In a just released U.S. Food and Drug Administration (FDA) guidance titled “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank,“ apparently industry sponsors (e.g. pharmaceutical, biotech, diagnostic and medical device companies) and principal investigators (from universities and health systems to individual researchers) are now formally on notice for their obligation to fully disclose research—both registering the clinical trial and reporting on the results.
Made available on August 12, 2020, the new guidance reflects the FDA’s thinking about how it will identify and potentially punish those sponsors and investigators that don’t follow the rules as associated with the FDA Amendments Act of 2007 along with final regulations promulgated in 2016 by the National Institutes of Health (NIH).
Transparency is Taken Seriously
The federal regulators are simply following up on the law of the land. That’s because for too long now there has been a somewhat lax compliance with the disclosure rules. But in a statement to the market, the FDA will focus on those sponsors or investigators who have disclosed false or misleading information or those that didn’t submit a proper certification to the FDA acknowledging the submitters obligation to comply with the law.
The FDA’s Bioresearch Monitoring Program, whose mission is to ensure good clinical practices, will be a primary vehicle to source information used for enforcement. This means that when FDA inspectors are involved with sponsors and sites, they’ll be connecting the dots to disclosure. But they’ll also encourage other methods, such as promoting complaints, sort of like a whistleblower deal.
Feds Get more Serious about Disclosure
Moving forward, the FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) as well as Center for Devices and Radiological Health (CDRH) could seek civil monetary penalties for a lack of proper disclosure. Should the agency find a breach of this duty, they’ll send a Preliminary Notice of Noncompliance (Pre-Notice). They’ll have 30 days to rectify the situation; otherwise, if they don’t, that triggers another visit to determine if the situation has been remedied. Still not taken care of, and the FDA could progress the enforcement to a “Notice of Noncompliance” and either levy money damages, trigger injunctions or in some cases, pursue criminal prosecution.