FDA Delays Highlight Safety Concerns in Fast-Track Drug Program

The FDA postponed reviews for two drugs in the Trump administration's fast-track program due to safety and efficacy concerns. A patient death and adverse events raised red flags about the medicines' approval. The program, which promises quicker decisions, faces scrutiny for potentially compromising rigorous evaluations.

The U.S. Food and Drug Administration has recently postponed its reviews for two experimental drugs that were selected under the Trump administration's expedited approval program. The delays stem from safety and efficacy concerns, particularly following the reported death of a patient taking one of the drugs, according to internal documents accessed by Reuters.

The FDA extended its review of Disc Medicine's drug for a rare blood disorder by two weeks, citing concerns over trial data and potential abuse risks. Sanofi's Tzield, intended for late-stage type 1 diabetes, faced a more than one-month stall due to adverse reports, including seizures and blood clotting incidences, one of which resulted in death.

The delays, not previously publicized, have sparked discussions about the program's balance between speed and safety. Regulatory experts expressed relief that the FDA is exercising caution, despite the pressures of the program's ambitious timelines, which aim to cut four to six months from the conventional priority approval process.

(With inputs from agencies.)