Any future FDA Commissioner will have to face eroding trust in our public health institutions. Accelerated approval accounts for a minority of approvals but encapsulates trends feeding mistrust, making a good starting point to restoring FDA’s credibility.
www.healthaffairs.org/content/fore...
New from Institute for Clinical and Economic Review (ICER) and Verdant Research: We revisited our 2021 white paper on FDA's accelerated approval pathway.
icer.org/news-insight...
It was a good moment to learn about what's improved and where we have unfinished business. We found that changes following FDORA have been largely well received - encouraging news that reform to improve performance works!
But significant challenges remain around evidence quality, transparency, and financial incentives. These boil down to a one theme that is now familiar in our political discourse: trust, and the lack thereof.
A lot changed in the 5 years since that report. FDORA gave FDA new enforcement tools. The agency issued updated guidance on surrogate endpoints and confirmatory trials and initiated a number of withdrawals. And the new administration has fundamentally reshaped the regulatory environment.
We identified a number of ways to rebuild that trust and hope to share those ideas with you.
icer.org/news-insight...
For serious conditions with high unmet need, earlier access to promising treatments can be worth the risk of greater uncertainty. But achieving this balance demands trust.
Scoop: Vinay Prasad is out at FDA. HHS spokesperson said "he did not want to be a distraction to the great work of the FDA in the Trump administration."
Story TK in Pink Sheet.