An organization that promotes and studies clinical trial disclosure has petitioned the Food and Drug Administration to take several steps to boost its enforcement of wayward trial sponsors and investigators that fail to register studies and report results.
In arguing its case, the Universities Allied for Essential Medicines maintained the FDA has done such a poor job of enforcing the law that a lack of compliance “remains widespread” and potentially life-saving data have been kept from the public. The problem threatens “the health and informational rights of particularly vulnerable patients, including children,” the group wrote in its petition.
The organization cited numerous studies that have found the regulator has failed to adequately follow up with clinical trial sponsors and investigators, even though the FDA has enforcement tools at its disposable. Moreover, UAEM noted the regulator has never used its enforcement power to levy civil fines against sponsors that fail to register their studies at ClinicalTrials.gov, a federal database, or report results.
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