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KHN’s ‘What the Health?’: FDA Takes Center Stage

KHN’s ‘What the Health?’: FDA Takes Center Stage

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The FDA is still lacking a Senate-confirmed leader, but the agency is at the center of several major policy battles. Lawmakers this year must renew the bill that authorizes drug companies to pay “user fees,” which enable the agency to hire additional reviewers to speed the approval of drugs. The FDA is also increasingly involved in the abortion debate and the effort to treat the millions of Americans with Alzheimer’s disease.

Meanwhile, states led by Democrats are starting to relax some covid restrictions, even as officials at the Centers for Disease Control and Prevention complain it’s too soon.

This week’s panelists are Julie Rovner of KHN, Anna Edney of Bloomberg News, Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico, and Sarah Karlin-Smith of the Pink Sheet.

Among the takeaways from this week’s episode:

  • Congress is beginning the process of renewing the 30-year-old Prescription Drug User Fee Act (PDUFA). Although drugmakers initially were hesitant about the PDUFA program, they now support it because it has considerably cut the time for FDA approval.
  • Some experts argue, however, that the extra money generated by the PDUFA program should also be used to evaluate how drugs are working after they’re approved and in general use.
  • Key House Republican lawmakers sent a letter this week to the Department of Health and Human Services criticizing Medicare’s decision to limit the use of Aduhelm, a controversial drug for Alzheimer’s disease that won conditional approval from the FDA last fall. Medicare has agreed to cover the $28,000-a-year price tag only for beneficiaries in a clinical trial that studies the drug’s effects. The Republicans argued it would be unfair for Medicare to limit Aduhelm’s use.
  • Recent moves by state leaders to end mask mandates and other covid prevention measures come as much of the public continues to grow weary of the pandemic. But it may be a mistake to give the impression that the threat is over. The easing of cases may represent only a lull in the spread of covid, and variants might still be lurking.
  • A key strategy for curtailing the virus is getting more people around the world vaccinated. A report in The New York Times this week that pointed out drugmaker Johnson & Johnson had closed its vaccine manufacturing plant highlights the challenges.
  • The overall effort to spread vaccine use in underdeveloped countries is hampered by vaccine hesitancy in some of those places, difficult distribution issues, and the need for more vaccine or cash donations from rich countries.
  • HHS Secretary Xavier Becerra seems to have raised his profile in the past couple of weeks following news reports noting he had not played much of a role in the fight against covid.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read, too.

Julie Rovner: KHN’s “Ready for Another Pandemic Malady? It’s Called ‘Decision Fatigue,’” by Jenny Gold

Joanne Kenen: The New Yorker’s “What Happened After the Chicken-Pox Vaccine?” by Jessica Winter

Sarah Karlin-Smith: Stat’s “Despite Biden’s Big Promises and a Far Better Understanding of the Virus, Covid-19 Is Still Raging Through the Nation’s Prisons,” by Nicholas Florko

Anna Edney: Reuters’ “Special Report: Inside J&J’s Secret Plan to Cap Litigation Payouts to Cancer Victims,” by Mike Spector and Dan Levine

Also discussed on this week’s podcast:

The 19th’s “Experts Say Biden Could Use Executive Powers to Protect Abortion Access,” by Shefali Luthra

The New York Times’ “J.&J. Pauses Production of Its Covid Vaccine Despite Persistent Need,” by Rebecca Robbins, Stephanie Nolen, Sharon LaFraniere, and Noah Weiland

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