KHN’s ‘What the Well being?’: FDA takes heart stage

The FDA continues to be missing a Senate-confirmed chief, however the company is on the heart of a number of main coverage battles. Lawmakers this 12 months should renew the invoice that authorizes drug corporations to pay “consumer charges,” which allow the company to rent extra reviewers to hurry the approval of medication. The FDA can be more and more concerned within the abortion debate and the trouble to deal with the thousands and thousands of Individuals with Alzheimer’s illness.

In the meantime, states led by Democrats are beginning to calm down some covid restrictions, at the same time as officers on the Facilities for Illness Management and Prevention complain it is too quickly.

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

Among the many takeaways from this week’s episode:

  • Congress is starting the method of renewing the 30-year-old Prescription Drug Person Charge Act (PDUFA). Though drugmakers initially had been hesitant concerning the PDUFA program, they now help it as a result of it has significantly lower the time for FDA approval.
  • Some specialists argue, nevertheless, that the additional cash generated by the PDUFA program must also be used to judge how medicine are working after they’re accepted and basically use.
  • Key Home Republican lawmakers despatched a letter this week to the Division of Well being and Human Providers criticizing Medicare’s choice to restrict using Aduhelm, a controversial drug for Alzheimer’s illness that received conditional approval from the FDA final fall. Medicare has agreed to cowl the $28,000-a-year price ticket just for beneficiaries in a medical trial that research the drug’s results. The Republicans argued it could be unfair for Medicare to restrict Aduhelm’s use.
  • Current strikes by state leaders to finish masks mandates and different covid prevention measures come as a lot of the general public continues to develop weary of the pandemic. However it could be a mistake to present the impression that the menace is over. The easing of instances might characterize solely a lull within the unfold of covid, and variants would possibly nonetheless be lurking.
  • A key technique for curbing the virus is getting extra folks around the globe vaccinated. A report in The New York Occasions this week that identified drugmaker Johnson & Johnson had closed its vaccine manufacturing plant highlights the challenges.
  • The general effort to unfold vaccine use in underdeveloped nations is hampered by vaccine hesitancy in a few of these locations, troublesome distribution points, and the necessity for extra vaccine or money donations from wealthy nations.
  • HHS Secretary Xavier Becerra appears to have raised his profile previously couple of weeks following information experiences noting he had not performed a lot of a task within the battle in opposition to covid.

Plus, for additional credit score, the panelists advocate their favourite well being coverage tales of the week they suppose it’s best to learn, 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

Additionally mentioned on this week’s podcast:

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

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

Kaiser Health NewsThis text was reprinted from with permission from the Henry J. Kaiser Household Basis. Kaiser Well being Information, an editorially unbiased information service, is a program of the Kaiser Household Basis, a nonpartisan well being care coverage analysis group unaffiliated with Kaiser Permanente.



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