A federal judge in New York says the Department of Health & Human Services (HHS) made a mistake back in 2007, resulting in a 10-year gap in clinical data reporting through ClinicalTrials.gov that must be made available to the public.
The judge, Naomi Buchwald, said the agency “misinterpreted” a federal law requiring the agency to collect and post data for certain clinical trials.
As a result, medical device manufacturers, drug companies and academic institutions will eventually be required to post previously undisclosed data from clinical trials conducted between 2007 and 2017.
But there’s one big caveat. The disclosures and punishments for non-compliance hinges on FDA discretion.
Reporting Requirements
Here’s what happened.
In 1997, the government developed the ClinicalTrials.gov platform to establish a data bank of information of clinical trials that could be accessed by the public.
In 2007, further reporting requirements were passed by Congress to, “increase the availability of information to the public” in order to “help patients, providers and researchers learn new information and make more informed healthcare decisions.” The additional requirements obliged “responsible parties” to submit specified “Basic Results” to NIH (National Institutes of Health) for inclusion in ClinicalTrials.gov for certain applicable clinical trials (ACTs).
In January 2017, HHS issued a Final Rule for the additional requirements.
The final rule declared that for ACTs of a product that is approved, licensed or cleared by FDA, Basic Results must be submitted within a certain time period. However, for ACTs of a product that is not approved, licensed or cleared by FDA, Basic Results must be submitted only if the ACT had a primary completion date on or after January 17, 2017. If the ACT was completed after 2007 but before the effective date of the HHS Final Rule, Basic Results were not required to be submitted or posted if the ACT was for a product that was approved after the ACT was completed.
Lawsuit
Charles Seife, an investigative journalist, and Peter Lurie, a former FDA associate commissioner who is also president of the public health watchdog Center for Science in the Public Interest, didn’t like that rule and sued.
The judge said the 2007 changes unambiguously requires responsible parties to submit, and defendants to include on ClinicalTrials.gov, Basic Results for pre-Rule, pre-approval ACTs.
HHS argued that it was wrong to require a retroactive application of the law. Judge Buchwald didn’t buy any of that. The judge said HSS knew since 2007 that they were required to submit Basic Results for each ACT of a product that is approved. It was only in the 2016 HHS Final Rule, where HHS told parties they weren’t required to submit Basic Results for pre-Rule, pre-approval ACTs, that this requirement changed.
So, what happens now?
According to Hyman, Phelps & McNamara, P.C.’s law blog:
“While the court’s decision requires the results of clinical trials conducted in unapproved products between September 2007 and January 2017 to be posted on ClinicalTrials.gov, it is unclear whether FDA will require responsible parties to report, how long responsible parties have to report, and for HHS to subsequently post, such data.”
We’d be making sure our files were in order.
