The reckoning facing the NIH

The ideas and innovators shaping health care

May 09, 2024 View in browser   By Erin Schumaker, Ruth Reader, Carmen Paun and Daniel Payne AROUND THE AGENCIES Bill Cassidy is in line to lead the committee that oversees the National Institutes of Health if Republicans win a Senate majority. | Francis Chung/POLITICO The National Institutes of Health will face an overhaul if Republicans gain control of the Senate next year. Louisiana Sen. Bill Cassidy — the Republican in line to lead the Senate committee that oversees the agency — said Thursday that reform was long overdue. "Congress has not thoroughly reviewed NIH operations and practices since the 21st Century Cures Act passed in 2016," he said in a release. Cassidy wants NIH to: — Maintain a balanced research portfolio, so that funding does not favor late-stage research at the expense of early-stage research — Streamline the peer-review process — Address recruiting and biomedical workforce retention problems — Collaborate with public health agencies, health care systems and the private sector — Enhance transparency by tapping the NIH's Scientific Management Review Board to provide feedback on agency structure and operations. — Create a structure for the public to give NIH feedback Why it matters: With its sprawling 27 institutes and centers and a $47 billion budget, NIH is the top biomedical research funder worldwide. Once a bipartisan priority, Republicans have sought to slash the agency’s budget since the pandemic.   THE GOLD STANDARD OF HEALTHCARE POLICY REPORTING & INTELLIGENCE: POLITICO has more than 500 journalists delivering unrivaled reporting and illuminating the policy and regulatory landscape for those who need to know what’s next. Throughout the election and the legislative and regulatory pushes that will follow, POLITICO Pro is indispensable to those who need to make informed decisions fast. The Pro platform dives deeper into critical and quickly evolving sectors and industries, like healthcare, equipping policymakers and those who shape legislation and regulation with essential news and intelligence from the world’s best politics and policy journalists. Our newsroom is deeper, more experienced and better sourced than any other. Our healthcare reporting team—including Alice Miranda Ollstein, Megan Messerly and Robert King—is embedded with the market-moving legislative committees and agencies in Washington and across states, delivering unparalleled coverage of health policy and the healthcare industry. We bring subscribers inside the conversations that determine policy outcomes and the future of industries, providing insight that cannot be found anywhere else. Get the premier news and policy intelligence service, SUBSCRIBE TO POLITICO PRO TODAY.     WELCOME TO FUTURE PULSE New Harbor, Maine. | Shawn Zeller/POLITICO This is where we explore the ideas and innovators shaping health care. A court in the Philippines revoked a permit to cultivate genetically modified rice that combats vitamin A deficiency saying there was no scientific consensus the crop is safe. 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.   AROUND THE NATION Facebook scrolling may soon be a different experience for Maryland kids. | Diptendu Dutta/AFP via Getty Images Social media companies will need to revamp their sites so they don’t serve up inappropriate content to kids in Maryland under legislation that the state’s Democratic governor, Wes Moore, signed today. Firms like Facebook and TikTok will have until April 1, 2026, to assess how their platforms affect children and make changes to protect kids from content that could harm their mental health. The law also prohibits companies from collecting data about kids’ scrolling habits to fuel algorithms that could push potentially harmful content. Both the Maryland House and Senate approved the bill unanimously last month. Why it matters: Legislators and public health officials are concerned that social media is contributing to a rise in mental distress among teens. Data from the Centers for Disease Control and Prevention shows that in 2021 more than 40 percent of high school students felt so sad or hopeless at some point that they stopped regular activities. Legislation to regulate social media to protect kids has bipartisan support in Congress, but lawmakers have yet to pass a bill, leaving a void states are starting to fill. California and Connecticut have passed “age-appropriate design” laws, similar to Maryland’s, tasking tech companies with shielding kids from potentially harmful content. The tech giants oppose such legislation, arguing it violates the First Amendment. Two years ago, NetChoice, an advocacy group that counts TikTok and Facebook among its members, sued to block California from implementing its age-appropriate design law. In September, a federal district court judge in San Jose granted a preliminary injunction blocking enforcement of the law until the court can consider its constitutionality. But the Maryland bill’s sponsor, Democratic Del. C.T. Wilson, said he’s not worried. “That’s why we have an attorney general,” he said. What’s next? Similar legislation is under consideration in Vermont, Minnesota, New Mexico and Illinois.   LISTEN TO POLITICO'S ENERGY PODCAST: Check out our daily five-minute brief on the latest energy and environmental politics and policy news. Don't miss out on the must-know stories, candid insights, and analysis from POLITICO's energy team. Listen today.     WASHINGTON WATCH A drugmaker hopes to show a pyschedelic drug could benefit people with post-traumatic stress disorder. | Fernando Vergara/AP The Food and Drug Administration is nearing a decision on approving the first psychedelic drug to treat a mental illness. How’s that? The agency will hold an advisory committee meeting on June 4 to consider drugmaker Lykos Therapeutics’ application for psychedelic-assisted therapy to treat post-traumatic stress disorder. The application is for talk therapy combined with MDMA, or ecstasy. According to Lykos, it’s the first potential new treatment for PTSD in a quarter century. The FDA granted the application priority review, meaning the agency will review it over six months instead of 10. “We look forward to the opportunity to discuss the comprehensive data package of investigational MDMA and how, if approved, it may be used as a prescription treatment in combination with psychological intervention in adults with PTSD,” Lykos CEO Amy Emerson said in a statement. Why it matters: PTSD is common and difficult to treat. The Department of Veterans Affairs estimates that roughly 5 percent of Americans have PTSD in a given year. Vets are disproportionately represented. Even so: The Institute for Clinical and Economic Review, an independent, nonpartisan expert review panel, was critical of Lykos’ application in a draft report the panel released in March. While the group says the draft isn’t a final assessment of Lykos’ application, it flagged serious concerns, including safety, ethical missteps, cost and potential difficulty in widely implementing the treatment. But the institute’s review has no direct impact on the FDA’s decision. What’s next? After the advisory committee makes its recommendations to the FDA, the agency will decide whether to approve Lykos’ application. Although the FDA typically follows the advisory committee’s recommendations, it’s not obligated to do so. If the FDA approves Lykos’ application, more regulatory hurdles must be scaled. The DEA has classified MDMA as a Schedule I drug, the highest category under the Controlled Substances Act, indicating that it has a high risk for abuse and no acceptable use as a treatment. The DEA would have to reschedule MDMA before doctors could prescribe it.   Follow us on Twitter Carmen Paun @carmenpaun Daniel Payne @_daniel_payne Ruth Reader @RuthReader Erin Schumaker @erinlschumaker   Follow us

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