On March 9th, the law firms Hyman, Phelps & McNamara and Ropes & Gray posted legal ‘perspectives’ regarding the February 24th federal court ruling (Seife decision) regarding reporting clinical trial results for clinical trials conducted between 2007 and 2017 on ClinicalTrials.gov. Below is a summary of the two postings:
Since clinical trial registration and results information was first required to be reported to ClinicalTrials.gov, few issues have been more confusing than whether and what type of clinical trial results must be reported for Applicable Clinical Trials (ACTs) completed before the studied product was approved for marketing. For nearly ten years, the interpretation by the Department of Health and Human Services (HHS) of the Food and Drug Administration Amendments Act (FDAAA) results requirements made it seem that Responsible Parties need not report Basic Results for pre-Rule, pre-approval ACTs. The Seife decision has upended that understanding.
If the US government allows the ruling to take effect without appealing, or if it is upheld on appeal, this decision could prove onerous for study sponsors who have relied on this exemption in the National Institutes of Health (NIH) regulations. There is now a substantial amount of data—nearly ten years’ worth of clinical trial results for products that had not received marketing authorization at the time of trial completion—that may ultimately need to be submitted to ClinicalTrials.gov.
- Issue 1: HHS’s Interpretation of Final Rule Implementing FDAAA
The Court found that the FDAAA unambiguously requires Responsible Parties to submit, and to include on ClinicalTrials.gov, Basic Results for pre-Rule, pre-approval ACTs. Judge Buchwald compared the text of FDAAA and HHS’s Final Rule relating to the reporting of Basic Results and found that the Final Rule language is virtually identical to FDAAA. Because the Court found that FDAAA unambiguously requires Responsible Parties to submit, and the government to include on ClinicalTrials.gov, Basic Results for pre-Rule, pre-approval ACTs, the Court granted plaintiff’s motion for summary judgment to hold unlawful and set aside HHS’s interpretation of the Final Rule as contrary to the FDAAA.
- Issue 2: FDA’s and NIH’s Failure to Engage in Enforcement Action
FDAAA also created enforcement mechanisms to ensure that responsible parties comply with their clinical trial reporting obligations. HHS was empowered to issue a notice of noncompliance to a Responsible Party that fails to submit or submits false or misleading clinical trial information. To date, FDA has never issued a noncompliance notice under its authority, and NIH has neither posted a public notice of noncompliance nor created a search function for such notices on ClinicalTrials.gov. Requiring NIH to post noncompliance notices on ClinicalTrials.gov without FDA first issuing their noncompliance notice to the responsible party would be “nonsensical” according to Judge Buchwald. Similarly, NIH’s nondiscretionary obligation to create a search function is predicated on FDA’s discretionary obligation to issue noncompliance notices to responsible parties for failing to submit clinical trials data. NIH is not required to create a search function for FDA noncompliance notices that do not exist.
While the court’s decision requires the results of clinical trials conducted in unapproved products between September 2007 and January 2017 to be posted on ClinicalTrials.gov, it is unclear whether FDA will require Responsible Parties to report, how long responsible parties have to report, and for HHS to subsequently post, such data. HHS has not announced whether it will appeal the Seife decision, nor has it offered any reporting guidance in light of the decision. Given the competing priorities at HHS, and the historical lack of enforcement related to ClinicalTrials.gov, it remains to be seen whether and how HHS will take any action to require reporting in line with the court’s decision. For now, Responsible Parties should recognize that Basic Results for Pre-Rule ACTs of products that were not yet approved or cleared at the time of completion of the trial may need to be reported in the future. In the meantime, it would be prudent for Responsible Parties to take an inventory of clinical trials potentially impacted by the Seife decision so that Basic Results reporting, if ultimately required, could begin without significant delay.