The FDA issued a draft guidance in September 2018 to detail the regulatory body’s thinking on monetary penalties of up to $10,000 per day for failing to register a clinical trial, patterns of previous noncompliance, and/or submitting misleading or false information to ClinicalTrials.gov. While the FDA has not previously begun issuing fines to pharmaceutical companies, this guidance brings that reality one step closer.
Zach Weingarden, Product Solutions Manager, TrialAssure, helps clarify some common questions on this draft guidance that sponsors and other partners have been asking.
What does this guidance mean for pharmaceutical companies?
ZW: The possibility of financial penalties for non-compliance has always been present. It is written into the FDAAA, but just has not been enforced to this point. Thus far, drug sponsors primarily comply with clinical trial registration for the inherent ethical value of research transparency and the public perception of the company. Requirements for posting trial results are also linked to funding and publication as well. However, it is widely believed that the financial penalties – despite being written into law – have no teeth. This guidance is a large step towards changing that belief.
Why do you think that the FDA has not imposed fines to date?
ZW: Rather than being confrontational, the FDA takes the approach of educating sponsors and trying to help them reach compliance. I think there are several reasons why they most likely have not imposed fines, including: they do not want to enter a legal dispute and potentially disrupt research and they acknowledge that the requirements are not entirely clear, among others. Nevertheless, when the cost is calculated and the public realizes that the government is essentially leaving approximately $25 billion uncollected, there’s obviously a call for action. This article in STAT is a great resource for more on this topic.
Do you think imposing fines will mean that sponsors will spend more time focusing on disclosing clinical trial results?
ZW: I think the FDA is trying to send a clear message through this draft guidance, and now that the Final Rule is in place, they are going to get serious about these penalties. At the very least, the regulatory authority wants to give the impression they are headed in that direction. The rules for fines related to noncompliance have been in place for quite some time now, and with the tools available, there is really no reason why drug sponsors can claim unfamiliarity of their ClinicalTrials.gov responsibilities or compliance status.
What can pharmaceutical companies do to make sure they remain in compliance?
ZW: If you do not already centralize the responsibility to register clinical trials and disclose results, drug sponsors should, at the very least, centralize compliance monitoring so they can properly assess the pipeline holistically. Sponsors should also understand the Final Rule and how it specifically applies to their trials, or engage a partner who can help. If a sponsor struggles to meet the required deadlines, disclosure workflows should be reviewed from an efficiency standpoint. This is why it is essential to empower the right people and eliminate bottlenecks from the process.
To ask Zach additional questions, please email him at firstname.lastname@example.org.