FDA Prioritization Program Stalls: Safety Concerns Cause Delays

The FDA has delayed reviews of drugs under its fast-track program due to safety and efficacy concerns, including trial data issues and adverse events. This includes Disc Medicine's rare blood disorder drug and Sanofi's type 1 diabetes drug. The delays raise concerns about the program's rigor and potential politicization.

The U.S. Food and Drug Administration has postponed the review of two drugs in its new fast-track initiative due to safety and efficacy reservations. These include Disc Medicine's treatment for a rare blood disorder and Sanofi's diabetes drug, Tzield, attributed with adverse effects, including patient deaths.

Documents reveal these review delays were unexpected, with FDA reviewers extending timelines by weeks to months. The fast-track program, launched by the Trump administration, intended to cut approval times to one or two months for critical drugs, but recent developments suggest more exhaustive scrutiny is now being exercised.

Regulatory experts see the delays as a positive indication of due diligence, despite initial concerns that political factors might influence drug approvals. While the FDA's approach seeks to balance expedited reviews with caution, companies like Disc Medicine and Sanofi collaborate closely with the agency to resolve the flagged issues.

(With inputs from agencies.)