On September 21st, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document titled “Civil Money Penalties Related to the ClinicalTrials.gov Data Bank” (“Draft Guidance”) regarding the imposition of civil money penalties (“CMPs”) for failure to submit required clinical trial information to ClinicalTrials.gov or improperly certifying compliance with the FDA’s clinical trial information submission requirements in certain applications and submissions to the FDA.

The CMPs would enforce Section 402(j) of the Public Health Service Act (codified at 42 U.S.C. 282(j)) and its implementing regulations at 42 CFR Part 11 (hereinafter referred to collectively as “Section 402(j)”), which requires responsible parties, including sponsors and principal investigators in limited circumstances, to register applicable drug, biologics, and device trials on, and submit summary results data from such trials to, ClinicalTrials.gov. In addition, Section 402(j) requires submitters of certain applications and submissions to the FDA (e.g., new drug and biologics licensing applications and pre-market approvals, among others) to certify compliance with Section 402(j).

According to the Draft Guidance, the FDA will detect non-compliance with clinical trial information reporting and certification requirements through its inspection and investigation activities in connection with the Bioresearch Monitoring Program (“BIMO”). The FDA intends to focus on:

  • Failure to register higher risk applicable clinical trials or applicable clinical trials of public health importance;
  • Responsible parties or submitters who have a pattern of noncompliance with the reporting and certification requirements under Section 402(j); and
  • Applicable clinical trials for which noncompliance with Section 402(j) exists in conjunction with potential violations of other clinical trial regulations.

As described in the Draft Guidance, the investigation and enforcement process would include:

  • Receipt of a Preliminary Notice (“Pre-Notice”) of Noncompliance Letter from the FDA upon the agency’s discovery of potential non-compliance;
  • Receipt of a Notice of Noncompliance if, after 30 days from receipt of a Pre-Notice Letter, the FDA finds any non-compliance with Section 402(j) upon investigation of the responsible party’s or submitter’s applicable ClinicalTrials.gov entries and/or applications and submissions in the FDA’s files; and
  • Commencement of the CMP process, taking into account the type of noncompliance and any circumstances associated with a lack of remediation, if the responsible party or submitter does not rectify the non-compliance within 30 days after receiving the Notice of Noncompliance.

A responsible party or submitter who is facing the imposition of CMPs can pay the CMP or submit an answer to the FDA’s complaint and obtain a hearing or enter into settlement discussions with the FDA. The FDA has the authority to impose CMPs of up to $11,569 for all violations of Section 402(j) adjudicated in a single proceeding. In addition, if a violation is not corrected by the responsible party or submitter within 30 days of receiving notice of the violation, the FDA may impose a CMP of up to $11,569 for each day the violation goes unresolved.

The Draft Guidance is currently open for public comment until November 20, 2018. Comments may be submitted through the applicable docket page at www.regulations.gov.

Posted by Cooley