The US Congress has passed the $6.3 Billion 21st Century Cures Act that is a grab bag of initiatives, with the primary focuses of expanding medical research and speeding up approval of new drugs and medical devices.  In my last blog post, I have discussed the recent rule changes to  ClinicalTrials.gov and focused on a more complete explanation of Responsible Party.  In this blog post,  I will discuss the implications these new laws have for trial compliance; specifically, the penalties for not providing trial results to trials registered on ClinicalTrials.gov.

In the past, many of our clients have asked if there are any penalties for non-compliance.  It's a good question, and tough to answer because the NIH has walked a “tight-rope” on the issue. On one hand they do have the power to fine or to “wave the stick” but in reality they've only  used strong language about compliance as a motivator to do it right, without dishing out penalties.  But the new legislation has us thinking that the change is coming. The new descriptions for non-compliance penalties are below.

"Judicial remedies for violations of section 301 of the FDC Act include injunctions and criminal penalties. Under section 302 of the FDC Act (21 U.S.C. 332), U.S. district courts have jurisdiction to restrain violations of section 301. Under section 303 of the FDC Act persons who violate section 301 can be imprisoned or fined. Pursuant to 18 U.S.C. 3571, current generally applicable fines are (1) for individuals, up to $100,000 for a misdemeanor, up to $250,000 for a felony violation and (2) for organizations, up to $200,000 for a misdemeanor, up to $500,000 for a felony violation. Such remedies could be accomplished through judicial proceedings initiated by FDA and brought to court by the Department of Justice."

(Source)

To paraphrase, an organization may be subject to $200,000 - $500,000 in fines through judicial proceedings for failing to maintain compliance with the FDA.

The effective rule changes will start April 18th, 90 days after the signing law which was January 18, 2017.  It seems safe to say that if enforced the new penalties will be taken more seriously by researchers. Life sciences professionals and patients all stand to gain from the wider adoption of trial disclosure practices, which we can expect to start taking place with these new rules.


We have a tool called TrialCompliance that checks for the compliance of trial protocols on ClinicalTrials.gov.

If you would like to see if your trial is compliant, or see if other business affiliates or competitors are compliant, sign up for an account of TrialCompliance. We'll provide your setup and the first two weeks free.

Or click here for more information on how TrialCompliance works.

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