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A Democratic lawmaker is demanding to know what steps the Food and Drug Administration and the National Institutes of Health are taking to ensure that results of clinical trials are reported to a federal database.

In a letter sent to the agencies, U.S. Rep. Frank Pallone (D-N.J.) cited a recent report showing the NIH has failed to conduct proper follow-up. Specifically, the agency failed to verify that half of 72 funded trials were reported in 2019 and 2020 to, according to the report, which was published by the Office of Inspector General for the Department of Health and Human Services.


At the same time, Pallone demanded to know what the FDA is doing to enforce requirements that trial results are reported. He noted the agency sent notices to a few companies and clinical trial investigators for failing to report results, but has addressed only a “tiny fraction” of the many thousands of instances in which there are outstanding violations.

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