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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Makena’s Reimbursement Coverage Remained Unchanged After Confirmatory Trial Failure
As milestone approaches in FDA effort to pull the pre-term birth drug, the findings suggest that by leaving Makena on the market, the agency may be ‘furthering plan inaction,’ Tufts Medical Center researchers conclude.
US FDA’s Post-Aduhelm Reforms Include Updated Alzheimer’s Development Guidance, Record-Keeping On Sponsor Meetings
Agency already had an action plan in hand to address concerns with the aducanumab review even before the controversial approval, but it has not been fully implemented yet. A House committee report is another nudge.
The Long And Short Of Accelerated Approval Accountability In US
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.