This Week at FDA: FDA to scrutinize co-administered vaccines, new CRLs, and a GLP-1 ‘Green List’

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, tucked away in a decisional memo, FDA’s biologics chief said he will require randomized controlled trials (RCTs) for claims about concurrent administration of vaccines. The agency also published dozens of recent complete response letters (CRL), and it created a new list meant to curb unverified foreign GLP-1 active pharmaceutical ingredients (APIs) from entering the country.

Agency IQ reported that, according to a 26 August memo from Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad, in which he disagreed with certain aspects of the review team’s findings, FDA will start requiring RCTs to support claims related to concomitant vaccine administration, such as concurrent COVID-19 and influenza vaccines given together. In the memo, Prasad raised doubts the practice of concurrent vaccine administration, writing that without randomized trials, “FDA cannot affirm that concurrent administration is both safe and effective.”

“CBER OCD will require pragmatic, randomized controlled trials, randomizing persons eligible for multiple vaccines to concomitantly administer them in a single session, or to administer some sequence of the vaccines,” said Prasad. “The trial could be performed with a hierarchical statistical design, testing first noninferiority and then superiority.

“The primary endpoint would be clinical, for instance: symptomatic RSV, COVID-19, and influenza,” he added. “Secondary endpoints would be severe disease, and adverse events.”

HHS Spokesperson Andrew Nixon also elaborated on the matter to the Washington Post and said that FDA would announce a new framework for co-administered vaccines.

FDA announced it will publish complete response letters (CRLs) detailing the reasons for a product’s rejection soon after they are issued to drugmakers. The agency also released a batch of 89 CRLs for products that have been rejected since 2024 and are no longer being pursued by their sponsors. FDA said the action is part of its effort to promote "radical transparency" and clarify the reasons behind rejecting certain drugs, though some experts have raised concerns about the legal consequences of releasing the documents.

Health and Human Services Secretary Robert Kennedy Jr. clashed with lawmakers during a Senate Finance Committee hearing over his controversial vaccine policies and the recent firing of the director of the Centers for Disease Control and Prevention (CDC). Several Democratic senators called for Kennedy's resignation during the meeting, where they accused him of lying. Kennedy also accused lawmakers of lying and argued he was purging the agency of officials with alleged conflicts of interest and poor judgment.

The Wall Street Journal reported that Kennedy is expected to announce that the use of Tylenol (acetaminophen) during pregnancy and low folate levels, a form of B vitamins, are likely causes of Autism. HHS is expected to publish a report on causes of autism that Kennedy has touted for months, and according to sources, the report is expected to recommend medicines derived from folate as a treatment for symptoms of the developmental disorder.

Florida Surgeon General Joseph Ladapo and Governor Ron DeSantis announced this week that the state would eliminate its vaccine mandates and instead would make them optional for millions of its school-aged children and college students. While the move would require state legislative approval, Reuters reported that public health experts are worried that the decision will contribute to the declining vaccination rates around the country and put more people at risk of contracting diseases such as measles.

FDA announced it has created a Green List import alert to stop active pharmaceutical ingredients (API) used to make GLP-1 (glucagon-like peptide-1) drugs from unverified foreign sources from getting into the US. The Green List contains a list of companies who “appear to be in compliance with CGMP requirements” and are excluded from having their products detained upon import. Reuters reported the move is part of the agency’s ongoing efforts to go after drug compounders who have been making the blockbuster weight-loss and diabetes drugs to fill a drug shortage, and they are concerned that the compounded drugs pose safety risks.

Drugs & Biologics

The Center for Drug Evaluation and Research (CDER) and CBER proposed a new process under FDA's Rare Disease Evidence Principles (RDEP) to help develop rare disease treatments for unmet needs in situations with very small patient populations and known genetic defects that contribute to the disease. The process will allow reviewers to evaluate the treatments based on additional supportive data.

FDA and the Center for Research on Complex Generics (CRCG) are hosting a two-day hybrid meeting on 19 November to discuss advancements and regulatory challenges associated with developing generic ophthalmic products. More specifically, organizers state that attendees will learn about in vitro drug release testing, qualitative (Q1) and quantitative (Q2) sameness of complex ingredients in ophthalmic products, formulation characterization, considerations for clinical bioequivalence studies, and challenges with assessing prospective generic ophthalmic products.

FDA announced it has approved Sanofi's drug Wayrilz (rilzabrutinib) to treat adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to immunoglobulins, anti-D therapy, or corticosteroids. The company issued a statement noting the drug was already approved in June in the United Arab Emirates and is under review in the European Union and China.

FDA published its updated over-the-counter (OTC) Monograph Drug User Fee Program (OMUFA) arrears and paid facilities lists on its website. The agency listed almost 1,200 facilities that have not fulfilled their obligations under OMUFA.

Medtech

FDA's General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee is set to meet virtually on 8 October to discuss germicidal ultraviolet (UV) light medical devices used for disinfection. The agency said it wants stakeholders' feedback on improving the total product lifecycle (TPLC) evaluation of the products.

This Week at FDA: FDA to scrutinize co-administered vaccines, new CRLs, and a GLP-1 ‘Green List’

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