A Republican congressman has raked the FDA over the coals for failing to enforce a law requiring clinical trial results to be made public.
In a letter to the FDA, he noted that:
“To date, more than 4,000 clinical trials… are missing results due to deficiencies in reporting and an inadequate FDA response to date…”
“FDA’s limited enforcement of [law] FDAAA has been examined in an Office of Inspector General August 2022 report, a January 2023 letter from Representative… Frank Pallone, and an April 2023 report from the Government Accountability Office.”
“FDA must… take action to address the backlog of thousands of trials with overdue and missing results.”
Clinical trial results that remain hidden from public view leave dangerous gaps in the medical evidence base that harm patients, waste public funds and undermine public health.
Clinical trial transparency law FDAAA was passed by Congress in 2007 with overwhelming bipartisan support.
In September, the FDA had missed the deadline for responding to a citizen petition filed by student advocacy group Universities Allied for Essential Medicines (UAEM) that set out three steps that the FDA should take to get on top of the problem. The Congressman urged the FDA to take those steps.
UAEM’s clinical trial transparency campaign lead Megan Curtin said:
“Congressional leaders from both parties have now called upon the FDA and NIH for swift action. While the NIH has placed contingencies on clinical trial funding for timely results reporting, the FDA promotes voluntary compliance. The FDA should make an effective commitment to timely results reporting by enacting the recommendations in our citizen petition.”
The congressman who wrote the letter, Dr. Neal Dunn, is a medical professional.
According to his bio:
Dr. Dunn was a surgeon in Panama City for 25 years and was the founding president of the Advanced Urology Institute, a 45-physician practice with over 400 employees. He also founded the Bay Regional Cancer Center and pursued a special interest in advanced Prostate Cancer. He sat on the Governor's Prostate Cancer Advisory Council and the Florida Blue Physician Advisory Board. Prior to being elected to Congress, Dr. Dunn served on the Board of Governors of the Florida Medical Association, and as President of his County Medical Society, Chief of Staff of Gulf Coast Hospital, and Director of the Bay Medical Center Sacred Heart Joint Venture. He was recognized as a Healthcare Hero by the Florida Department of Health for his chairmanship of Bay Cares, a medical charity headquartered in Panama City that provided about $30 million of completely free medical care annually to the working poor in Bay and 8 surrounding counties.