New York University Law Clinic (aka Washington Square Legal Services, Inc.) and Yale University Media Freedom and Information Access Clinic
37,500.00
Court
Null
Plaintiffs Charles Seife and Peter Lurie sued HHS, the Secretary, NIH, the Director, FDA, and the Commissioner, challenging an interpretation of FDAAA set forth in the Final Rule that basic results summary information did not need to be submitted to the ClinicalTrials.gov data bank for any ACT completed before the Final Rule’s effective date if the ACT studied a product that was approved by FDA after the ACT was completed. Plaintiffs also claimed that NIH failed to post notices regarding noncompliance and make them searchable in the ClinicalTrials.gov data bank. The court granted Plaintiffs’ motion for summary judgment on the statutory interpretation issue and granted Defendants’ motion to dismiss and/or for summary judgment on the last two issues.
The court held that, the Food and Drug Administration Amendments Act of 2007 (FDAAA) unambiguously requires responsible parties to submit to the ClinicalTrials.gov data bank summary basic results information for applicable clinical trials (ACTs) completed before January 18, 2017, if the ACT studies a product that is approved, licensed, or cleared by FDA at any time, including after the ACT’s primary completion date.