March 11, 2024
In 2007, Congress passed the FDA Amendments Act (FDAAA) requiring clinical trials funded by the NIH to submit results to ClinicalTrials.gov. The law also enables FDA to fine non-compliant responsible parties of up to $10,000 per day. However, over 5,000 trials remain non-compliant or missing from the federal database and the FDA has never issued civil money penalties.
In response, UAEM pursued a Freedom of Information Act (FOIA) request investigation to determine the scope and efficacy of current FDAAA enforcement. In partnership with Columbia Law School’s Science, Health, and Information Clinic (SHIC) and Congressional offices, UAEM received the following documents detailing how the FDA and NIH enforce clinical trial results reporting and address cases of non-compliant responsible parties.
-
In March 2021, UAEM filed a FOIA request for email communications the FDA sent to non-compliant responsible parties. The following documents reveal extended delays between missed results submission deadlines and the issuances of Preliminary Notices of Noncompliance (Pre-Notices) and Notices of Noncompliance. The contents of the Pre-Notices produced through the FOIA request show that the FDA does not consistently share clear enforcement timeframes for trial sponsors to understand potential penalties for delayed results submissions.
During the same month, UAEM filed a FOIA request with the NIH. The resulting documents reveal the NIH’s internal clinical trial results reporting enforcement plans and related correspondence to non-compliant responsible parties. This request also clearly shows that the NIH is aware of the success of Pre-Notices in generating rapid compliance.
-
In October 2022, Senators Marsha Blackburn, Charles Grassley, Ron Johnson, and Roger Marshall, sent a letter to the NIH demanding the agency provide a response as to how it will address outstanding noncompliance discovered in the OIG audit. UAEM filed a FOIA request for the NIH’s response to these Congressman, wherein the agency commits to strengthening evaluation mechanisms ClinicalTrials.gov.
-
The 2023 Section 2052 report of the 21st Century Cures Act, outlining ClinicalTrials.gov oversight and compliance activities at the FDA and NIH. These documents demonstrate that the FDA and NIH are knowledgeable of widespread noncompliance. While the NIH provides clear commitments towards strengthening oversight, the FDA does not describe any intentions to increase exercising its regulatory authority.
-
In January 2023, Ranking Member of the House Energy and Commerce Committee Frank Pallone partnered with UAEM to write a letter to the FDA and NIH inquiring about noncompliance in results reporting.
-
In April 2023, the FDA and NIH provided an interagency response discussing the effectiveness of current regulatory efforts and steps to address outstanding noncompliance. The FDA made no commitment towards increasing the issuance of Notices and wrote that failure to comply with reporting requirements would not prevent licensing, approval, or clearing of marketing applications. However, the NIH presented a stronger commitment to enforcement, outlining actionable steps taken to monitor cases of noncompliance through developing new guidance on enforcement of results reporting and potentially withholding grants from responsible parties who fail to meet reporting requirements.
-
In September 2023, UAEM worked with Congressman Neal Dunn to write a letter to the FDA Commissioner specifically recommending that the FDA implement the enforcement actions outlined within UAEM’s Citizen Petition.
-
In November 2023, the FDA replied to Congressman Dunn. The agency acknowledged that it had not fully responded to UAEM’s Citizen Petition at the time, without making a commitment towards implementing UAEM’s requests. However, within a week of responding to Congressman Dunn, the FDA implemented one of UAEM’s requests in the Citizen Petition by publishing a public dashboard of issued Pre-Notice letters to non-compliant responsible parties.
