Rep. Frank Pallone wants FDA and NIH to act on pharma's noncompliance with trial records law
Frank Pallone, ranking member of the House Energy & Commerce Committee, criticized the FDA and NIH today for not doing enough to prevent pharma companies from failing to report certain clinical trial results to the government database, ClinicalTrials.gov.
Pointing to a recent study, Pallone said that while compliance with ClinicalTrials.gov reporting requirements “has slowly but steadily improved since 2007, significant gaps remain.”
In a 2021 study of all registered trials completed after January 2017, sponsors of only 40% of trials required to report results did so within one year of completion, as required by law, and under 69% did so at any time.
“FDA, which bears responsibility for enforcing ClinicalTrials.gov requirements for a much larger number of trials, has also taken very limited action to ensure compliance,” Pallone wrote. “This is concerning considering that it is apparent when FDA takes action, it has great effect. FDA first began issuing Pre-Notice letters in 2013, six years after FDAAA was enacted.”
Pallone also questioned FDA, given the large number of trials that appear to be noncompliant and the success of FDA’s noncompliance letters so far, whether the agency plans to send these letters more frequently in the future. And if not, why not?
The letter comes as most NIH-funded clinical trials with results due in 2019 and 2020 did not meet federal reporting requirements, the HHS inspector general’s office said in an audit released last August.
“NIH did not have adequate procedures for ensuring that responsible parties submitted the results of clinical trials, took limited enforcement action when there was noncompliance, and continued to fund new research of responsible parties that had not submitted the results of their completed clinical trials,” HHS’ OIG report says.
Pallone later questioned if the process by which FDA reviews these noncompliant sponsors should be different, noting:
Is it necessary to conduct an inspection or receive a complaint to determine whether a sponsor or trial is subject to and in compliance with ClinicalTrials.gov requirements, or is FDA able to more efficiently determine this through other means, such as review of sponsor submissions or communications with sponsors.