A draft bill and a scramble
Sen. Bill Cassidy wants to settle one question before the states settle it for everyone else: who decides which AI tools get near patients? The Louisiana Republican, the outgoing chair of the Senate health committee, has released a discussion draft called the Protecting Americans Through Intelligent, Ethical, and Transparent Artificial Intelligence in Health Care Act. Everyone will call it the PATIENT AI Act.
The timing matters. As more states look to test AI in clinical settings, the FDA and CMS are scrambling to avoid a regulatory logjam. That is the shift: testing is moving faster than the rulebook.
What would the draft do? It spells out when an AI-based tool or piece of software falls under FDA oversight, and when the Office of the National Coordinator for Health Information Technology takes over instead. It would also let the FDA review software changes on a rolling basis rather than one big update at a time. A press release describes the goal as “a more predictable and consistent framework to review and reimburse for AI-based technologies.”
FDA tweaks its inspection playbook
Inside the agency, a quieter change landed on Thursday. The drug center, CDER, and the Office of Inspections and Investigations signed off on ConOps 2.0, a new plan for coordinating inspections and compliance work on human drugs. It replaces a 2017 version and covers preapproval, postapproval, surveillance and for-cause inspections.
The notable addition is the use of Remote Regulatory Assessments and Mutual Recognition Agreement inspection reports as evaluation tools. FDA says the approach helps both offices “more effectively manage the growing complexity of the pharmaceutical manufacturing landscape.” Inspecting without always showing up in person is the kind of flexibility software-driven products will need.
Menopause patches lose their warnings
Then there is the fight over estradiol. On Friday officials said three more menopause patches would drop their black-box warnings about cardiovascular disease, breast cancer and dementia. Six other menopause treatments lost theirs in February.
No advisory committee met, and the press briefing offered few details on the science. Reshma Ramachandran, a health services researcher at Yale School of Medicine, said she was concerned “by the lack of transparency behind these decisions.” Dropping the warnings wholesale, she argued, “can be misleading for patients and underplays real potential harms.”
Officials pointed instead to supply. Sarah Ibrahim of the FDA’s drug center admitted that after the February label change, demand for estradiol patches “increased significantly, and patients in many areas found it difficult to get their usual patches at their usual pharmacy.” She added: “We know that for some patients, these past months have been frustrating.” Dorothy Fink of the National Institute of Child Health and Human Development said manufacturing of estrogen patches has doubled over the past year. Patients still report stock-outs.
Beds, pet food and other alerts
The agency also warned that electric hospital beds from Medline can pose a fire hazard. Two people died and 16 others were seriously injured. Medline, based in Northfield, Illinois, told customers to stop using the beds unless they are modified. Under certain conditions, such as jammed motors, the electrical parts can overheat and lead to smoking, melting and fire. The company is ending production of homecare and long-term care beds and accessories and leaving that market.
On October 26 the FDA issued a warning about two lots of Darwin’s Natural Selections Chicken Recipe for Cats. Both tested positive for Salmonella after two cats became ill. The Washington state raw pet food maker has a long record with the agency, including a federal lawsuit. In earlier cases, the FDA cited testing that matched the E. coli strain that sickened a hospitalized child to unopened Darwin’s dog food.
One more date to circle: the FDA has proposed changing nutrient levels in infant formula in three phases, the first update since 1998, and public comment closes on 27 February 2027.
Sources
- Food and Drug Administration
- FDA offers new details on quicker approval pathway for personalized gene therapies
- Medline electric beds pose fire hazard after 2 deaths, FDA warns
- FDA again bypasses advisers to remove black-box warnings from menopause treatments
- FDA’s latest warning about a raw pet food maker follows years of contamination findings and a federal lawsuit | dvm360
- This Week at FDA: New ConOps for drug inspections, AI policy proposal, and more
Photo: Vitaly Gariev / Unsplash (Unsplash License)
