OIG Accelerated Approval Report Spotlights Financial Costs Ahead Of Congressional Debate
First OIG report on FDA’s accelerated approval program as part of Aduhelm-spurred review doesn’t break new ground but will likely bring new wave of focus on the costs incurred to the government when drug companies fail to complete confirmatory trials in a timely manner just as reform advocates are hoping to muster enough attention on the topic to get legislative change this year.
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The latest accelerated approval withdrawals in the US are milestones for accountability in the program – most notably with the withdrawal of an antimicrobial with confirmatory studies more than a decade overdue.
The US FDA process to force the withdrawal of the pre-term labor drug Makena is in its final stages. The product seems likely to finally leave the market – but may also demonstrate that there is a business to be built in contesting FDA withdrawal proceedings.
Accelerated Approval Reform Target? Makena Hearing Highlights Product Promotion During Withdrawal Period
Makena hearing and the product’s prolonged withdrawal process raises questions about whether FDA needs new authorities to curtail advertisement and ensure accurate patient and provider education after an accelerated approval drug’s confirmatory trial fails and/or during the period in which the agency is considering pulling the product from the market.