Home Clinical Trial Data Transparency FDA & NIH Not Following Established Law According to Filed Lawsuit

FDA & NIH Not Following Established Law According to Filed Lawsuit

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As filed with legal website PacerMonitor plaintiffs have sued the U.S. Food and Drug Administration as well as the National Institutes of Health and Health and Human Services alleging that the agencies have relaxed reporting requirements. TrialSite News provides a summary:

Plaintiff(s):

Peter Lurie, an ex-associate commissioner for public health strategy and analysis with FDA

Charles Seife, New York University journalism professor

Key Issue

The plaintiffs have alleged that the executive branch agencies have ignored a federal law requiring that drug sponsors file clinical data with the federal government for public transparency.

In 2007, Congress created law that required sponsors working on certain drug and device trails to report the results to the three government agencies. In certain circumstances, the data needed to be reported within 30 days of FDA approval. Thereafter, the data was to be posted on government-sponsored website Clinicaltrials.gov.

The plaintiffs allege that many years after the legal requirements were established, the defendants publicized a rule that “contravenes the clear statutory disclosure mandates.” It was reported by Law360 that the plaintiffs positioned that trials falling into an exempt category (for purposes of reporting requirements) are those “with a primary completion date before Jan. 18, 2017 if the drug being studied wasn’t approved until that date.”  It is alleged that the agencies have continued to fall far short of their legal obligations to comply statutory reporting requirements for the past several years. At the crux of the plaintiff’s argument is that the reporting deficiencies “deprives plaintiffs and other members of the public of the data necessary to ensure transparency in research, promote better decision-making by clinicians and policy makers, eliminate bias in the medical literature and inform patients, clinicians and regulators about medical product safety and effectiveness.” The plaintiffs ultimately seek a ruling to remove sections of the 2017 ruling which they claim relieves “responsible parties of their statutory obligation to report basic rules for pre-final rule clinical trials for unapproved drugs or devices that were subsequently approved.”

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