This Week at FDA: Prasad’s second exit from FDA, ACIP backs off COVID-19 vaccine, 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, FDA announced the head of its biologics center is leaving the agency for the second time, the CDC’s vaccine panel may be abandoning a plan to stop recommending COVID-19 mRNA vaccines, and a senator plans to investigate FDA’s oversight of rare disease therapies.

The biggest news this week is that Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER), is leaving the agency for a second time at the end of April. News outlets have reported that he has faced a slew of controversies, including overruling his reviewers to deny or delay several products, including Moderna's mRNA influenza vaccine and UniQure’s Huntington's disease treatment, as well as allegations of abusive treatment toward subordinates.

The Wall Street Journal editorial board has been especially critical of Prasad over the past year, accusing him of undermining President Trump's stated goal of accelerating treatments to market while reducing healthcare costs. The board also criticized FDA Commissioner Marty Makary for continuing to defend Prasad.

As Prasad gets ready to leave FDA, the agency is also looking to hire a CBER deputy director, according to USAjobs.gov. Interested candidates have until 25 March to apply.

Bloomberg News reported that Sen. Ron Johnson (R-WI) wants to investigate FDA's recent decisions to deny approval of certain rare disease drugs. It's worth noting that he is an ally and strong supporter of President Donald Trump, Health and Human Services Secretary Robert Kennedy Jr., and the Make America Healthy Again (MAHA) movement.

GlaxoSmithKline's Wellcovorin (leucovorin calcium) received expanded-use approval to treat cerebral folate deficiency in patients with a confirmed variant in the folate receptor 1 gene (CFD-FOLR1). The agency reached out to GSK in September to approve the drug, and at the time, Makary said it wanted to approve the drug as a treatment for children with autism. The move faced significant criticism, with experts worried that it could undermine the agency's regulatory standards.

Interestingly, the drug was not approved for the treatment of autism, though in a press release, Makary said, it could "benefit some individuals with FOLR1- related cerebral folate transport deficiency who have developmental delays with autistic features.”

The Washington Post reported that, according to anonymous sources, members of the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) are backing down on a plan to stop recommending COVID-19 mRNA vaccines. The advisory panel is slated to meet for two days starting on 18 March.

Drugs & Biologics

FDA has issued warnings to several companies in recent months for marketing unapproved cell and gene therapy products. This week, the agency also issued a direct warning to consumers not to use such unapproved products and noted that recently a patient died after using Laennec, a suspected imported human placental tissue-derived product that the agency has not approved and is investigating.

FDA reminded stakeholders to register for a three-day joint hybrid symposium with the UK's Medicines and Healthcare Products Regulatory Agency and Health Canada on Good Clinical Practice (GCP), Bioequivalence (BE), and Good Pharmacovigilance Practice (GVP). While the event has run out of in-person spots, organizers note that people can sign up to participate virtually.

FDA is hosting a webinar on 5 May to provide an overview of the Over-the-Counter Drug User Fee Amendments (OMUFA) and discuss how key elements relate to OMUFA user fees. More specifically, the agency will provide details on the different user fee types, drug facility registration process, fee payment process, and answer frequently asked questions.

Medtech

The latest Medical Device User Fee Amendments (MDUFA VI) meeting minutes from 18 February between FDA and the medtech industry were posted this week. Among the issues raised during the meeting, the industry asked the agency about enrollment criteria for the total product lifecycle advisory program (TAP) and whether regulators would be open to additional metrics for the program. Also worth noting, FDA confirmed it would integrate a pre-submission fee into the overall fee structure model.

FDA has issued an early alert for certain lots of Erbe USA's Flexible Cryoprobes used to destroy tissue, including tumors. The agency said it has received reports that the probes can rupture, causing hearing damage and burns.

Following the recent adoption of the new Quality Management System Regulation (QMSR), FDA said it is hosting a virtual town hall to discuss the updated Inspection of Medical Device Manufacturers Compliance Program (CP) Manual (CP 7382.850), which went into effect on 2 February. The manual includes a new inspection process that meets the new QMSR requirements.

FDA said that after receiving more than 8,100 comments on a rule that restricted the use of sunlamp products to adults, those who have signed a waiver, and updates to user manuals, the agency has decided to withdraw it. The agency said it made the decision after commentators raised scientific and technical concerns, as well as concerns about unintended consequences.

This Week at FDA: Prasad’s second exit from FDA, ACIP backs off COVID-19 vaccine, more

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