Tuesday, October 30, 2018


CRIT Submits Comments on FDA's Draft Guidance, Calls for Stronger Procedures

On September 21, 2018, the Food & Drug Administration (FDA) released draft guidance on civil penalties relating to the ClinicalTrials.gov database. The guidance describes FDA’s proposed procedures for imposing penalties when parties responsible for reporting the results of clinical trials for drugs and medical devices fail to do so. On October 30, 2018, Yale’s Collaboration for Research Integrity and Transparency (CRIT) submitted public comments on the draft guidance, explaining that the procedures described in the draft guidance are inadequate and urging the FDA to revise the guidance to strengthen its procedures.  

The Food and Drug Administration Amendments Act (FDAAA), enacted in 2007, mandates that parties responsible for certain applicable clinical trials of drugs and medical devices register those trials on ClinicalTrials.gov. FDAAA further requires that the responsible parties report results of those trials within specified time periods, so that the public may access the results on ClinicalTrials.gov. FDAAA created a system of mandatory oversight, directing FDA, along with the National Institutes of Health (NIH) and the Department of Health and Human Services (HHS), to monitor, verify, and enforce compliance with responsible parties’ registration and reporting requirements.  

Although FDAAA was enacted in 2007, the September 21 draft guidance titled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank,” constitutes FDA’s first and (to date) only guidance document detailing how it plans to enforce compliance. The guidelines set forth FDA’s first proposed procedures both to identify noncompliance by responsible parties—for example, failure to register covered applicable clinical trials or failure to report the results of those trials—and to penalize such noncompliance. While failure to report the results of clinical trials, as required by FDAAA, is widespread, FDA has never—in the eleven years since Congress enacted the reporting requirement—imposed a monetary penalty for failure to report.

CRIT’s public comments identify numerous deficiencies in the draft guidance, including ways in which the procedures outlined in the draft guidance fail to meet the monitoring and enforcement obligations imposed on FDA and NIH by FDAAA.  CRIT’s comments suggest revisions to align FDA’s procedures with these obligations. “While we are pleased that FDA is developing a plan to monitor and enforce the statutory reporting requirements for clinical trials, FDA and NIH must do more,” said Margaret E. McCarthy, Executive Director of CRIT. “FDA and NIH must themselves comply with the enforcement mandate of FDAAA.”  

CRIT encourages other organizations and individuals interested in promoting transparency in drug and medical device research to submit comments of their own on FDA’s draft guidance.  Comments are due by November 20, 2018.

The Collaboration for Research Integrity and Transparency (CRIT) is an inter-disciplinary initiative launched in 2016 at Yale Law School, Yale School of Medicine, and Yale School of Public Health, whose mission is to promote health by improving the integrity and transparency of biomedical and clinical research. A recent CRIT white paper explains the importance of transparency in clinical research.