LSHC Horizons Brochure 2024 - Flipbook - Page 37
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Clinical Trials
Update on FDA enforcement of ClinicalTrials.gov requirements
U.S. federal law requires sponsors of certain
clinical trials to register and post results of their
studies on ClinicalTrials.gov. If a sponsor fails
to submit the required registration or results
information for a study to ClinicalTrials.gov,
FDA may issue a Preliminary Notice of NonCompliance, which allows sponsors 30 days
to bring their study record into compliance.
If a sponsor does not address the violations
identified by FDA, then the agency can take
further enforcement action, which can include
issuing a Notice of Non-Compliance, civil
monetary penalties, injunction, and
criminal prosecution.
Although penalties for ClinicalTrials.gov
non-compliance can be significant, FDA’s
enforcement of ClinicalTrials.gov requirements
has to-date been quite light. Since 2021,
FDA has only issued five Notices of NonCompliance to clinical trial sponsors for failing
to submit clinical trial results. FDA’s lack
of enforcement has been noted by the U.S.
Congress, with the Energy and Commerce
Committee sending a letter to FDA in January
2023 expressing concern with FDA’s “limited
enforcement activities for failure to comply
with ClinicalTrials.gov requirements.” The
letter pointed to a study that found widespread
non-compliance with ClinicalTrials.gov results
submission requirements, with 31 percent
of trials failing to report required results,
and another 30 percent of trials failing to
Robert F. Church
Partner
Los Angeles
report required results on time. The letter
noted that FDA had not yet imposed any civil
monetary penalties for non-compliance with
ClinicalTrials.gov requirements, even though
such penalties “would provide a stronger
incentive for trial sponsors to comply."
There are some recent signs, however,
that FDA may be taking a closer look at
ClinicalTrials.gov compliance. In December
2023, FDA commissioner Dr. Robert Califf
issued a statement describing FDA’s oversight
of ClinicalTrials.gov and the actions FDA has
taken to address non-compliance. Dr. Califf
stated that FDA was “committed to promoting
clinical trial transparency and will continue to
advance our compliance activities related to
the ClinicalTrials.gov database.” In addition to
Dr. Califf’s statement, FDA released a report in
January 2024, in collaboration with the Clinical
Trials Transformation Initiative, investigating
factors and barriers to registration and results
reporting on ClinicalTrials.gov and offering
suggestions for improvement. We at Hogan
Lovells will continue to monitor the agency’s
actions to see if FDA is indeed preparing to
take a stronger stance on ClinicalTrials.gov
enforcement.
Bert Lao
Counsel
Los Angeles
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