The potential cost to Medicare of Biogen, Inc./Eisai Co., Ltd.’s pricey new drug for Alzheimer’s disease has prompted questions regarding the US Food and Drug Administration’s leadership and the wisdom of approving a treatment that could have widespread use but is supported by tenuous evidence of efficacy, according to Senate Finance Committee Chairman Ron Wyden, D-OR.
Aduhelm Approval Raises Concerns About US FDA Leadership, Senate Finance Chair Suggests
Ron Wyden points to expectations Biogen’s drug will impose a heavy cost burden on Medicare as he questions FDA’s decision to approve aducanumab. He also expresses interest in a government-sponsored technology assessment program that could help establish the value of drugs.
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Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.
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Plan to reorganize the agency into five offices was designed by someone who does not understand the FDA, former long-time agency official Janet Woodcock says. The proposal would eliminate highly specialized expertise in favor of “a big team of generalists,” former Principal Deputy Commissioner Joshua Sharfstein says.
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Industry should be more vocal about the harms the recent reduction-in-force will have on getting drugs to market, NTEU Chapter 282 President Anthony Lee said in an interview with Pink Sheet.
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HHS Secretary Robert F. Kennedy Jr. urged FDA staff to resist the “deep state” and “crony capitalism,” and focus on improving the health of America’s children. “You're not here to take orders,” he said and urged FDA staff to speak up if they see wrongdoing.
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Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.
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The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.
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The HHS Secretary publicly acknowledged the unusual delay of Novavax's COVID-19 vaccine licensure, but his justification was neither scientifically accurate nor legally justifiable, experts said.