Lawsuit Charges FDA, NIH With Failing to Follow Established Law for Reporting of Clinical Trial Data

FDA sign outside office building

A lawsuit filed by a former official with the U.S. Food and Drug Administration (FDA) alleges in a lawsuit that the regulatory agency has relaxed reporting requirements for clinical trials.

Last week Peter Lurie, an ex-associate commissioner for public health strategy and analysis at the FDA, filed a lawsuit in New York federal court against the regulatory agency, the National Institutes of Health (NIH) and the U.S. Department of Health and Human Services. The lawsuit charges that the government agencies have ignored a federal law requiring that researchers file clinical data with the federal government. In the lawsuit, Lurie and New York University journalism professor Charles Seife, allege that the reporting rules do not comply with the Food and Drug Administration Amendments Act as it “purports to exempt certain trials from the registration and reporting requirements,” Law360 reported.

Click here to get clinical trial highlights straight to your inbox. Subscribe now to the ClinicaSpace newsletter

In the lawsuit, the plaintiffs said that in 2007 Congress required researchers who were working on certain trials for drugs and medical devices to report the results to the three government agencies. If the device wasn’t approved at the time the trials were completed, but later approved, there are requirements that the data be reported within 30 days of approval. The data was to be posted on

The complaint said that in 2016, nine years after the requirements were first put into place, the three government agencies publicized a rule that “contravenes the clear statutory disclosure mandates.” The plaintiffs argue that trials that are exempt from the new reporting requirements are those “with a primary completion date before Jan. 18, 2017 if the drug or device being studied wasn’t approved until after that date,” Law360 reported.

The plaintiffs go on to say in the complaint that there “has been, and continues to be, widespread and well-documented failure… to comply with their statutory reporting obligations over the last eleven years.” The plaintiffs argue that the failure to issue notices of noncompliance with transparency rules “deprives plaintiffs and other members of the public of the data necessary to ensure transparency in research, promote better decision-making by clinicians and policymakers, eliminate bias in the medical literature, and inform patients, clinicians and regulators about medical product safety and effectiveness.”

By filing the lawsuit, the plaintiffs said they are seeking an order to strike down the portions of the ruling regarding the 2017 date, which they said 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.”

“Defendants have nevertheless failed to post even a single statutorily required notice of noncompliance on, and they have failed to create a mechanism by which the public can search for instances of noncompliance,” the lawsuit said.

The lawsuit was filed two months after the FDA abandoned a proposal to force drug and medical device makers to disclose data manipulation in clinical trials, according to the Law360 report.

Back to news