FDA hit by massive cuts that could lead it to miss PDUFA goals

Mass layoffs and organizational changes at the FDA, announced Thursday by HHS Secretary Robert F. Kennedy Jr., will slow medical product reviews and inspections, disrupt communication with drug developers, patients and the public, and impair the agency’s ability to keep pace with rapidly advancing science, according to current and former senior FDA officials.

The staffing cuts, amounting to roughly 18% of FDA’s total workforce, were devised by Acting FDA Commissioner Sara Brenner and a small group that excluded the directors of FDA’s centers and offices, as well as key staffers like Office of New Drugs Director Peter Stein, who would ordinarily be involved in making these kinds of plans, BioCentury has learned...