FDA Updates Rules for Accessing Trial Drugs in Crises
Published Date: 11/17/2025
Notice
Summary
The FDA just released new, easy-to-understand rules about how patients can get access to experimental drugs when no other treatments work. This update affects doctors, drug makers, and patients by clarifying the process and replacing old guidance from 1998. The new rules are effective starting November 17, 2025, and aim to speed up access without extra costs or delays.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Final FDA Expanded Access Guidance
The FDA published final guidance titled "Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers" on November 17, 2025. It finalizes the November 2, 2022 draft and replaces the 2016/2017 guidance, clarifying how patients and doctors can pursue access to investigational drugs when no other treatments work and stating the guidance is deregulatory in nature.
Clarified Consent and Submission Steps
The final guidance includes additional clarifications related to informed consent and the process for submission of expanded access requests. Those clarifications were added between the November 2022 draft and this final guidance and take effect with the guidance announced on November 17, 2025.
Manufacturers Must Publish Access Policies
Under section 561A of the FD&C Act (as amended by the Cures Act) and FDARA, a manufacturer or distributor must make its expanded access policy readily available to the public (for example, by posting it on a website). The policy must be posted by the earlier of the first initiation of a phase 2 or phase 3 study for the drug or within 15 days after the drug receives a fast track, breakthrough, or regenerative advanced therapy designation.
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