CALIFF: AI SHOULD HELP PATIENTS — Former FDA Commissioner Robert Califf repeatedly pressed Congress to empower the agency to regulate AI in health care. Now out of government, he spoke with POLITICO’s Ruth Reader after this week’s Cornell HealthNext AI Summit about the industry’s responsibility to ensure the technology is safely used on patients. Some highlights: FDA should oversee AI standards: “The implementation of the standards should be done by mostly health systems, but they have to change the way they're doing things for it to work. They have to actually create systems that follow patients over time completely, because you can't validate the operating characteristics of algorithms unless you have follow up, just like you're doing a study pre-market.” Data should be interoperable: “If you go to Cornell for one thing and NYU for another, on a patient-by-patient basis, now, because of 21st Century Cures legislation, your doctor can get your individual record. What needs to happen is all those records need to be compiled. So let's say there's an algorithm applied at NYU and you die at Cornell hospital. There's no way to know that the algorithm did the wrong thing. But it's not a technological issue.” Concerns about AI in medicine: The biggest use of AI medicine, that is to figure out what's profitable and what's not, … that's not directly related to what is best for human beings. The system has become increasingly financialized. The clinicians and the patients, in many ways, are financial objects that are being manipulated based on an assessment of where the money gets made.” Thoughts on Makary: “I don’t know him at all. I sent him an email, he replied: I'll talk when the time is right. He hasn’t in the past said very nice things about the FDA. But it's different when you're in the seat. It is different, as I like to say, when you get that first salmonella outbreak in lettuce — you really come to appreciate the people that know what they're doing.” CUTTING ROOM FLOOR — Back to Makary, there were some notable exchanges on high drug prices during his confirmation hearing that didn’t make our immediate coverage. The FDA can’t directly regulate drug prices, but its approval of generic drugs and biosimilar products can bolster marketplace competition that should push down costs. Makary said he’s “a big believer” in approving biosimilars more quickly while maintaining scientific rigor. He also suggested more generics should be available over the counter to boost price transparency, mentioning EpiPens and naloxone as examples (while over-the-counter opioid reversal drugs are available, some are still prescription-only). “If they can be over the counter, and we can feel confident about public safety with those products on the shelf at a pharmacy, it would force the companies to put a price on the shelf,” Makary said. He also told Sen. Maggie Hassan (D-N.H.) that he’d like to work with lawmakers to address patent thickets — overlapping patents that make market entry more difficult for generics and biosimilars.
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