KHN’s ‘What the Well being?’: FDA Takes Heart Stage



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The FDA continues to be missing a Senate-confirmed chief, however the company is on the middle of a number of main coverage battles. Lawmakers this yr should renew the invoice that authorizes drug corporations to pay “consumer charges,” which allow the company to rent further reviewers to hurry the approval of medication. The FDA can be more and more concerned within the abortion debate and the hassle to deal with the hundreds of thousands of People 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’s 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 Consumer Payment Act (PDUFA). Though drugmakers initially have been hesitant concerning the PDUFA program, they now assist it as a result of it has significantly lower the time for FDA approval.
  • Some consultants 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 on the whole use.
  • Key Home Republican lawmakers despatched a letter this week to the Division of Well being and Human Providers criticizing Medicare’s resolution 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 scientific trial that research the drug’s results. The Republicans argued it could be unfair for Medicare to restrict Aduhelm’s use.
  • Latest 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 risk is over. The easing of circumstances could 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 world wide 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 international locations 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 international locations.
  • HHS Secretary Xavier Becerra appears to have raised his profile up to now couple of weeks following information stories noting he had not performed a lot of a task within the battle in opposition to covid.

Plus, for further 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 “Prepared for One other Pandemic Illness? It’s Referred to as ‘Resolution Fatigue,’” by Jenny Gold

Joanne Kenen: The New Yorker’s “What Occurred After the Rooster-Pox Vaccine,” by Jessica Winter

Sarah Karlin-Smith: Stat’s “Regardless of Biden’s Massive Guarantees and a Far Higher Understanding of the Virus, Covid-19 Is Nonetheless Raging Via the Nation’s Prisons,” by Nicholas Florko

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

Additionally mentioned on this week’s podcast:

The nineteenth’s “Consultants Say Biden May Use Government Powers to Shield Abortion Entry,” by Shefali Luthra

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


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