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Weekend Reading: FDA’s Rollout of Plasma EUA Draws Skepticism
Scientists react negatively to FDA's handling of the Emergency Use Authorization for convalescent plasma in COVID-19.
Sunday’s announcement from FDA of an Emergency Use Authorization (EUA) for the use of blood plasma from those recovered from coronavirus disease 2019 (COVID-19), as a treatment for patients soon after COVID-19 symptoms appear, brought intense reaction from scientists, on Twitter and beyond.
Even physicians who favor studies of convalescent plasma as a treatment for COVID-19 winced at the scene of President Donald Trump announcing a “major therapeutic breakthrough,” with HHS Secretary Alex Azar and especially FDA Commissioner Stephen Hahn, MD, in tow. Not lost on anyone was the fact that days earlier, Trump had accused a mythical FDA “deep state” of moving too slowly on COVID-19. In particular, Hahn’s claim Sunday that plasma with certain antibodies had produced a 35% reduction in mortality rate raised questions, because the source supporting that statement was not immediately clear. STAT News reported that an FDA staff member whose name was left off a memo tempered his enthusiasm.
Ashish Jha, MD, director of Harvard’s Global Health Institute, tweeted that while FDA had the authority to issue the EUA and the “data might even meet the criteria,” the “hyperbole” and overselling of the evidence by Hahn was “very disappointing” and would make clinical trials more challenging. FDA’s credibility took a “big hit,” Jha said.
Meanwhile, former Commissioner Scott Gottlieb, MD, offered his former colleagues a partial defense, saying he firmly rejected Trump’s claims that FDA was “slow walking” coronavirus treatments. Gottlieb tweeted that he was “confident in the science part of the evaluation,” from FDA. He continued: “The way the public part was handled will erode precious public confidence. You earn public confidence in small drops and you lose it in buckets.”
Upended: Can PBM Transparency Succeed?
March 6th 2024Simmering tensions in the pharmacy benefit management (PBM) industry have turned into fault lines. The PBMs challenging the "big three" have formed a trade association. Purchaser coalitions want change. The head of the industry's trade group says inherent marketplace friction has spilled over into political friction.
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In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
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Inflation Reduction Act: Reforms to Patient Cost-Sharing
September 18th 2023Lower out-of-pocket costs for patients might put upward pressure on drug prices, as manufacturers face less price sensitivity, note Matthew Majewski and Rhett Johnson of Charles River Associates. But they also note that upward pressure on price is likely to be limited to the inflation rate as any additional price increase would need to be paid back to CMS in the form of inflation rebates.
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Spending climbed by 2.7% in 2021. In 2020, it soared by 10.3%, fueled by federal government spending in response to the pandemic. The blizzard of calculations of 2021 healthcare spending by CMS’ actuaries also provides further evidence that utilization of healthcare services bounced back in 2021.
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