FDA’s Fast-Track Drug Vouchers Spark Sign-Off Scrutiny

AP reports that FDA Commissioner Marty Makary’s voucher-based effort to accelerate drug approvals into a one-month window has stirred alarm inside the agency. Questions swirl over who has legal authority to sign off on these expedited approvals, with senior officials and political appointees increasingly involved in the process, diverging from the traditional scientist-led review. The program, not codified in federal rules and now expanded to 18 vouchers, has coincided with staff layoffs and leadership turnover, fueling concerns about politicization, safety standards, and potential legal risk for the agency as critics warn that such rapid reviews lack scientific precedent.