Court Ruling on clinical data not posted on

We gladly receive and publish the article by Robert Paarlberg on the recent ruling which envisages a new interpretation regarding the publication obligations of clinical trials prior to 2017 on

On February 24th a New York fed­er­al judge ruled on a case related to the FDAAA Final Rule stating that FDA and the NIH have for years mis­in­ter­pret­ed the Final Rule that would re­quire com­pa­nies, uni­ver­si­ties and oth­er clin­i­cal tri­al spon­sors to re­lease tri­al da­ta from stud­ies com­plet­ed be­tween 2007 and 2017. The rul­ing cov­ers drugs and med­ical de­vices that were ex­per­i­men­tal when the study was com­plet­ed but have since been ap­proved, po­ten­tial­ly putting hun­dreds of spon­sors out of com­pli­ance if they don’t put their re­sults on Clin­i­cal­Tri­

The case was brought by for­mer as­so­ciate FDA com­mis­sion­er Pe­ter Lurie and New York University jour­nal­ist Charles Seife. Peter Lurie wrote an article in Stat News June 4, 2019 titled “Hiding in plain sight: The FDA’s approach to disclosing new drug applications is a disservice to public health”.  He is currently President of the Center for Science in the Public Interest, a non-profit watchdog organization.

The Final Rule (42 C.F.R. § 11) limited requirements for providing basic results of Applicable Clinical Trials (ACTs) that completed before the rule’s enactment on January 18, 2017. Under the Final Rule, results for those trials were only required if the product was approved (or the device cleared) for any use before the trial’s completion date.

However, under the original FDAAA 801 rule, it was generally understood that results for ACTs were required within 12 months of the completion date or 30 days after the product approval, whichever came later, irrespective of whether the product was approved before or after the trial completion date. If this ruling stands, it reinstates this requirement that results must be posted for all pre-Final Rule ACTs within 12 months of completion or 30 days after approval (whether the approval came before or after the trial’s completion date).

It is not clear how this ruling will be enforced. The Court ruling could still be challenged by the FDA and NIH lawyers.

The ruling might ‘prompt’ FDA to finalize their draft guidance “Civil Money Penalties Relating to the Data Bank (September 2018)”.

Below are articles on this ruling: