FDA abandons expert reviews of new drugs, risking public health

In recent months, the U.S. Food and Drug Administration (FDA) has taken steps to move away from advisory committee meetings that have traditionally played a vital role in reviewing new drugs. George Tidmarsh, head of the FDA's Center for Drug Evaluation and Research, expressed that these panels are redundant and overly burdensome to both the FDA and the companies involved. This shift has ignited concern from former FDA officials and academics who underscore the importance of expert input in the drug review process, claiming that such discussions help to enhance decision-making transparency and public understanding. They argue that without these advisory meetings, which allow for public deliberation among experts, the integrity of the drug evaluation process could be compromised. FDA Commissioner Marty Makary, who previously supported advisory meetings, has since opted for a model where he selects specified scientists to advise on particular issues, thereby raising questions regarding the objectivity and diversity of opinions in drug evaluations. Critics warn that consolidating power within the FDA without the checks provided by external expert review could detract from drug safety and accountability.