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# HHS Sued Over Trial Reporting Rule
- URL: https://www.fdaweb.com/hhs-sued-over-trial-reporting-rule/
- Published: 2018-12-11T12:00:00.000Z
- Updated: 2026-09-15T00:50:07.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5143010

Former FDA associate commissioner **Peter Lurie**, now president of the Center for Science in the Public Interest, and New York University journalism professor **Charles Seife** are suing HHS, FDA, and the National Institutes of Health in an effort to overturn their rule purporting to relieve medical researchers of their legal obligation to report basic results information for certain clinical trials involving human subjects. The [suit](http://www.fdaweb.com/download.php?file=seife-lurie%5FClinTrials-Co.pl%5Faint.pdf), filed in a New York federal court, also wants to compel the three agencies to post public notices (of corporate noncompliance) that are mandated by law “but which have been unlawfully withheld and/or unreasonably delayed.”

The suit notes that clinical trial data regarding medications, medical devices, and medical treatments provide a crucial resource for clinicians, patients, researchers, policymakers, and the general public. “Comprehensive reporting of this data serves to promote the integrity of clinical research, improves the quality of decisions made by clinicians and policymakers, reduces bias in scientific literature, and informs patients, clinicians, and regulators about intervention safety and effectiveness,” it says.

The filing reviews Congress’ requirements for reporting at ClinicalTrials.gov and says that in 2016, nine years after Congress imposed the requirements, the agencies “promulgated a final rule that contravenes the clear statutory mandates. The final rule purports to relieve parties responsible for clinical trials completed before 1/18/17 from disclosing the basic trial results for studies of drugs or devices that were unapproved as of the trial’s primary completion date, but which were subsequently approved. Moreover, there has been, and continues to be, a widespread and well-documented failure by responsible parties to comply with their statutory reporting obligations over the last 11 years. Defendants have nevertheless failed to post even a single statutorily required notice of noncompliance on ClinicalTrials.gov, and they have failed to create a mechanism by which the public can search for instances of noncompliance.”

The suit seeks an order **(1)** striking down those portions of the final rule purporting to relieve responsible parties of their statutory obligation to report basic results for pre-final rule clinical trials for unapproved drugs or devices that were subsequently approved; and **(2)** compelling the agencies to issue noncompliance notices for any clinical trial where the responsible party has failed to satisfy its statutory reporting obligations and to make those notices easily searchable on ClinicalTrials.gov.