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Regulatory Focus – This Week at FDA: User fee moves, COVID vaccine updates, and more

Regulatory Focus – This Week at FDA: User fee moves, COVID vaccine updates, 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. There was a lot going on this week on the COVID-19 vaccines front. We made it through the first of several Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings this month on COVID-19 vaccines and have two days of meetings to look forward to next week. We also learned that the Senate health committee will markup its version of the user fee reauthorization bill next week after hitting a snag this week.

On Tuesday, VRBPAC voted unanimously, with one abstention, to recommend authorizing Novavax’s protein-based COVID-19 vaccine. Novavax is seeking emergency use authorization for the two-dose primary series for adults 18 and older.

On Wednesday, we also heard that Moderna’s Omicron-containing bivalent COVID-19 booster shot was superior to the company’s currently approved vaccine in a Phase 2/3 trial. More on that from STAT.

Next week, the VRBPAC committee will meet for two days to discuss expanding the use of the Moderna and Pfizer-BioNTech vaccines to younger children. The committee will meet on 14 June to discuss expanding the use of Moderna’s vaccine to children 6 to 17 years of age. On 15 June, the committee will shift its focus to expanding the use of both vaccines to infants and younger children for the first time.

On the Hill

Earlier this week, the House voted 392-28 to approve legislation to reauthorize FDA’s user fee programs before they expire at the end of September. Now, attention turns to the Senate Health, Education, Labor and Pensions (HELP) committee, where the Senate bill will be marked up next week after a slight delay.

Next Wednesday, the House Appropriations subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies will meet to markup legislation for FY2023 appropriations.

The HELP committee will also meet next Thursday to review the ongoing Federal response to COVID-19. FDA Commissioner Robert Califf is set to testify at the hearing, and will be joined by CDC Director Rochelle Walensky, NIAID Director Anthony Fauci and Dawn O’Connell, assistant secretary for preparedness and response at HHS.

Drugs & biologics

FDA’s Center for Biologics Evaluation and Research (CBER) sent a letter to sponsors, applicants and other regulated entities advising them that the center plans to “resume normal operations” as it enters calendar year 2023. The letter notes that CBER intends to continue prioritizing COVID-19-related activities for the remainder of the calendar year, though it will continue holding “all external meetings in virtual format.”

“CBER will continue to assess the feasibility of holding in-person meetings at FDA facilities. Sponsors and applicants should monitor the CBER website for updates regarding in-person meetings,” CBER said. The letter also provides updates on the center’s policies on incoming documents, noting that paper and electronic media submissions are now welcomed via US mail or courier effective immediately.

We also learned from CBER this week that Emergent Travel Health has resolved a shortage of its typhoid vaccine Vivotif after it temporarily discontinued manufacturing and distribution of the oral vaccine due to the “significant reduction of international travel caused by the COVID-19 pandemic.

Plus, we learned that FDA’s draft guidance on Considerations for Rescinding Breakthrough Therapy Designation has reached the White House Office of Management and Budget for review.

FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) voted unanimously in favor (15-0) of approving Bluebird Bio’s eli-cel gene therapy for cerebral adrenoleukodystrophy (CALD) for children under the age of 18. The committee also voted unanimously in support of approving the company’s beti-cel gene therapy for beta-thalassemia.

The Office of Generic Drugs (OGD) has issued a new manual of policies and procedures (MAPP) detailing how it assesses the user interface of a drug-device combination product submitted as part of an abbreviated new drug application (ANDA) or pre-ANDA communication.

Medical devices

FDA has identified several recalls as Class I recalls within the last week. The recalls include Medtronic’s HVAD Pump Implant Kit, Woodside Acquisitions’ Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits,

The agency classified intravascular bleed monitors into class II (special controls) earlier this week.

We also saw a statement from the Friends of Cancer Research voicing support for the Verifying Accurate Leading-edge IVCT Development (VALID) Act contained within the Senate user fee reauthorization bill. “We believe that now is the time to establish a framework to sufficiently evaluate the performance of diagnostic tests and ensure their accuracy while providing appropriate flexibility to enable continued innovation,” the group wrote.