FDA criticised for neglect and lack of enforcement
The Food and Drug Administration (FDA) in the USA is the most powerful medicines regulatory agency in the world, however a new report is critical of the FDA’s neglect in enforcing clinical trial transparency, overlooking $45 billion in fines and calling for more aggressive enforcement of the law. Thousands (and counting) of trials are not reporting results as required by law.
When patients enrol in clinical trials, they reasonably assume that the research results will be shared with the public, physicians, and fellow patients. In 2019, however, our organization, Universities Allied for Essential Medicines (UAEM), found that the top U.S. universities were failing to report their results to a public database on time — and flagrantly violating federal law in the process. Unfortunately, this problem is not a new one, and neither is the FDA’s lack of urgency in solving it.
After we published our report, several universities responded by immediately submitting their overdue trial results. This suggested that the problem was not the difficulty of complying with the law, but the fact that it was rarely enforced. Two years later, we found that while university compliance with the law improved following advocacy efforts, trial sponsors were still broadly failing to prioritize access to research results, including for trials concerning FDA-approved therapies. Our findings raised serious concerns. For physicians and patients seeking to make informed decisions about the safety and value of expensive new therapies, access to results is critical.
Today, over 5,000 clinical trials are in violation of federal reporting requirements that requires timely results reporting to the ClinicalTrials.gov database. Under the relevant act, FDA and NIH share the responsibility to ensure that sponsors of clinical trials report their results in a timely manner.
To date, the FDA could have imposed over $45 billion in fines. In spite of the thousands of trials violating the law, the FDA has not yet collected any fines.
With the aim of urging that action, UAEM recently filed a formal citizen petition to the FDA, with support from Columbia Law School’s Science, Health, and Information Clinic. Our petition asks the FDA to take specific steps that will close the gap of thousands of trial results that remain unavailable to patients, clinicians, researchers, and the public.
By increasing and optimizing its enforcement of the law, the FDA can grow access to potentially lifesaving information for patients, physicians, and researchers. It’s time for the FDA to act.
SOURCE: MEDPAGE TODAY March 21, 2023
FDA Has Neglected Clinical Trial Transparency
by Megan Curtin, Navya Dasari, Justin Mendoza, MPH