WSJ Opinion: Potomac Watch Vinay Prasad Is Leaving the FDA / Anthropic Sues the Pentagon
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Mar 10, 2026 A departing FDA regulator and the controversies around approval standards for gene and rare-disease therapies take center stage. A biotech company sues the Pentagon over a supply-chain risk label tied to surveillance and autonomous weapons. Debate centers on trial design, patient harm, and how defense contracts shape AI use and policy.
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Prasad Raised Evidence Bar Causing Rare Drug Pushback
- The FDA's biologics chief Vinay Prasad pushed for higher evidence standards that critics say block rare-disease and gene therapies.
- Alicia Finley cites Sarepta and other rejections where Prasad moved goalposts, prompting congressional scrutiny and patient backlash.
Clinician Testimony Of Patients Forced Off Effective Drugs
- Harvard neurologist Jeremy Schmahmann described writing six letters and meeting FDA staff who ignored clinicians about a drug benefiting 300 patients.
- He warned a placebo-controlled or withdrawal trial would force patients off therapy and could cause deaths.
Rigid Review Culture Harms Rare Disease Approval
- Critics argue FDA staff are rigid and Prasad personally overruled staff to reject drugs that reviewers supported.
- Alicia Finley says this rigidity is especially harmful for rare diseases where conventional trials are impractical or unethical.