Earlier this year, we wrote about a ruling by the U.S. District Court for the Southern District of New York that, if upheld, would require companies to make public a decade of clinical trial results for products that have been approved by the Food and Drug Administration (FDA). In a surprising move, the Department of Health and Human Services (HHS) has now signaled it does not intend to appeal the ruling, and has made changes to the results submission requirements of ClinicalTrials.gov in accord with the District Court’s decision. There has been relatively little fanfare surrounding these changes given their significance – to date, no notice in the Federal Register has been published announcing the adoption of these new requirements by HHS. Rather, HHS has quietly updated the FAQ section of ClinicalTrials.gov to describe the new results submission requirements.
Under the new results submission requirements, responsible parties are required to submit results information for applicable clinical trials (ACTs) meeting the following criteria:
The ACT was initiated after September 27, 2007, or was ongoing as of December 26, 2007;
The ACT reached its primary completion date before January 18, 2017; and
The ACT studied a product that is approved, licensed, or cleared by FDA at any time, including after the ACT’s primary completion date.
Prior to the District Court decision, HHS did not require the submission of results for ACTs meeting the first two criteria above, so long as the product being studied was not approved as of the primary completion date. This was the case even if FDA approved the product at a later date. Following the District Court decision, HHS now requires the submission of results information for an ACT meeting the first two criteria if FDA approves the product on or after the primary completion date. The deadline for the submission of results for these ACTs is 30 days after the date that the product is approved by FDA. For ACTs where the results submission deadline has already passed, HHS states in the ClinicalTrials.gov FAQ that the results information should be submitted “as soon as possible.”
We note that because the ACTs subject to the new results submission requirements have primary completion dates before Jan. 18, 2017, the responsible parties for these ACTs need submit the “basic results” required by the statute under the Public Health Service Act, and not the expanded results information specified under the regulations at 42 CFR 11.48. This means that responsible parties do not have to submit certain results information that would otherwise be required if the primary completion date was on or after Jan. 18, 2017. For example, the protocol and statistical analysis plan for these ACTs do not have to be submitted.
The degree to which FDA will enforce the new results submission requirements remains to be seen. However, we are aware of sponsors receiving emails from ClinicalTrials.gov (run by the National Institutes of Health) identifying specific clinical trial listings that may now require results to be submitted following the District Court decision. In light of these developments, companies should review their listings on ClinicalTrials.gov to determine whether any of their studies are subject to the new results submission requirements. Hogan Lovells will continue to monitor this situation for updates.