The FDA’s Peter Marks was at the forefront of the race to develop Covid-19 vaccines. Now, with Operation Warp Speed for Rare Disease, he’s advocating for speeding up the amount of time it takes potentially lifesaving gene therapies to get to market. That means making adjustments to the FDA’s review process, including using accelerated approval more aggressively and encouraging more direct communication between reviewers and biotech companies. The approach has its critics, but Marks sees the possibility that the FDA could approve a therapy that’s later found not to be beneficial as worth the tradeoff. “I won’t lose sleep over that,” he told STAT this January.
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