A Win, a Draw and a Loss for More FDA Action on Trial Reporting Noncompliance

A student group that filed a citizen petition aimed at improving what it alleges are “hugely deficient” trial reporting enforcement efforts by the FDA has gained some ground in the ongoing effort to increase trial transparency, with the agency granting one of its requests and pledging to consider another.

Following multiple attempts to meet with agency leadership, Universities Allied for Essential Medicines North America (UAEM), a nonprofit group of U.S. and Canadian students that advocates for medical research and drug access, penned a citizen petition alleging that the agency’s efforts to enforce ClinicalTrials.gov reporting requirements have been vastly insufficient and unfocused.

The group filed the petition with support from Columbia Law School’s Science, Health and Information Clinic (SHIC) over a year ago, and made three requests of FDA Commissioner Robert Califf in its mission to improve trial transparency.

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