The corruption of the FDA's scientific culture is driving the deterioration of safety and effectiveness standards, David Ross, MD, associate clinical professor of medicine at Washington, D.C.-based George Washington University School of Medicine and Health Sciences, wrote in an opinion piece for The BMJ on May 15.
Dr. Ross outlined a recent FDA approval of a drug called Recarbrio.
"Approval of the Recarbrio NDA was shocking given its lack of substantial evidence of effectiveness and the complete absence of adequate and well controlled clinical investigations on the actual indication of interest," Dr. Ross wrote. "The Recarbrio approval is even more troubling because of other inexplicable departures from fundamental scientific, regulatory and procedural principles. These included the failure to require 'that each active component [of a fixed dose combination drug] contributes to the effect claimed for the product.'"
Dr. Ross pointed to the FDA's reliance on industry paid user fees as a reason for the corruption he sees. According to the article, in 1994, fees made up less than 10 percent of the FDA's annual drug budget. In 2023, fees made up more than two-thirds.
"In its quest to avoid difficult choices and hard decisions, the FDA has increasingly embraced non-inferiority trials (or vice versa), ignoring the serious regulatory, clinical and ethical problems caused by their misuse," Dr. Ross wrote. "However, the corruption of the FDA's scientific culture remains the primary culprit driving the deterioration of safety and effectiveness standards … FDA leadership's continued hostility towards meaningful peer review, transparency, and accountability dims the prospect for institutional self-renewal. So has the failure of much-touted internal pathways for disagreement, which have amounted to little more than virtue signaling."
Regarding a potential solution, Dr. Ross called on Congress to adequately fund the FDA so its dependency on user fees would decrease.
"Although politically fraught, tapering the FDA's dependence on user fees would involve less than 0.2 percent of the annual federal budget," Dr. Ross wrote. "This would be a small price to pay for checking the continuing corrosion of the agency's scientific integrity by user fees."
He also recommended improving public access to the information received by the FDA, its reasoning and its decisions.
"Fifty years ago, the agency issued regulations providing broad authority to disclose safety and effectiveness data," Dr. Ross wrote. "Subsequently, however, the FDA reinterpreted its authority under the Freedom of Information Act to significantly narrow the scope of information it would release. Its continuing refusal to disclose non-trade secret information, such as the effectiveness data in the Recarbrio NDA, is untenable given the FDA's existing authorities and its ability to implement congressionally mandated transparency reforms, such as the requirement to post NDA action packages to the FDA's website within 30 days of approval, without having to promulgate new regulations."