Article Summary:
The FDA has faced criticism over several recent expert panel meetings, which do not require the same level of scrutiny as traditional advisory committees. Concerns have been raised that the panelists were hand-picked by the FDA Commissioner and did not have to provide public briefing documents or give adequate notice for public engagement. For example, an expert panel on the effects of antidepressants during pregnancy was dominated by members who are skeptical of the drugs, some of whom profit from that skepticism. Another panel on oral fluoride supplements included Health and Human Services Secretary Robert Kennedy Jr., who has advocated for removing fluoride from water.
Senators have reintroduced a bill to increase transparency of federal advisory committees by codifying the collection and public release of information about them. Meanwhile, the FDA Commissioner and CDC Director have written that they prefer to negotiate with industry to persuade them to adopt policies voluntarily rather than force those policies through rulemaking. The Commissioner has also reinstated about a quarter of the staff who were fired under the Trump administration.
The FDA’s new Elsa artificial intelligence assistant has been found to have limitations, unable to access relevant documents or fully answer basic questions. The acting director of the FDA’s Digital Health Center of Excellence is also leaving the agency. Separately, the FDA, HHS, and USDA are seeking public input on how to define ultra-processed foods.
In drug and medical device news, the FDA has extended the review period for a non-hormonal menopause drug, while Sarepta Therapeutics will need to conduct a new study for its Duchenne muscular dystrophy drug. The agency has also recalled certain ventilator systems and surgical staplers due to safety concerns.