Conjecture

Where dying patients will accept more risk than the regulator, the regulator is rarely what stops them. FDA has authorised more than 99% of expanded-access requests, and the 2018 Right to Try Act, which took FDA out of the path, supported access to 12 products from 2018 to 2022 and 4 in 2023. The binding constraints are whether a sponsor will supply the drug and whether anyone measures what happened. Loosening approval itself on surrogate measures often does not deliver the outcome: of 46 cancer accelerated approvals with over five years of follow-up, 43% showed clinical benefit in confirmatory trials.

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