The FDA has suspended evaluation of Disc Medicine's experimental drug bitopertin under the accelerated approval program "National Priority Voucher Program", introduced in June 2025 during the first administration of Donald Trump.[1] The program promised decisions within 1–2 months, cutting the process by 4–6 months from the standard.[1] The FDA questions whether "pain-free time in a relaxed outdoor environment" as a secondary endpoint of a clinical trial is a statistically reliable measure of efficacy or merely reflects a better psychological state of patients.[1] The agency is requesting additional biomarker-based data to confirm that reductions in toxic metabolites lead to measurable therapeutic benefits.[1] The decision is significant due to patient deaths and serious adverse events, including seizures in December 2024 and September 2025 and thromboembolic complications in May 2025.[1] Shares of Disc Medicine fell more than 7% following the announcement.[1]