FDA’s Marks Issues ‘Provocative’ Call for Target Gene Therapy Profile That Includes Costs
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Sep 12, 2024
The Food and Drug Administration’s top gene therapy regulator issued what he acknowledged is a “provocative” call to consider setting a “target product profile” for gene therapy that includes not just what is expected from a clinical perspective, but “what we need to expect out of them from an economic perspective and from a clinical benefit perspective versus cost perspective.”
The FDA, by virtue of legal mandates and historical precedent, tends to avoid discussing the costs of novel medical interventions. But when a senior leader like Center for Biologics Evaluation and Research Director Peter Marks discusses cost-effectiveness tradeoffs, eyebrows raise.
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