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Pallone Voices Concerns Over Lax FDA & NIH Enforcement of ClinicalTrials.gov Reporting Requirements

Jan 19, 2023
Press Release

Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ) wrote to Food and Drug Administration (FDA) Administrator Robert M. Califf and National Institutes for Health (NIH) Acting Director Lawrence A. Tabak today citing concerns over the lack of compliance by medical product sponsors to report clinical trial results information to the ClinicalTrials.gov database.

Federal law requires certain clinical trial sponsors to report results to ClinicalTrials.gov in order to help expand the knowledge base, support additional research, and provide important safety and efficacy information to health care providers and researchers. 

“According to a recent study, sponsors of 31 percent of registered trials required to report results have failed to report any results, and another 30 percent of sponsors of registered trials required to report results failed to do so on time, totaling 5,364 trials in violation of applicable reporting requirements, or 61 percent of such trials,” Pallone wrote to the agency leaders. “Despite these troubling results, [FDA] and NIH have only carried out limited enforcement activities for failure to comply with ClinicalTrials.gov requirements.”  

Congress originally required NIH to establish a public database of clinical trials in 1997 to help patients find trials for serious illnesses. In 2007, Congress expanded the types of trials required to register as well as the types of information required to be submitted, including clinical trial results. 

“Congress enacted these changes to increase the availability, transparency, and public scrutiny of clinical trial results, incentivize compliance, and facilitate enforcement in the event of noncompliance,” Pallone continued. “Publicly reported clinical trial results serve as a resource for safety and effectiveness information for health care providers and researchers and has led to improved report quality.” 

Both FDA and NIH have roles in enforcement of ClinicalTrials.gov requirements. NIH is responsible for funding for certain trials and has the authority to withhold future funding from grantees if the proper clinical trials information is not reported. FDA is responsible for enforcement and has authority to pursue civil monetary penalties, injunction, or criminal prosecution for noncompliance. Recent studies show that when the agencies take action, clinical trial sponsors quickly comply with requirements. However, FDA and NIH have rarely taken action to enforce clinical trials reporting requirements, and many trials remain out of compliance.

“These actions have only been taken with regard to a tiny fraction of the trials that have been or remain in violation of ClinicalTrials.gov requirements. Additionally, it appears FDA has not sent any compliance letters to NIH, despite the many trials NIH runs or oversees,” Pallone concluded. “FDA has also not yet imposed any civil money penalties on any trial sponsors. The collection of these penalties would provide a stronger incentive for trial sponsors to comply.”

As part of his letter, Pallone requested FDA and NIH respond to a series of questions included in the letter by February 17, 2023.

Read the full letter HERE.

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