Medical advancement depends on clinical trials for new pharmaceuticals and treatments. The clinical researchers and physicians conducting these trials must adhere to the highest ethical and legal standards, with the U.S. Food and Drug Administration (FDA) holding them accountable. Researchers, vendors, and organizations who don’t uphold these standards or use data that lacks integrity could face debarment from future clinical trials by the FDA. We discuss what it means to be on the FDA debarment list for clinical trials and how healthcare professionals and organizations can avoid this designation.
What Lands Someone on the FDA Debarment List for Clinical Trials?
The FDA keeps a public record of individuals forbidden from working in the drug industry and pharmaceutical clinical trials. This debarment list provides the names of individuals convicted of or being investigated for non-compliance incidents.
The infraction applies to any stage of clinical drug research, from development to approval, that falls under the Federal Food, Drug, and Cosmetic Act. Violations can include:
- Failing to comply with FDA regulations regarding clinical trials
- Falsifying data to manipulate analyses
- Fabricating statements related to a clinical trial
- Illegally distributing or marketing pharmaceuticals without FDA approval
- Offering or accepting bribes to skew results
- Violating the rights of human subjects in clinical trials
Based on the nature and severity of these infractions, the FDA assigns two types of debarments:
- Mandatory: Resulting from a felony conviction, making the debarment permanent
- Permissive: For a misdemeanor conviction or judgment of conspiracy or accessory, resulting in a debarment that can last for several years
As you search the FDA debarment list for clinical trials, you should be familiar with documents like the Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) letter and the Notice of Opportunity for Hearing (NOOH). Each person on the list is assigned a status, depending on the stage of their investigations:
- Not disqualified: An investigation into a person has been discontinued, typically after the person provides a satisfactory explanation to the NIDPOE.
- Disqualified: Clinical investigators have been debarred because they have repeatedly or intentionally failed to comply with FDA regulations. They’re no longer eligible to receive drugs or products supporting future research or marketing permit applications.
- Totally restricted: This status also referred to “disqualified” individuals in the past. This designation refers to people ineligible to receive investigational products.
- Restricted: The person is eligible to receive clinical trial products and may enter into restricted agreements upon FDA approval.
- Restrictions removed: The FDA has removed prior limits, and the individual can receive investigational products, given they’re compliant with regulations.
Why Include the FDA Debarment List for Clinical Trials in Your Screenings?
If your healthcare organization tests, manufactures, administers, markets, or distributes pharmaceuticals or other clinically tested products, screening the individuals associated with those trials is essential. Employing people debarred by the FDA could have severe consequences, such as fines and other legal penalties. Also, having a debarred researcher associated with a product your entity is developing or using could cause devastating delays, fines, or even the debarment of your entire organization.
Whenever your entity applies for a new drug approval, you must verify that you’re not employing anyone on the FDA debarment list for clinical trials. Besides avoiding the legal ramifications of unintentionally hiring a debarred individual, monitoring the list communicates that your entity cares about data integrity and the protection of human subjects. It also helps you maintain your credibility with government agencies and the public.
How Software Helps You Monitor the FDA Debarment List for Clinical Trials
Having access to the FDA debarment database is helpful, but monitoring this list is one of the many tasks and responsibilities of compliance officers. It would be nice to automate these regular tasks so that nothing falls through the cracks.
Fortunately, software from Compliancy Group can help you automate checking the FDA debarment list and conduct other employment screenings. With our software, you can effortlessly search for employees and vendors using a centralized dashboard to integrate these searches into your workflow. You can also receive alerts and notifications as the debarment list and critical regulations evolve.
Given that most healthcare organizations are directly or indirectly involved with drug and product testing, your organization must know how to monitor the FDA debarment list for clinical trials. At Compliancy Group, we want to ensure that overlooking this list doesn’t undermine all your efforts.
Contact us today to learn what our compliance software can do for you.
