While the staff at the U.S. Department of Health and Human Services (HHS) is currently all hands-on-deck in responding to the COVID-19 outbreak, some of the agencies in the department may have to divert resources to get sponsors of drug and device clinical trials to fill in nearly a decade-long data gap on Clinicaltrials.gov. That’s if a judge’s decision handed down this week stands.

Under that order out of the U.S. District Court for the Southern District of New York, HHS must collect and post almost 10 years’ worth of trial results that should be public in accordance with the 2007 FDA Amendments Act (FDAAA), making data from potentially hundreds of clinical trials available for the first time. Those trials would have been completed between Sept. 27, 2007, and Jan. 18, 2017.

The gap stems from HHS’ delay in issuing a final rule to implement an FDAAA provision requiring basic data to be submitted to Clinicaltrials.gov for applicable clinical trials (ACTs) of drugs and devices, regardless of approval status.

When it finally got around to issuing the rule in the waning days of the Obama administration, HHS interpreted the rule as being effective for applicable trials completed on or after Jan. 18, 2017. The department got that wrong, U.S. District Judge Naomi Reice Buchwald said this week in Charles Seife v. HHS.

The department defended its interpretation, arguing against what it called a “retroactive” enforcement of the rule. The judge wasn’t swayed by that argument, especially since the rule parroted the FDAAA provision.

“Responsible parties knew since the FDAAA’s enactment in 2007 that the statute required them to submit basic results for each ACT of a product that is approved,” she said. “It was only when HHS promulgated the final rule nearly ten years after the FDAAA’s enactment and almost six years after the statutory deadline for doing so … that HHS definitively told responsible parties that they were not required to submit basic results for pre-rule, pre-approval ACTs. Defendants therefore created the retroactivity concern about which they complain.”

Reice Buchwald added that “‘no matter how it is framed, the question a court faces when confronted with an agency’s interpretation of a statute it administers is always, simply, whether the agency has stayed within the bounds of its statutory authority,’ and HHS has not.”

In finding that HHS’ interpretation of the final rule was contrary to the FDAAA, Reice Buchwald noted that Congress enacted the provision because it was concerned that trial sponsors might not release negative results, making it impossible for the public to assess the safety and efficacy of drugs and devices.

“Plainly, requiring Clinicaltrials.gov to include basic results for pre-rule, pre-approval ACTs ameliorates that concern and furthers those broader goals,” Reice Buchwald said. “Doing the opposite, by contrast, would exempt the responsible parties for every pre-approval ACT completed soon after September 27, 2007, and January 18, 2017, from disclosing negative results regardless of whether thousands of Americans use the product, which would be utterly contrary to the FDAAA’s aims.”

Joseph Ross, professor of medicine and public health and faculty co-director of the Yale Collaboration for Research Integrity and Transparency, called the judge’s ruling “an extraordinary victory for patients and clinical trial researchers.”

“The government now has a clear legal obligation to enforce these reporting requirements, and by doing so it will promote more fully informed decision-making by patients and their clinicians,” he added.

HHS did win on one point. And it’s a big win as it knocks the teeth out of the requirement to post the data. Under the FDAAA scheme, the FDA has the authority to issue notices of noncompliance to sponsors that don’t submit required trial results in a timely manner. Once those notices are sent, the NIH is tasked with publicly posting the notices and creating a search function in Clinicaltrials.gov for those notices.

So far, the FDA has used its discretion to not issue the notices – a decision that is immune from judicial review, Reice Buchwald said. She dismissed the plaintiffs’ challenge to the NIH’s failure to post the notices, since there are none to post.

No Comments