This Week at FDA: Moderna flu vaccine refused, former FDA official joins lobby group, 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, Moderna announced FDA has refused to file its application for a new influenza vaccine – reportedly at the direction biologics head Vinay Prasad – and a former top FDA official has left the agency to work for the device industry group AdvaMed.In a controversial move, Prasad, director of the Center for Biologics Evaluation and Research (CBER), reportedly overruled career staff to refuse to review Moderna’s application for its mRNA influenza vaccine. Early in the week, Moderna reported that FDA had notified it that it would not review its application in a refusal-to-file (RTF) letter, despite an agreement with the agency in 2024 on its vaccine development plan. The company said Prasad argued that its study was inadequate and lacked a well-controlled design based on the best available standard of care. More specifically, it said that its use of a licensed standard-dose seasonal influenza vaccine comparator was the sole reason for its rejection.
Several news outlets reported on the unusual move, including The Wall Street Journal, which said Prasad overruled career staff objections to rejecting Moderna's vaccine application, including the risk of facing litigation. According to sources, the CBER director also told staff that he would like to issue more RTF letters so he can reject them before the agency has to evaluate the applications.
The Wall Street Journal also reported that Prasad is facing multiple complaints from staff, including allegations of sexual harassment, retaliation against subordinates, and verbal abuse.
In related news, FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to convene its panel of external experts on 12 March to discuss and recommend the strain composition of influenza virus vaccines for the 2026-2027 influenza season. The composition of the panel is controversial, as Health and Human Services (HHS) Secretary Robert Kennedy Jr. reconstituted it last year, appointing several known vaccine skeptics.
The boxed warning for six hormone replacement therapy (HRT) drugs used to treat menopause symptoms will no longer require cardiovascular disease, breast cancer, and dementia risk statements, according to FDA. The agency announced that it had approved labeling changes for the menopausal hormone therapy drugs following a request from 29 drug companies and a review of the scientific literature.
FDA has issued a request for information (RFI) to receive public feedback on whether butylated hydroxyanisole (BHA), a food preservative, is safe under current usage conditions and scientific knowledge. The agency said it was part of its overall efforts to review food additives in the food supply chain.
FDA published several guidances this week, including reissuing a draft guidance on the certification process for designated medical gases (DMG). The agency noted that the guidance was reissued to align with new regulations that went into effect in December, including additional information on what sponsors need to submit, changes to already granted certifications, annual reports, the withdrawal and revocation of approval process, and labeling requirements.
FDA also issued a draft guidance on antimicrobial drugs used for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) that are important to humans, used for feed for food-producing animals, and that are currently approved with one or more indications that have an undefined duration of use. The agency said the guidance is intended to mitigate antimicrobial resistance.
Drugs & Biologics
Merck's Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab with berahyaluronidase alfa-pmph) in combination with paclitaxel, with or without bevacizumab, was approved by FDA to treat adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) diagnosed with an FDA-authorized test, and who have received one or two prior systemic treatment regimens. The agency simultaneously approved Agilent Technologies' PD-L1 IHC 22C3 pharmDx companion diagnostic to identify patients who may be candidates for the treatment.
Volunteers can start applying for FDA's Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program. CBER announced there are limited spots for the third year of the voluntary program that allows drug manufacturers to learn more about their assessment tool and process.
The FDA has approved modifications to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program for isotretinoin manufacturers. The updated REMS goes into effect on 8 August and includes changes to how patients can take pregnancy tests and how their healthcare providers can allow for the tests.
FDA issued consumer safety alerts warning people not to buy several male enhancement products sold online, which it said contain undisclosed ingredients that have not been evaluated by regulators for safety and effectiveness. Three of the products, ilum, Rhino Choco, and Pink Pussycat Aphrodisiac contain tadalafil, the active ingredient in Cialis, and Boner Bears contains sildenafil, the active ingredient in Viagra.
Medtech
AdvaMed’s Janet Trunzo has officially retired after 30 years as one of the most powerful lobbyists in the medtech industry. AdvaMed announced last year that Trunzo was retiring, and this week the organization issued a statement that Melissa Torres has been named the new executive vice president of technology and regulatory affairs after serving at the FDA for the past 20 years in leadership positions, most notably in helping craft the agency's international regulatory policies.
Novocure's Optune Pax, a portable and non-invasive device that delivers alternating electrical fields, was approved by FDA as the first-of-its-kind device to treat adults with locally advanced pancreatic cancer. The agency said the devices use tumor-treating fields (TTFields) to disrupt the rapid cell division characteristic of cancer cells.
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