Drugs

Judge Orders Old Clinical Trial Info Posted

A New York federal judge has ruled that data from clinical trials conducted for not-yet-approved drugs and medical devices over a 10-year period between 2007 and 2017 must be published online at ClinicalTrials.gov. The ruling comes in a 2018 suit against HHS, FDA, and the National Institutes of Health brought by former FDA associate commissioner Peter Lurie, now president of the Center for Science in the Public Interest, and New York University journalism professor Charles Seife.

The two said their suit was intended to force the agencies to overturn a rule purporting to relieve researchers of their obligation to report basic results information for certain clinical trials involving human subjects. “Comprehensive reporting of this data serves to promote the integrity of clinical research, improves the quality of decisions made by clinicians and policymakers, reduces bias in scientific literature, and informs patients, clinicians, and regulators about intervention safety and effectiveness,” the court filing said.

The court held that the FDA Amendments Act of 2007 unambiguously requires that the specific trial results challenged in the suit be filed at ClinicalTrials.gov. “Thus,” the decision says, “HHS’ contrary interpretation, which the agency announced in the preamble of the final rule, is unlawful and must be set aside.”

In a statement on the ruling quoted in a STAT online article, Seife said, “FDA is in charge of making sure that drugs on the market are safe and effective, but without access to data about those drugs, it’s nearly impossible to understand whether the agency is doing its job properly.”

An HHS spokesperson told STAT the agency was “evaluating the court’s decision with the Department of Justice to determine our next steps.” An FDA spokesperson declined to comment.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome