Ruling In HHS Case May Mean More Drug Trial Reporting

By Christina Markus, Beverly Lorell, Ashley Parrish, Elaine Tseng and Jeffrey Bucholtz (March 19, 2020, 5:25 PM EDT) -- Section 801 of the U.S. Food and Drug Administration Amendments Act of 2007 (codified at 42 U.S.C. § 282(j)) requires that sponsors of applicable clinical trials, or ACTs, register those trials and submit "basic results" specified in the statute to the public data bank.

Although six years past its deadline, in September 2016 the U.S. Department of Health and Human Services promulgated regulations that took effect Jan. 18, 2017, and expanded the disclosure requirements — including now requiring results from ACTs involving never-approved drugs and medical devices to be disclosed publicly.

In the preamble of the rule, when discussing the...

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