As a healthcare business owner, staying compliant with regulatory requirements is essential to the success and positive reputation of your business. One primary aspect of compliance is ensuring you are checking the FDA debarment list to verify that those involved in your operations aren’t essentially banned from working in the drug industry.
This often presents a challenge for many healthcare business owners who may not know how to approach and search the list or how to cross-reference multiple lists as needed. Instead of maintaining manual processes that waste time and increase confusion, consider a simpler method of utilizing the FDA debarment list and similar resources — the right software solution.
Before Using the FDA Debarment List
The FDA Debarment List is a record of individuals and companies that are prohibited from providing any services or participating in transactions or general business with the U.S. Food and Drug Administration. The purpose of this list is to help businesses stay within compliance with FDA regulations and to safeguard public health. This is done by preventing those with a history of regulatory non-compliance from engaging in FDA-related activities altogether.
This list helps businesses with eligibility verification, assists them in protecting themselves against liabilities, and helps them positively maintain a company’s image.
Consider the Implications of Debarment for Healthcare Businesses
For healthcare businesses, being associated with a debarred individual or group can lead to a variety of consequences. These consequences often range from legal repercussions, monetary losses, reputational damages, and contract terminations.
Doing an FDA debarment list search is one of the simplest ways to mitigate the risk of these events. Consider that in the last fiscal year alone, more than 5000 people were either suspended or completely debarred. With such a high number of people being reported, compliance officers should implement an FDA debarment list check as part of their company’s internal vetting processes.
How to Get the Most Out of the FDA Debarment List
Approaching the FDA debarment list can seem daunting and potentially problematic, depending on the results of your search. However, there are a few best practices for approaching this list:
- Monitor the list regularly if needed
- Cross-check with other regulatory databases
- Enhance your documentation management efforts for each review
- Utilize screening tools
Adopting these strategies can eliminate the waste of resources and finances and prevent the chance of hiring a debarred vendor or individual.
What to Do if a Vendor Appears on the FDA Debarment List
Some businesses may be concerned when they discover that a vendor is on the FDA debarment list. While this can be alarming, the next step is to respond quickly.
Taking quick action after conducting an FDA debarment list search should consist of a few things.
Cease All Related Services or Current Contracts
The first step is to immediately halt any ongoing contracts with the individual or vendor that was found after completing an FDA debarment list check. Compliance officers also have to consider that the debarment list is meant to prevent companies from hiring someone who is banned from working within the drug industry unknowingly or by accident.
Once the observation is made, an organization should report the discovery immediately, as hiring someone on the FDA debarment list can cost upwards of $250,000 per person in penalties, which may be difficult for small to midsize companies to financially recover from.
Opt for an Internal Review
After an FDA debarment list search, conducting a comprehensive internal review can help a company gain more insight into the barred person or entity. What is found during this review can also help provide additional safety for the business in the case they incur a fine(s).
The internal review should include details on all past collaborations and contracts as well as anything that may be deemed relevant to the case.
Report to Relevant Authorities if Needed
In some cases, you may be required to report your findings to regulatory authorities. This is especially true if your organization has checked the FDA debarment list of clinical investigators and unknowingly continues to work with a debarred person. In this case, the violation will likely be further investigated by the FDA’s Office of Criminal Investigation.
Leverage Technology to Complement an FDA Debarment Check
By leveraging technology and industry best practices, healthcare business owners can enhance their regulatory compliance efforts, prevent risky incidents within the hiring process, and mitigate potential cases of non-compliance.
To approach the identification of those that fall within the FDA debarment list of clinical investigators, start prioritizing a software solution built to protect your operations and the reputation of your practice.
