FDA's White Oak Building

FDA releases their first public Notice of Noncompliance to a Principal Investigator

Posted by the UW Clinical Research Office CT.gov Service Team

In 2007, President George W Bush signed into law the Food and Drug Administration Amendments Act (FDAAA) requiring Applicable Clinical Trials (ACTs) to be registered to ClinicalTrials.gov (CT.gov) within 21 days of the first participant enrolled and for those same trials to report summary results to CT.gov within 1 year of the Primary Completion Date (date upon which data collection is completion to answer the primary outcome). ACTs are Interventional, Phase 2-4 clinical trials that study the effect of an FDA-Regulated Drug, Device, or Biologic on participant health outcomes.

 FDAAA Law further defines the consequence of noncompliance: civil monetary penalties up to $10,000 per day (2021 adjustment for inflation at $12,462), loss of HHS funding, FDA sanctions (483 letter), and public notice of noncompliance.

 Due to a lack of enforcement, by 2015 only 20% of clinical trials registered to CT.gov within the scope of FDAAA Law were compliant with the law. Clinical trials transparency advocates at Oxford established the FDAAA Trials Tracker to name noncompliant trial records and those Responsible Parties and to keep track of fines claimed by the US Government ($0 of the potential $26 billion as of this writing – Dec 2021).

 Since FDAAA 801 and the Final Rule went into effect on January 18, 2017, there has been a growing chorus from clinical trials advocacy groups for the FDA to make good on its threats. Articles calling out noncompliance spread like wildfire (STAT News). There was suddenly a sense of urgency around bringing public clinical trials records into compliance.

 It was in this environment that the central UW CT.gov Service Line was established with a two-fold goal: to bring UW CT.gov records into compliance and to develop processes for maintaining compliance going forward. As of 2020, these goals were met.

 This was good timing as the first 3 FDA Notices of Noncompliance were sent out in 2021, 2 were for Industry records, and in August of this year, the first notice was sent out to a Principal Investigator at an Academic Medical Center.

 This public notice informs us of the communications between the PI and the FDA, dated July 20, 2020. Notably, the PI had attempted to satisfy the results reporting requirement by submitting their manuscript (which does not meet the legal requirement of populating the Results Module) and to rationalize noncompliance with pandemic-related delays. The FDA simply returned, “Although we recognize the unique circumstances that the pandemic presents, we believe we have provided you ample opportunity to submit the required results information”.

 The UW CT.gov Service Line is uniquely positioned to assist PIs in CT.gov compliance, is active in a national CT.gov Taskforce to keep on top of ever changing requirements and to learn from the experience of other Institutions, and is invested in the mission of clinical trials transparency advocates. They have also created an Investigator Guidance to CT.gov resource for your team.

Please feel free to contact them with any questions, CT.gov support needs, or to request an Introduction to CT.gov for your department or research group.