Drugs

Mend Lax Clinical Trial Reporting: Pallone

House Energy and Commerce Committee ranking member Frank Pallone (D-NJ) has written to FDA and the National Institutes of Health (NIH) with a concern about the “lack of compliance by medical product sponsors with requirements to report certain clinical trial results information to the ClinicalTrials.gov database.” His 1/19 letter cites a recent study indicating that sponsors of 31% of registered trials required to report results have failed to report any results, and another 30% 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.

Pallone says that both FDA and NIH have a role in enforcing 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, he says. And FDA is responsible for enforcement and has the authority to pursue civil monetary penalties, injunctions, or criminal prosecution for noncompliance. Recent studies show that when the agencies take action, he says, clinical trial sponsors quickly comply with requirements. However, according to Pallone, FDA and NIH have rarely taken action to enforce clinical trial reporting requirements and many trials remain out of compliance.

“FDA has not yet imposed any civil money penalties on any trial sponsors,” Pallone writes. “The collection of these penalties would provide a stronger incentive for trial sponsors to comply.”

He asks for this information from the two agencies:

the number of pre-notices and notices of noncompliance that FDA has sent;
for NIH-funded trials, the number of compliance and enforcement actions taken concerning responsible parties that do not comply with ClinicalTrials.gov requirements;
how FDA most commonly assesses compliance;
how FDA compliance and enforcement actions have been aligned with prioritization based on product risk, public health need, compliance history, and whether there are additional violations of clinical investigation requirements; and
whether FDA has approved or cleared premarket submissions without the certification of ClinicalTrials.gov compliance required by law and the basis for such an action.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome