Mediocre Vaccine Could Make Pandemic Worse, Non-Profit Group Tells US FDA
Ahead of the vaccine advisory committee, requests to FDA range from public health groups opposing emergency use authorizations to industry seeking labeling guidance on EUA products.
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White House and HHS are increasing pressure on FDA Commissioner Hahn to clear Pfizer and Moderna’s COVID-19 vaccines as soon as possible – potentially skirting the advisory committee process. The move is leaving a last-minute political stain on a regulatory process the FDA fought hard to keep science-based and could foster a new wave of vaccine hesitancy amongst the American public.
Trump administration effort to reduce drug prices by curtailing agency program requiring new approvals for some old products undermines FDA’s role in policing the safety of prescription drugs, experts say.
Medicare actuaries indicate the ‘most-favored nations’ plan could limit patients’ access to medicine, though CMS’ Verma says she has confidence manufacturers won’t let that happen. Loss of access, combined with expected legal challenges, may make Democrats wary of embracing the Trump team’s last-minute rule, despite general agreement on the underlying policy idea. A Part D reference pricing policy is still in the works, CMS said.