Student-Led Nonprofit Petitions FDA to Strengthen Trial Reporting Enforcement
An international group of university students devoted to advancing health equity and access to therapies has filed a citizen’s petition urging for heightened efforts to improve compliance with trial reporting requirements, yet another call for the FDA to step up enforcement in this area.
Compliance “is hugely deficient … because FDA’s enforcement has been minimal and unfocused,” Universities Allied for Essential Medicines’ (UAEM) North American branch alleged in its citizen’s petition to FDA Commissioner Robert Califf following a prior letter to Califf and email exchange with the agency that it felt did not result in satisfactory responses.
UAEM believes the agency should take a number of specific actions to put greater pressure on adhering to reporting requirements, including dramatically increasing the number of preliminary notices of noncompliance it issues yearly, sending more notices of noncompliance to sponsors who fail to react to preliminary notices and imposing civil penalties when all else fails with sponsors. To date, the FDA has not yet issued a single fine for continued noncompliance, a common criticism from groups calling for greater trial transparency.
Second, UAEM believes it’s time for the FDA to issue new guidance that clearly spells out a more focused agency approach to enforcing trial reporting compliance. The guidance should include a “prioritization framework” that takes limited agency resources into account by focusing on the most important trials and findings, the petition reads. UAEM believes the agency should first focus on NIH-funded trials (trials receiving intramural or extramural funding from the NIH, including all trials sponsored by NIH and its grantees).
Finally, the nonprofit requests that the agency create a public dashboard of preliminary notices, which may increase the effectiveness of the agency’s enforcement actions. The FDA website currently lists notices of noncompliance and civil money penalties but does not publish information about when and to whom it sends notices.
“Enforcement actions have been scattered, unpredictable and unfocused even though pre-notices and notices of noncompliance have been effective when issued,” they wrote. “The status quo — minimal enforcement action from FDA — fails to fulfill FDA’s administrative duty. Permitting responsible parties to evade compliance with … federal law without tangible consequences sets a dangerous precedent with import far beyond the context of clinical trial data reporting.”
Read the full citizen petition here: https://bit.ly/3EJScNd.