October 4, 2023 - Washington, DC - Representative Neal Dunn (R-FL) wrote a letter to FDA Commissioner Robert M. Califf, M.D. on September 29th, demanding a substantive response to a FDA citizen petition filed by Universities Allied for Essential Medicines (UAEM).
FDA has failed to meet their federal obligations outlined in the FDA Amendments Act (FDAAA) of 2007. In the act, Congress granted the FDA responsibility and enforcement tools for ensuring clinical trial sponsors report results within a set timeframe to ClinicalTrials.gov. While these results are essential to confirm drug efficacy and ensure patient safety, minimal FDA oversight has resulted in lost clinical trial penalties of over $46 billion.
UAEM applauds Rep. Dunn's letter to Commissioner Calliff, which advocates to advance clinical trial results reporting by accepting the recommendations laid out in the citizen's petition.
UAEM’s Clinical Trial Transparency campaign lead Megan Curtin shares, “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.”
On February 27th, 2023, UAEM filed a formal citizen petition to the FDA with support from Columbia Law School’s Science, Health, and Information Clinic (SHIC). Before that filing, Rep. Frank Pallone (D-NJ) inquired about the FDA's current enforcement of the law as well. UAEM's petition calls upon the FDA to take specific actions to address the thousands of clinical trial results that remain missing from the federal database to make them available to physicians, researchers, and patients.
UAEM's petition recommends the following items for expanding FDA enforcement:
Increased issuance of annual pre-notices will inform trial sponsors of reporting failures. The FDA shared that between 2007 and 2023 the agency only sent 92 pre-notices to trial sponsors, despite there being thousands of noncompliant trials.
FDA resources should be directed towards an effective and prioritized oversight model. Clinical trials posing greater risk to human life or which lack therapeutic alternatives should be addressed prior to other trials.
Pre-notices sent to trial sponsors should be made available through a public dashboard. While the FDA publicizes notices of noncompliance, there are only a handful sent each year to trial sponsors. As a result, notices of noncompliance are an inadequate measure of FDA enforcement within the scope of the over 4,000 trials noncompliant with results reporting law. A public dashboard will give taxpayers and public health entities a better sense of their return on investment for groundbreaking new medicines.
UAEM received an interim response from FDA to their citizen petition only two days prior to the federal deadline of 180 days. The agency cites that it "will require additional time to issue its final response to your petition because of the complexity of issues raised.”
"Our hope is this letter from Congressman Dunn will help spur the agency to take action in a reasonable amount of time, rather than continuing to leave taxpayers in the dark about their enforcement," said Justin Mendoza, Executive Director of UAEM North America.
Until the FDA begins taking productive steps towards increasing clinical trial sponsor reporting compliance, UAEM will remain dedicated to its campaign for public transparency and access to essential health information.
