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The ideas and innovators shaping health care | | | | |  | | By Kelly Hooper, Erin Schumaker, Daniel Payne and Ruth Reader | | | | | 
Sen. Joe Manchin (D-W.Va.) said the FDA bears some of the blame for the addiction crisis that ensued after the agency approved opioid painkillers. | Rod Lamkey for POLITICO | Sen. Joe Manchin (D-W.Va.) took aim at President Joe Biden’s handling of the fentanyl crisis at POLITICO’s Health Care Summit today in Washington. On fentanyl, the synthetic opioid that drove a 60 percent increase in fatal drug overdoses during the Covid pandemic and continues to cause most of the record 110,000 drug overdoses annually, Manchin said the Food and Drug Administration is partly to blame. “The FDA started it. They keep bringing more products,” Manchin said of the agency that approved the prescription opioids that started the opioid addiction crisis. Manchin also criticized the FDA for failing to remove from the market older opioid drugs from the market when newer, safer ones come online. The FDA has historically approved opioids like they do any other drug — by evaluating safety and efficacy of the proposed medication. But lawmakers and others have pushed them to more expansively consider public health concerns, and FDA Commissioner Robert Califf has suggested his agency needs greater authority from Congress. In a panel discussion directly after Manchin’s at the POLITICO Health Care Summit, FDA Principal Deputy Commissioner Namandjé Bumpus defended her agency. “We make science-based decisions,” said Bumpus. “We leverage our science and decisionmaking to make the best decisions we can.”
| | | | JOIN US ON 3/21 FOR A TALK ON FINANCIAL LITERACY: Americans from all communities should be able to save, build wealth, and escape generational poverty, but doing so requires financial literacy. How can government and industry ensure access to digital financial tools to help all Americans achieve this? Join POLITICO on March 21 as we explore how Congress, regulators, financial institutions and nonprofits are working to improve financial literacy education for all. REGISTER HERE. | | | | | | | | | 
POLITICO's Eugene Daniels interviews President Joe Biden's domestic policy adviser, Neera Tanden, at POLITICO's 2024 Health Care Summit | Rod Lamkey | This is where we explore the ideas and innovators shaping health care. White House Domestic Policy Adviser Neera Tanden promised that President Joe Biden would seek to legalize abortion nationwide if he gets a second term and a Democratic majority in Congress. Share any thoughts, news, tips and feedback with Carmen Paun at cpaun@politico.com, Daniel Payne at dpayne@politico.com, Ruth Reader at rreader@politico.com or Erin Schumaker at eschumaker@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp.
| | |  The Mission Within psychedelic medicine clinic Rep. Lou Correa (D-Calif.) visited on a fact-finding mission last month. | Courtesy of the Mission Within | Congress wants the Veterans Affairs Department to lead the way in psychedelics research. Included in the government funding law President Joe Biden signed on Saturday is an amendment directing the VA to spend $20 million on large-scale trials of emerging therapies, including talk therapy combined with MDMA, also known as ecstasy, and psilocybin, the psychedelic compound in magic mushrooms. The drugs can cause hallucinations and change users’ perceptions of reality. Long considered party drugs, researchers are examining their utility in treating mental illness. The backstory: The provision, authored by Reps. Lou Correa (D-Calif.) and Jack Bergman (R-Mich.), encourages the VA to use federal funding to study psychedelics as mental health treatments for veterans. The Food and Drug Administration has designated MDMA and psilocybin as breakthrough therapies, a label meant to speed their development. The news comes on the heels of the defense bill Congress passed late last year, which includes an amendment authorizing the Pentagon to study psychedelic treatments for service members. Correa traveled to Mexico last month to visit a clinic that provides psychedelic treatment to U.S. veterans to see how it works and whether it should be offered in America. Why it matters: Investing federal funding in psychedelics research is yet another indication that Congress is warming up to psychedelics as a potential treatment for mental health conditions like post-traumatic stress disorder, which disproportionately affects veterans, particularly those who have deployed to war zones. Both male and female veterans with PTSD are at a higher risk for suicide than veterans without the condition. About 5 percent of Americans have PTSD in any given year, according to the VA. What's next? Juliana Mercer, a Marine Corps veteran and director of veteran advocacy and public policy at the advocacy group Healing Breakthrough, called Congress’ decision “a significant first step towards meaningfully reducing the veteran suicide rate.” The group’s next focus is ensuring the VA has the resources to scale MDMA-assisted therapy, she told Erin in a statement. Zoom out: In February, the FDA accepted Lykos Therapeutics’ new drug application for talk therapy combined with MDMA and granted it priority review. That means the agency will review the application over six months, with a target date of Aug. 11 to decide whether to approve it.
| | | | DON’T MISS AN IMPORTANT TALK ON ACCESS TO AFFORDABLE PRESCRIPTION DRUGS IN CA: Join POLITICO on March 19 to dive into the challenges of affordable prescription drugs accessibility across the state. While Washington continues to debate legislative action, POLITICO will explore the challenges unique to California, along with the potential pitfalls and solutions the CA Legislature must examine to address prescription drug affordability for its constituents. REGISTER HERE. | | | | | | | | |  Doctors say they're interested in tools that ease their administrative burdens. | AFP via Getty Images | Salesforce, the customer-relations software giant whose products are used across sectors, is bringing its artificial intelligence to health care. The new offering focuses on performing administrative tasks and summarizing patient information — from drugs to diagnoses, social factors to care gaps. Care providers and managers can use the software to better understand a patient’s situation and connect them to care. The software, Einstein Copilot: Health Actions, is built with the company’s Einstein 1 Platform, which uses AI to scour datasets. The company said it has health customers, including Baptist Health South Florida and HarmonyCares, a home health service, using its software. Why it matters: Salesforce is the latest company to present its vision for AI in health care. The market has become crowded, with tech companies and health organizations — established names and startups — creating AI solutions for providers and insurers. Despite health leaders’ high hopes for the tech, policymakers are concerned about safety, privacy and the use of untested systems. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
