February 2020: United States Update

Court’s Ruling Requires Government to Post A Decade’s Worth of Clinical Trial Results

As per the news published on YLS Today on February 25, 2020, a ruling from a federal judge will dramatically expand the public’s right to access results of clinical trials studying drugs and medical devices.

Judge Naomi Reice Buchwald of the Southern District of New York held that the Food and Drug Administration (FDA), National Institutes of Health (NIH), and Department of Health and Human Services (HHS) have misinterpreted a 2007 law that requires drug companies, universities, and other sponsors of clinical trials to disclose the results of clinical trials of FDA-approved products to the public via the ClinicalTrials.gov website. The court’s order requires the government to collect and post about a decade’s worth of trial results that should be public under the 2007 law — making data from potentially hundreds of clinical trials available for the first time.

The court concluded that the FDAAA unambiguously requires ClinicalTrials.gov to include, the results of the applicable clinical trials which were completed before the Final Rule’s effective date of January 18, 2017 and studied a product that the FDA approved after the applicable clinical trial’s completion.

However, the FDA has not commented on the above yet and thus, how and when the data will be published is still undecided.



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