This Week at FDA: Califf faces Senate Appropriations hearing, interagency biotech plan, and remanufacturing guidance

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 Commissioner Robert Califf testified on the agency’s response to the ongoing outbreak of highly pathogenic avian influenza in dairy cattle, among other issues facing the agency, at a Senate Appropriations subcommittee hearing on Wednesday.

Califf said the country should prepare for the possibility that the virus “may jump to humans” but assured the committee that the situation is under control. He described how FDA is involved in a multi-agency effort to coordinate a response; other agencies involved include the Department of Agriculture, the Centers for Disease Control and Prevention, and the White House Office of Pandemic Preparedness and Response Policy. He told the panel that FDA is meeting daily with other agencies to review and monitoring recent developments and formulating a response.

Also this week, Environmental Protection Agency (EPA), FDA and the Department of Agriculture (USDA) announced a plan to update, streamline, and clarify their regulations and oversight for biotechnology products. The plans fulfill President Biden’s Executive Order 14081 on advancing the nation’s biotechnology industry. In the plan, FDA announced plans to revise regulations related to post-approval chemistry, manufacturing, and controls (CMC) changes for both drugs and biological products and to “provide greater clarity on its oversight of post-approval CMC changes for certain biotechnology products.”

In other major news, FDA issued its long-awaited final guidance on remanufacturing medical devices; a draft guidance was published in 2021. The guidance aims to clarify the distinction between device "servicing" and "remanufacturing" and revisions based on comments to the draft guidance, including clarification on activities that constitute a remanufacturing of a device, applicability to OEMs and external entities contracted by OEMs. Remanufacturing has greater regulatory implications for manufacturers while servicing is viewed by FDA as not changing the safety or performance specifications of a device. (RELATED: FDA issues long-awaited device remanufacturing guidance, Regulatory Focus 10 May 2024).

FDA also announced it will be holding a webinar on 27 June to discuss the device remanufacturing guidance.

Drugs & Biologics

On Friday, Fierce Pharma reported that FDA delayed a decision on Moderna’a RSV vaccine until late May, citing the delay to “administrative constraints” but is expected to approve the product.

Also on Friday, Reuters reported the Biden administration is expected levy new tariffs on Chinese-made medical devices like syringes and personal protective equipment under a new trade strategy expected to be announced next week.

FDA also responded to a citizen petition from HBT Labs requesting FDA assign a therapeutic equivalence evaluation code (TE code) for its Paclitaxel injectable suspension used in chemotherapy treatment. The company asserted that the product is pharmaceutically equivalent to Abraxane and have “identical amounts (100 mg/vial) of the identical active drug ingredient and are in identical dosage forms.” FDA partially granted this request, stating that “while the Petition requests that FDA assign an ‘AP’ TE Code … an ‘AB’ and not an ‘AP’ TE code would be appropriate here.”

On Thursday, Endpoints reported that an advisory committee has delayed its decision on whether Duchenne muscular dystrophy should be included in a federally-recommended newborn screening panel.

On 4 June, FDA will hold a meeting of its Psychopharmacologic Drugs Advisory Committee to discuss an NDA for midomafetamine capsules in combination with psychological intervention for treating PTSD.

FDA’s Oncology Center of Excellence (OCE) has announced its new crowdsourcing initiative called “Project 5 in 5” to solicit ideas from the public on five “clinically relevant” questions that can be answered through use of “pragmatic clinical trials” over the next five years. FDA said ideas from the pilot will be shared with other agencies and groups. The agency defines pragmatic clinical trials as incorporating design elements that are more reflective of routine clinical practice.”

On Friday, STAT reported that efforts to cure HIV through the use of CRISPR genome editing tools failed in an early clinical trial; the study was run by Excision BioTherapeutics.

FDA has announced a postponement of its Vaccines and Related Biological Products Advisory Committee from 16 May to 5 June and the committee is expected to recommend strains for the 2024-2025 formula for COVID-19 vaccines.

FDA’s CBER has issued an untitled letter to Exocel for making claims that its exosome products for injection or topical use can diagnose or cure a disease without seeking approval.

FDAs Office of Study Integrity and Surveillance (OSIS) has announced a workshop on CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice on 13 June.

FDA has announced a workshop on 16 May of its OTC Monograph Drug User Fee Program (OMUFA) user fee program to enhance public understanding of FY 2023 user fees.

Medtech

On Wednesday, FDA announced a recall of Sol-Millennium Medical Inc.’s products that contain unauthorized plastic syringes made in China. The agency said this includes syringes with needle and syringe components packaged together, low dead space (LDS) syringes, luer slip tip syringes, eccentric tip syringes, and syringe accessories. The recall is the latest in a string of actions related to plastic syringes made in China.

FDA has issued a safety communication alerting health care providers and facilities on continued safety and quality concerns with two Getinge/Maquet’s cardiovascular medical devices, its Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and its Cardiohelp system and HLS Sets. The FDA recommends that health care facilities transition away from these devices and seek alternatives.

FDA has announced a recall of Tandem Diabetes Care’s Version 2.7 of the Apple iOS t:connect mobile app used in conjunction with t:slim X2 insulin pump which was prompted by a software problem leading to depletion of the pump battery.

A citizen petition was submitted to FDA by Dr. David Behar requesting that CPAP machines be made available to patients without a prescription.

This Week at FDA: Califf faces Senate Appropriations hearing, interagency biotech plan, and remanufacturing guidance

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