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The Food and Drug Administration (FDA) has done little to enforce the reporting requirements for clinical trials.[1] The basic requirements are straightforward: to register clinical trials and report the results to ClinicalTrials.gov at the National Institutes of Health under the FDA Amendment Act of 2007 (FDAAA) and clarifying regulations effective in 2017 (the Final Rule). According to the FDAAA Trials Tracker, as updated in February 2024, only 16,135 (77.4%) of 20,855 trials covered by the...
The Food and Drug Administration (FDA) has done little to enforce the reporting requirements for clinical trials.[1] The basic requirements are straightforward: to register clinical trials and report the results to ClinicalTrials.gov at the National Institutes of Health under the FDA Amendment Act of 2007 (FDAAA) and clarifying regulations effective in 2017 (the Final Rule). According to the FDAAA Trials Tracker, as updated in February 2024, only 16,135 (77.4%) of 20,855 trials covered by the legal requirements had reported their results.[2] As of December 2023, the FDA had sent only five notices of noncompliance to trial sponsors and has never imposed any fines on a sponsor who is noncompliant even though it has the authority to do so.[3]
In February 2023, as previously discussed in the December 2023 issue of Worst Pills, Best Pills News,[4] the Universities Allied for Essential Medicines North America filed a citizen petition with the FDA to increase enforcement of the ClinicalTrials.gov reporting requirements and impose fines when appropriate.[5] Among the specific requests was that the agency send a minimum of 250 prenotices of noncompliance each year (as of March 2024, it had issued only 149 since 2013[6]).
A year later the FDA responded to the petition, granting some of the requests and denying others.[7] The agency denied a request to increase its enforcement efforts, partially granted a request to consider a new framework to prioritize its enforcement activities and granted a request to establish a public dashboard of prenotice letters of noncompliance. The FDA has launched the public dashboard of prenotice letters and will update the dashboard quarterly.[8] The prenotice letters request that the responsible party for the trial correct any potential violations within 30 days of receiving the letter. Examples of potential violations are failing to register an applicable clinical trial, failing to submit required information about the trial or submitting false or misleading information.
The good news in the FDA’s response is the statements that it “takes seriously its role in enforcing the ClinicalTrials.gov registration and results information submission requirements” and that these requirements “are important to our mission of protecting and promoting the public health.”[9] These words, however, will mean little unless there is greater compliance with the law.
The bad news is that the FDA continues to emphasize voluntary compliance. According to the agency’s response, “As in all areas that FDA regulates, the Agency’s goal is to achieve timely voluntary compliance with the law without having to resort to legal action, which can be resource intensive and time-consuming.”[10] Time will tell whether voluntary compliance coupled with increased public awareness of the FDA’s efforts will be sufficient to improve the registration and results reporting of clinical trials. I am very skeptical. Since 2017, voluntary compliance has repeatedly fallen short. Another citizen petition to increase enforcement may eventually be necessary.
References
[1] Ramachandran R, Morten CJ, Ross, JS. Strengthening the FDA’s enforcement of ClinicalTrials.gov reporting requirements. JAMA. 2021;326(21):2131-2132. doi:10.1001/jama.2021.19773.
[2] FDAAA Trials Tracker. https://fdaaa.trialstracker.net Accessed April 21, 2024.
[3] Food and Drug Administration. ClinicalTrials.gov – notices of noncompliance and civil money penalty actions. https://www.fda.gov/science-research/fdas-role-clinicaltrialsgov-information/clinicaltrialsgov-notices-noncompliance-and-civil-money-penalty-actions. Accessed April 21, 2024.
[4] Enforcing reporting requirements for clinical trials. Worst Pills, Best Pills News. 29(12): December 2023.
[5] Citizens Petition from Morningside Heights Legal Services, Inc. (on behalf of Universities Allied for Essential Medicines North America) to the Food & Drug Administration for increased enforcement of the ClinicalTrials.gov reporting requirements in the Food and Drug Administration Amendments Act of 2007. February 27, 2023. https://www.regulations.gov/document/FDA-2023-P-0660-0001. Accessed April 21, 2024.
[6] Food and Drug Administration. Pre-notices for potential noncompliance. https://www.fda.gov/science-research/fdas-role-clinicaltrialsgov-information/pre-notices-potential-noncompliance#:~:text=A%20Pre%2DNotice%20informs%20a,days%20after%20receiving%20the%20letter. Accessed April 21, 2024.
[7] Response Letter from FDA OC to Morningside Heights Legal Services, Inc. (on behalf of Universities Allied for Essential Medicines North America). February 21, 2024. https://www.regulations.gov/document/FDA-2023-P-0660-0019. Accessed April 21, 2024.
[8] Food and Drug Administration. Pre-notices for potential noncompliance. https://www.fda.gov/science-research/fdas-role-clinicaltrialsgov-information/pre-notices-potential-noncompliance#:~:text=A%20Pre%2DNotice%20informs%20a,days%20after%20receiving%20the%20letter. Accessed April 21, 2024.
[9] Response Letter from FDA OC to Morningside Heights Legal Services, Inc. (on behalf of Universities Allied for Essential Medicines North America). February 21, 2024. https://www.regulations.gov/document/FDA-2023-P-0660-0019. Accessed April 21, 2024.
[10] Ibid.
