| | | | |  | | By Ben Leonard and Chelsea Cirruzzo | | | | | 
Regulating AI use in health care could prove to be a herculean task for the FDA without additional resources. | Manuel Balce Ceneta/AP | GAPS IN AUTHORITY — President Joe Biden has promised a coordinated — and fast — response from his agencies to ensure artificial intelligence safety and efficacy. But regulators like the FDA don’t have the resources they need to preside over technology that, by definition, is constantly changing, POLITICO’s Ruth Reader reports. And that lack of resources is a major reason the government hasn’t yet regulated the advanced AI that’s remaking health care. What’s the hang-up? AI advancements have created significant FDA regulatory gaps. Though the agency treats first-gen AI tools as it does other medical devices, it doesn’t review products like chatbots and has no authority over systems that summarize doctors’ notes and perform other critical administrative tasks. FDA Commissioner Robert Califf says he needs to double his staff to properly monitor technology that learns and evolves and can have varying levels of effectiveness in different venues. What the FDA wants: A new report from the Government Accountability Office, the watchdog arm of Congress, said the agency wants more power to request AI performance data and set guardrails for algorithms in more specific ways than its traditional risk assessment framework for drugs and medical devices allows. Considering Congress has barely begun to discuss, much less reach a consensus on AI regulation, that could take a while. As a result: Califf and some in industry have proposed another idea: creating public-private assurance labs, likely at major universities or academic health centers, which could validate and monitor artificial intelligence in health care. The idea has some support in Congress. Sen. John Hickenlooper (D-Colo.) has called for qualified third parties to audit advanced AI. He’s thinking specifically about generative AI like ChatGPT, which mimics human intelligence, though it’s the same oversight framework Califf has suggested. But that approach could have flaws, as some AI experts have noted, since AI tested on a university campus might not work as well at a small rural hospital. “You know as a practicing physician that different environments are different,” Dr. Mark Sendak, population health and data science lead at Duke University’s Institute for Health Innovation, told senators at a Finance Committee hearing this month. WELCOME TO TUESDAY PULSE. We hope you enjoyed the long weekend — and happy National Boston Terrier Day yesterday to all who celebrate, including your host. Send your tips, scoops and feedback to bleonard@politico.com and ccirruzzo@politico.com and follow along @_BenLeonard_ and @ChelseaCirruzzo.
| | |  Mary Poehler signs a petition in support of a ballot initiative to end Missouri's near-total ban on abortion. | Ed Zurga/AP | FUNDING FIGHT — Abortion rights could be on the ballot in as many as 12 states this November — and there might not be enough cash to go around, POLITICO's Megan Messerly and Alice Miranda Ollstein report. Already, campaigns in states such as Arizona, Missouri, Nevada and South Dakota are vying for a limited pool of funds from national organizations trying to determine where they can get the most bang for their buck. Why it matters: The campaigns on the short end of those decisions could find themselves starved of the cash needed to gather petition signatures, beat back attempts from GOP officials to block the measures and persuade voters to restore access to millions of people. “No one’s coming to save us,” said Gennie Diaz, executive director of the group For AR People, which is leading Arkansas’ ballot measure campaign. “We don’t begrudge any group for having a nuanced strategic plan that we don’t necessarily fit into. … But if we do not receive the funding to run a robust statewide campaign, the consequence will be that women will die in this state. We need that funding so we can restore access and prevent that from happening.”
| | | | CONGRESS OVERDRIVE: Since day one, POLITICO has been laser-focused on Capitol Hill, serving up the juiciest Congress coverage. Now, we’re upping our game to ensure you’re up to speed and in the know on every tasty morsel and newsy nugget from inside the Capitol Dome, around the clock. Wake up, read Playbook AM, get up to speed at midday with our Playbook PM halftime report, and fuel your nightly conversations with Inside Congress in the evening. Plus, never miss a beat with buzzy, real-time updates throughout the day via our Inside Congress Live feature. Learn more and subscribe here. | | | | | | | | |  Several former and current ONDCP officials have expressed concern over the leadership of the agency's director, Dr. Rahul Gupta (left), who is an ally of Sen. Joe Manchin. | Brendan Smialowski/AFP via Getty Images | ‘PRIMA DONNA’ RUNNING THE SHOW? The White House Office of National Drug Control Policy has been plagued by significant turnover and dissatisfaction with its director, Dr. Rahul Gupta, according to nine people familiar, POLITICO’s Myah Ward and Lauren Egan report. Seven former and current officials and two other people with knowledge of the office dynamics, and granted anonymity to speak candidly, called ONDCP a “toxic” work environment. Gupta — who they described as egocentric and a “prima donna” preoccupied with his public profile — is to blame, they said. At least eight top officials have resigned in recent months in large part because of Gupta’s leadership, according to the officials. The dysfunction has taken attention away from confronting the historic overdose crisis, officials said. The current and former officials told POLITICO that he’s put unrealistic pressure on his team to raise his profile. He has expected Cabinet-level treatment when traveling and would blow up plans when staff couldn’t deliver. He canceled one trip last year because he didn’t want to fly Southwest Airlines, the officials said. Formerly West Virginia’s health commissioner, Gupta is an ally of Sen. Joe Manchin (D-W.Va.), who has been a key swing vote for Democrats. What the White House has to say: An ONDCP official, in response to a request for comment, said the office’s “critical mission to address the overdose epidemic is deeply personal to Dr. Gupta: from his decades of work as a physician treating patients with substance use disorder, to leading the public health response efforts in ground zero of the opioid crisis in West Virginia.” The official added that he’s “laser-focused on the office’s work to strengthen life-saving public health services.” Manchin’s office did not respond to a POLITICO request for comment.
| | WENSTRUP SLAMS HHS OVER COMPLIANCE — Rep. Brad Wenstrup (R-Ohio), chair of the House subcommittee investigating the coronavirus, is threatening to subpoena HHS officials to compel them to cooperate with the panel as part of its investigation into the pandemic. The move comes after a hearing late last month in which Wenstrup said a top HHS official, Melanie Egorin, failed to “answer simple questions” about how the agency was complying with the investigation. Wenstrup asked for HHS to respond to a litany of questions by March 1 in a letter Friday. HHS has turned over thousands of pages of documents and offered close to 100 hours of interviews and testimony to the Select Subcommittee on the Coronavirus Pandemic, but Wenstrup said the agency has engaged in an “ongoing and deliberate effort to stonewall” his investigations. HHS’ take: The agency says it’s been “exceptionally responsive” to the subcommittee’s “wide-ranging” requests about Covid-19’s origins, a spokesperson said. “We also agree that valuable, bipartisan work remains to be done to determine the origins of the pandemic,” the HHS spokesperson said. “Unfortunately, the politicization of the oversight process doesn’t get us anywhere closer to determining the origins of the pandemic.”
| | A CELL THERAPY FIRST — The FDA has granted accelerated approval to the first cell therapy used for solid tumors, POLITICO’s Lauren Gardner reports. Iovance Biotherapeutics’ Amtagvi was approved to treat advanced melanoma that can’t be removed or has spread throughout the body and has previously been treated with other treatments. Amtagvi, approved Friday, uses T cells extracted from a patient’s tumor tissue that are then used to create healthy T cells, which are infused back into the patient. While melanomas represent a small fraction of skin cancers, the FDA said they cause a significant number of cancer-related deaths. Looking forward: The company has to finish a confirmatory trial to ensure Amtagvi has a clinical benefit for people with cancer. That work is ongoing, the FDA said.
| | Jaylen Black has joined Planned Parenthood Southeast as vice president of marketing and communications. She was previously communications manager at The Kennedy Forum and has worked for the campaigns of former Georgia gubernatorial candidate Stacey Abrams and Sen. Raphael Warnock (D-Ga.).
| | POLITICO’s Ben Schreckinger reports on Biden’s brother using the family name to promote a hospital chain that collapsed. A Johns Hopkins professor pushes back against CMS' data access decision in Forbes. POLITICO’s Adam Cancryn and Alice Miranda Ollstein report that Trump won’t rule out a 16-week abortion ban but won’t commit either. Bloomberg reports on trainee doctors in South Korea protesting a plan to increase medical school spots.
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