In a brief recent article in the British Medical Journal,1 associate clinical professor of medicine David Ross from the George Washington University highlights a troubling ‘corruption of the FDA’s scientific culture’.
He does so using the example of the approval of the drug Recarbrio by the US Food and Drug Administration (FDA) in 2019. After the thalidomide safety disaster, any FDA approval of a new drug requires proof of ‘substantial evidence’ of safety and effectiveness. The legally enforceable regulations are designed to assure ‘prescribers, patients and payers that effectiveness claims are based on science, not science fiction’.
Ross explains the FDA’s subversion of ‘the legal standard for effectiveness’ in the 2019 approval of Recarbrio with reference to the rising share of user fees, paid by the drug industry, in the FDA’s annual budget, up from less than one-tenth in 1994 to over two-thirds in 2023.
Institutional renewal of the FDA thus requires tapering its dependence on user fees and also greater transparency with improved public access to the information received by the FDA, its reasoning, and its decisions. Otherwise, we risk returning ‘to an era when drug effectiveness was an afterthought.’
1 BMJ 2023; 381 doi: https://doi.org/10.1136/bmj.p1061 (Published 15 May 2023)