graphic of pen pointing at data chart

Seife v. HHS: A Decade of Missing Trial Data

By Phebe Hong

Data is knowledge, and knowledge is power. Thanks to a recent court ruling, more medical data may soon be available to the public. A Southern District New York federal judge ruled this week that the FDA and NIH had been misinterpreting a law requiring clinical trial sponsors to release data. The ruling clarifies that reporting requirements – previously applied only to trials completed after 2017 – actually applies to trials completed since 2007. As a result, many pharmaceutical companies, biotechs, universities, and other institutions will have to provide previously unpublished data (or risk non-compliance).

The ruling of Seife v. HHS has been broadly summarized by STAT, Endpoint News, and Science Magazine. Here, we take a closer detailed look at the court’s legal opinion and reasoning:

Legal Background:

  • FDAAA: The Food and Drug Administration Amendments Act of 2007 requires parties to publish trial results on ClinicalTrials.gov. Both types of trial data results – “Basic Results” and “Expanded Results” – are required for approved drugs.
  • Final Rule: An HHS regulation issued in 2016 interpreting the statute exempted many clinical trials completed between 2007 and 2017 from any obligation to report results.

Procedural History: In December 2018, plaintiffs Charles Seife (science journalist) and Peter Lurie (former FDA Associate Commissioner) filed a complaint against the HHS, the FDA, and the NIH. Plaintiffs’ primary cause of action alleges that HHS’s interpretation of the Final Rule is contrary to the unambiguous terms of the FDAAA. Both parties moved for summary judgment.

Holding: The court granted the plaintiffs’ motion for summary judgment in part, holding that the FDAA unambiguously requires sponsors to submit all trial data of approved products, including data from 2007 to 2017 (setting aside HHS’s Final Rule interpretation).

Rationale:

  • The Court rejected the use of Auer, Chevron, and Skidmore deference analyses, finding that HHS’s Final Rule simply “restate[s] the terms of the statute itself.” The statute, the court determined, unambiguously requires parties to report results for products presently approved by the FDA.
  • The Court used plain language and contextual analysis to reach this determination, in addition to the FDAAA’s overall purpose to “help patients, providers, and researchers learn new information and make more informed healthcare decisions” by “increas[ing] the availability of information to the public.”
  • The Court rejected the defendants’ argument that the statute should not be applied retroactively, stating that the defendants “created the retroactivity concern about which they complain.”

It is unclear if the HHS will appeal the court’s decision. Even if they do not, it is still unclear how the agencies will enforce the regulations to compel actors to publish a decade’s worth of missing data. Regardless, this week’s ruling should be considered a win for patients, doctors, and researchers who will potentially benefit from the increased access to powerful and important trial data.

Phebe Hong

Phebe Hong

Phebe Hong is a 2L at Harvard Law School. She graduated from Harvard College with a degree in Human Developmental and Regenerative Biology. Prior to law school, she worked as a consultant advising pharmaceutical and biotechnology companies. She is a Research Assistant at the Program on Regulation, Therapeutics, and Law (PORTAL) and an Articles Editor for the Journal of Law and Technology. Her research interests include FDA regulation of biologics and pharmaceutical patent law.

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