In order to adequately prepare for a U.S. Food and Drug Administration (FDA) inspection, companies often need to be aware of some of the common areas targeted by the FDA, and have a thorough understanding of why these issues are addressed in FDA inspections.  This allows companies to set themselves up for success when it comes to passing their inspections. In this post, we will investigate some of the common areas of FDA enforcement, in addition to looking at what types of actions the FDA takes to enforce their regulations, and how best to respond to these enforcement actions.  

Who is Being Targeted and How?

The FDA routinely inspects a variety of organizations involved in clinical research including sponsors, clinical trial sites, and SMOs, and CROs.  

Institutional Review Boards

The FDA audits institutional review boards (IRB). IRBs are neutral third-party companies which review proposed research and ensure that it meets regulatory expectations.  The FDA has typically found that IRBs may lack adequate documentation, failed to follow their own written procedures, and/or failed to appropriately weigh the risks and benefits of proposed research studies.  

Sponsors

Sponsors are, generally speaking, pharmaceutical or medical device companies. As sponsors, they must ensure that studies are being monitored carefully and correctly, and that the site is performing its job according to protocol.  Failure to appropriately monitor the research may be citable by the FDA. Even though the study sponsor may delegate the work–including conducting research and studies–to other companies, the sponsor still retains responsibility and is held accountable if their work is not compliant with federal regulations.  Pharmaceutical companies can also be reprimanded by the FDA for failing to report outlying observations. This means that they must share potential problems with their drugs to FDA investigators, and make sure that all of their findings are fully reported.

Clinical Trial Sites

Clinical trial sites are yet another target for FDA enforcement, primarily if a site fails to promptly respond to FDA concerns.  The FDA may also inspect a site if it does not appear to adequately the safety and welfare of its patients or subjects. This could include a site failing to obtain IRB approval for changes to the protocol.  This means that doctors have ignored the steps given in a study’s protocol and were not compliant. Another problem facing clinical trial sites is failure to properly maintain case histories.  

Dealing with the Consequences

In instances where the FDA has already found something wrong with a clinical study, it may provide a titled or untitled letter such as a 483.  In cases such as these, companies may want to address the concerns listed in these letters, and possibly deal with the repercussions of an injunction which would require the company to go to court.  If a company is issued an injunction, it will have to face the possibility of stopping its clinical research altogether due to a court mandated order.  

One way of dealing with these injunctions is through corporate integrity agreements, which is an agreement in which companies must meet certain conditions in order to not be barred from the healthcare industry.  Although corporate integrity agreements seem like a good option to companies looking to escape injunctions, they are hefty sums–often in the hundreds of millions of dollars.

Another consequence facing healthcare providers is disbarment and disqualification.  This would mean that, for doctors and nurses who are a part of companies found to be in FDA violation, it would be illegal to work in companies which deal with the FDA or HHS.

The Importance of Compliance

Although compliance remains an expensive, time-consuming area for most companies, the consequences of not following FDA regulations demonstrate how important it is to be prepared for FDA inspections.  Ensuring that you have all of your documents in place, and are appropriately following protocols, is essential to remaining compliant and avoiding hefty fines and penalties.

If you have any other questions about how to communicate with the FDA or how your past and/or current FDA communications affect you and your business goals, reach out to me on Twitter, LinkedIn, or send me a message here.

I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the podcast on Google Play or on Soundcloud.

Blog Disclaimer

The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.