Reporting has surfaced that senior FDA leaders and staff have expressed concerns about a newly implemented expedited drug program, including who should sign final approvals and whether normal review steps were bypassed for at least one product. The coverage indicates internal discomfort and legal questions about governance and accountability for accelerated pathways. Sources cited in the item report management reluctance to assume sign-off responsibility and suggest the program’s procedural flexibility has raised compliance and oversight flags. The story underscores potential regulatory risk for sponsors relying on the expedited route and signals heightened scrutiny by industry and watchdogs as the program matures.