A judge has ruled in favor of plaintiffs seeking to broaden access to federal clinical trial information, helping close a long-standing loophole.
In Seife & Lurie v. U.S. Department of Health and Human Services et al., a Southern District of New York judge has decreed that the Food and Drug Administration (FDA), National Institutes of Health (NIH), and Department of Health and Human Services (HHS) misconstrued a 2007 law. The law in question requires drug companies, universities and other clinical trial sponsors to disclose the results of trials involving FDA-approved products, via the ClinicalTrials.gov website.
The order requires federal agencies to post approximately a decade's worth of trial results that should have been made public under the FDA Amendments Act (FDAAA), signed by President George W. Bush in 2007. However, interpretations by different agencies created a “loophole” through which a number of trials were considered exempt. The motion means that unreleased data from hundreds of clinical trials will be made available to the public for the first time.
The lawsuit was filed on behalf of Peter Lurie, president of the Center for Science in the Public Interest (CPSI), and New York University journalism professor Charles Seife. The two gentlemen allege their research into clinical trials has been hindered by the lack of openness.
The suit was brought by Yale Media Freedom and Information Access (MFIA), a student group dedicated to increasing government transparency and championing the public right to information access; and NYU Technology Law & Policy (TLP) Clinic, another student group focusing on technology, law, and social justice. The litigation effort also is supported by the Yale Collaboration for Research Integrity and Transparency (CRIT).
Lurie told Outsourcing-Pharma that the ruling will lead to greater openness about clinical trial and government approval of therapies.
“This data, when posted, will allow us to shine a better light on the FDA approval process,” Lurie said. He added that people interested in learning about a particular drug or trial will be able to access information previously not available to them.
In 2004, members of Congress expressed concern about the safety and effectiveness of products that had been approved by the FDA, but for which unfavorable clinical trial results had not been publicly disclosed. They also expressed displeasure at ClinicalTrials.gov hosting information only for serious or life-threatening diseases, believing it should be broadened to less-serious conditions.
This discussion about clinical trial data led to Congress enacting the FDAAA. According to Christopher Morten, supervising attorney at the TLP Clinic, the intent of the legislation was “to ensure a flow of clinical trial evidence to patients, clinicians, and researchers through the public ClinicalTrials.gov website.” Unfortunately, he added, it didn’t work out that way.
“NIH and HHS promulgated a rule and an interpretation of FDAAA that created an illegal ‘loophole,’” Morten said.
As MFIA student Simon Brewer explained, “The loophole purported to exempt many clinical trials of FDA-approved products completed between 2007 and 2017 from any obligation to ever report their results to ClinicalTrials.gov.”
As a result of the ruling, agencies must post clinical trial results on ClinicalTrials.gov, Lurie said, unless they appeal and win their decision.