Pink Sheet Podcast: Coronavirus Vaccine Trial Designs, US FDA Approval Trends While Teleworking, Price Increases And The Part D Donut Hole Fix
Pink Sheet reporters and editor discuss CBER Director Marks’ ideas for coronavirus vaccine clinical trials, changes in FDA approval volume under the teleworking order, and a study of the Medicare Part D donut hole fix.
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Yes, Gottlieb’s in there twice; things get complicated when an agency starts to lose credibility.
CARES Act appears to have overlooked Medicare coverage of a vaccine not granted traditional approval by US FDA. Meanwhile, other patient and provider vaccine reimbursement issues still need to be addressed by HHS and Congress to ensure widespread, affordable access to COVID-19 vaccines cleared by FDA under any pathway.
A more conservative US Supreme Court may mean a less authoritative FDA, and drug pricing won’t get as much attention in the presidential campaign, which is a good thing.