This Week at FDA: Expert panels draw criticism, HHS seeks to define ultra-processed foods

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 faced criticism over several recent expert panel meetings, top US health officials said they want to cooperate with industry rather than forcing it to change, and FDA and the Department of Agriculture (USDA) are looking for input on how to define ultra-processed foods.

Several news outlets have reported on the FDA’s recent spate of expert panel meetings, which, unlike traditional advisory committees, do not require the same level of scrutiny when selecting members. Medpage Today noted that the agency has hosted four recent expert panels that have raised concerns because, according to some experts, the panelists were hand-picked by FDA Commissioner Marty Makary. They also said that the expert panels did not have to provide briefing documents for public scrutiny or give the same level of notice for public engagement.

STAT News reported that during an expert panel meeting to discuss the effects of selective serotonin reuptake inhibitor (SSRI) antidepressants used during pregnancy, invited panel members who have a history of being skeptical of antidepressants, some of whom profit from that skepticism, focused on the risks of the drugs. Most of the members expressed concerns that haven't been scientifically proven that antidepressants are harmful to babies. STAT noted that the panel “looked a lot like a group of like-minded friends,” rather than a panel with representation from opposite sides of an issue.

STAT also reported that the FDA convened an expert panel on 23 July to discuss the potential risks of oral fluoride supplements, which are sometimes used to treat children with dental health issues in places without fluoridated water. Health and Human Services (HHS) Secretary Robert Kennedy Jr. has advocated removing fluoride from water, such as during his confirmation hearing, and argues that it lowers intelligence.

Senators Gary Peters (D-MI), ranking member of the Homeland Security and Governmental Affairs Committee, and Bill Cassidy (R-LA), chair of the Health, Education, Labor, and Pensions (HELP) Committee, have reintroduced a bill that they say will increase transparency of federal advisory committees. The bill is intended to codify the General Services Administration's (GSA) collection of advisory committee information and publicly publish the information online.

Makary and Mehmet Oz, director of the Center for Disease Control and Prevention (CDC) wrote an op-ed in the Wall Street Journal that their decision to negotiate with regulated industries to persuade them to adopt policies voluntarily rather than force those policies on them has been fruitful. They argued that using traditional rulemaking actions would have taken much longer to achieve the same effect.

In a preview of an interview with Politico's Dasha Burns, Makary said he has reinstated about a quarter of the staff at FDA who were fired as part of the Trump administration's reduction-in-force (RIF) efforts. He also said that he has no plans to fire any more staff and is confident the agency will be able to continue its work unhindered.

CNN reported that, according to current and former FDA officials, the agency's new Elsa artificial intelligence assistant can be used for tasks such as generating meeting notes and assisting with emails, but it's incapable of helping with review work because it can't access relevant documents, such as premarket submissions, and answer basic questions. Despite assurances recently from the agency, the AI tool has reportedly been found to hallucinate or misrepresent research in certain situations.

Politico also reported that Sonja Fulmer, acting director of the FDA’s Digital Health Center of Excellence (DHCoE) at the Center for Devices and Radiological Health (CDRH), is leaving the agency. Fulmer, has been with CDRH for more than a decade and stepped into the acting director role after Troy Tazbaz stepped down as DHCoE director in January.

FDA, HHS, and USDA issued a request for information (RFI) to get public feedback on how the federal government should define ultra-processed foods. The departments said a uniform definition would allow for more consistent research and policy development on the topic.

Drugs & Biologics

HHS is offering a grant to research ways to improve regulatory science in detecting and monitoring cardiotoxicity of oncology drugs. Interested parties can apply for the grant through 8 August.

Reuters reported that FDA has extended the review period for Bayer's non-hormonal menopause relief drug elinzanetant, which is marketed in the UK under the brand name Lynkuet. The agency extended the review period by 90 days but did not raise any concerns about the drug's approvability.

Endpoints News reported that Sarepta Therapeutics will need to conduct a new study for its Duchenne muscular dystrophy drug Elevidys (delandistrogene moxeparvovec-rokl) in order to prove its safety. The news comes after the company paused distributing the drugs after three patients who had received the drug died, according to Fierce.

Medtech

Maquet Critical Care, a subsidiary of Getinge, has issued a class I recall for its Servo Ventilator Systems due to concerns that inaccurate compliance measurements can output the wrong tidal volume delivery for neonatal patients, which could cause them not to receive enough oxygen or too much carbon dioxide. The company has provided updated instructions to address the problem.

FDA has rescheduled a meeting of its General and Plastic Surgery Devices Panel for 13 August to discuss new indications for dermal filler devices in the décolletage area. The meeting had originally been planned for 20 February but was postponed after the Trump administration halted agency meetings.

Ethicon Endo-Surgery has issued a class I recall for some of its Endopath Echelon disposable surgical staplers that are at risk of locking out during surgical procedures, which may lead to them not cutting or stapling tissue. The agency said its representatives will be contacting customers to familiarize them with the instructions for use.

This Week at FDA: Expert panels draw criticism, HHS seeks to define ultra-processed foods

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