This Week at FDA: Top lawmaker retiring, FDA announces meetings, mifepristone studies retracted

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 the chair of the powerful House Energy and Commerce (E&C) committee announced she will not seek re-election, FDA announced several upcoming meetings, and two studies critical of the abortion drug mifepristone have been retracted by the publisher.

In major news this week, E&C Chair Cathy McMorris Rodgers (R-WA) announced that she is retiring, leaving one of the most powerful committee seats up for grabs after her term ends. McMorris Rodgers has been cited as one of the main obstacles to passing the Verifying Accurate, Leading-edge IVCT Development (VALID) Act in 2022, which would have created a new diagnostics pathway at FDA.

The Associated Press reports that the journal Health Services Research and Managerial Epidemiology has retracted two studies that were critical of the abortion drug mifepristone due to conflicts of interest by their authors and flaws in the study's conclusions. According to AP, the studies were cited in US District Court Judge Matthew Kacsmaryk’s ruling that could restrict access to the drug. The Supreme Court is set to consider a challenge to Kacsmaryk’s ruling in March.

On Tuesday, the Foundation for the National Institutes of Health (FNIH) published a regulatory playbook meant to accelerate the development of adeno-associated virus (AAV) gene therapies to treat rare diseases. The playbook was developed by the Accelerating Medicines Partnership (AMP) Bespoke Gene Therapy Consortium. According to FNIH, the playbook is meant to serve as a “one-stop-shop guide” for drug developers to walk them through the necessary steps prior to submitting an investigational new drug (IND) application for first-in-human studies.

This week, the Center for Drug Evaluation and Research’s (CDER) Office of Generic Drugs (OGD) provided an update on its parallel scientific advice (PSA) pilot with the European Medicines Agency. The pilot was launched in 2022 to provide makers of complex generic drugs, called “hybrid medicines” in the EU, with advice from both agencies in parallel. FDA said that two applicants have been granted PSA meetings and have completed the process so far and that it and EMA will implement changes to the program based on recommendations from the participants.

According to Pink Sheet, former FDA Commissioner Scott Gottlieb has warned that FDA would be subject to even greater control under if former President Donald Trump were reelected for a second term.

There are also several meetings scheduled by FDA next week, including a joint three-day meeting starting 13 February with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada to discuss pharmacovigilance compliance. Regulators will present on a broad range of issues, including good clinical practice, bioequivalence, and pharmacovigilance after the pandemic.

On 13 February, FDA's Circulatory System Devices Panel will meet to discuss Abbott's premarket approval application (PMA) for its TriClip G4 System. The device is intended to treat symptomatic severe tricuspid regurgitation in patients where past treatments have failed and who are at intermediate or greater risk for surgery.

The Center for Drug Evaluation and Research’s (CDER) Office of Clinical Pharmacology is holding a joint two-day public workshop with the American Association for Cancer Research (AACR) starting 15 February to discuss best practices for evaluating clinical and non-clinical data that can be to determine drug dosage. The workshop will also discuss new clinical trial designs and highlight cancer research from various stakeholders.

Drugs & Biologics

FDA announced that its Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet 5 March to recommend selecting influenza virus strains that may be used to develop vaccines for the 2024 to 2025 influenza season.

The agency will also hold a two-day workshop beginning 20 May titled, “FY 2024 Generic Drug Science and Research Initiatives Workshop.” It said the workshop will provide attendees with an overview of current generic drug research initiatives and help fulfill its Generic Drug User Fee Amendment (GDUFA III) commitment to develop an annual list of such initiatives.

FDA published a final rule codifying what sponsors of certain biological products can submit in their master files. The agency said the rule allows sponsors to include information on the drug substance, drug substance intermediate, or drug product (DS/DSI/DP) information if that information was already referenced when the application was deemed to be a license.

FDA said it had extended the comment period for its draft guidance “Advanced Manufacturing Technologies Designation Program," which was published on 13 December 2023. The agency has received numerous requests to extend the deadline so stakeholders can now comment on the guidance until 13 March.

CDER published an interview with Alexandria Smith with its Office of Communications (OCOMM) to highlight its communications testing program. She discussed the history of the program and how the agency uses it to figure out how it should package its communication depending on the target audience.

STAT News reports that membership on a key Health and Human Services (HHS) vaccine panel – the Advisory Committee on Immunization Practices – has dwindled from 15 members to just seven, with no active chairperson. According to STAT’s reporting, the Center for Disease Control and Prevention (CDC) nominated new members to the committee in 2023, but their dossiers are still under review at HHS.

Medtech

Following a public meeting last week, MedtechDive reports that FDA’s Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee has recommended new standards for pulse oximeters to make them more accurate in people with darker skin. Concerns about the accuracy of pulse oximeters emerged during the COVID-19 pandemic, which prompted a sharp increase in their use, after studies found the devices overestimated blood oxygen levels in patients with darker skin pigmentation.

FDA announced a meeting of its Ophthalmic Devices Panel on 21 March to discuss Balance Ophthalmics’ de novo application for its FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System. The device is intended to be an adjunctive treatment to reduce intraocular pressure (IOP) during use in adults with open-angle glaucoma and IOP ≤21 mmHg.

This Week at FDA: Top lawmaker retiring, FDA announces meetings, mifepristone studies retracted

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