Annual Advancing Generic Drug Development: Translating Science to Approval 2025 Virtual Workshop on 7 October. The agency will present information on how the Generic Drug User Fee Amendments (GDUFA III) Science and Research Program has affected generic drug development, regulation, and approvals.

FDA published its updated over-the-counter (OTC) Monograph Drug User Fee Program (OMUFA) arrears and paid facilities lists on its website. The agency also stated that, per President Donald Trump's Executive Order 14247 on modernizing payments, it will only accept payments in dollars through a US bank via electronic check, credit card, or wire transfer.

Medtech

The FDA issued two consumer safety communications this week, including a warning about the risks of using unauthorized infant monitors to measure and monitor vital signs such as heart or pulse rate, oxygen saturation, breathing or respiratory rate, and body temperature. The agency said OTC infant monitors are not authorized to monitor vital signs in infants and recommended using FDA-authorized devices.

Similarly, FDA warned that many OTC blood pressure devices do not have marketing authorization from the agency and recommended that consumers look for FDA-authorized devices for their health needs. The agency noted that unauthorized products could give inaccurate blood pressure measurements that lead to misdiagnoses, serious harm, and death.

Qualitative hepatitis B virus (HBV) antigen assays (product code LOM), HBV antibody assays (product code LOM), and quantitative HBV nucleic acid-based assays (product code MKT) were reclassified by FDA to class II devices with special controls from class III devices. The agency finalized the order that was first proposed in September 2024.

When FDA published a final rule in January 2023 on performance standards for diagnostic X-ray, laser, and ultrasonic products, it inadvertently deleted the previous version of the rule from the Code of Federal Regulations. The agency issued a notice stating that it has restored the previous language for posterity.

This Week: FDA revokes LDT rule, Monarez warns about vaccine policies, Kennedy called to defend his decisions

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