In March we reported that a federal judge in New York ruled that 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 data from trial sponsors, said the judge, must now be reported to the FDA and made available to the public.
But there was a catch. The government could appeal the ruling and the disclosures and punishments for non-compliance hinged on FDA discretion. To date, the agency has not exercised its discretion to punish any trial sponsor for not submitting the required information.
“As Soon As Possible”
At the end of July, we learned that the government would not appeal the decision. HSS subsequently issued a letter through ClinicalTrials.gov telling sponsors to review their clinical trials at issue in the court ruling. If the product is already approved, companies “must submit” the required information “as soon as possible.” The government did not specify a timeline to submit the information.
If the product is not yet approved, licensed, or cleared by the FDA, then the results must be submitted within 30 days after FDA action.
Penalties and Sanctions
The letter stated that the National Institutes of Health (NIH) “may take action against responsible parties if they do not submit required results information.” Failure to submit required results could result in the FDA pursuing civil monetary penalties and not releasing remaining NIH funding for a grant or funding for a future grant.
Christopher Morten, a supervising attorney at New York University’s Technology Law and Policy Clinic, who represented the plaintiffs who brought the case to the federal court, said with the court’s decision, “those trial results are very clearly required, and the trial sponsors have a legal obligation to report them.”
Peter Lurie, a former associate FDA commissioner and plaintiff in the federal lawsuit, told Statnews.com that he expected little to change unless the agencies begin enforcing rules.
“Do I think I’ll be able to get my hands on those data? No, probably not. The FDA has not shown any interest in enforcing compliance with trial registry reporting requirements; I doubt that the court order will suddenly change their attitude. And without some penalty for noncompliance, I don’t think that the companies in question will decide to cough up the old data just because it’s the right thing to do.”
While the government has not penalized any trial sponsors to date, the handwriting is on the wall. Get your trial data in order.
