Checking for Debarment: Section 306 of the FDA Act

We were curious how member organizations handle ensuring that none of the employees hired have been debarred under the section 306 of the FDA Act. This section requires that drug product applications received by the FDA after 1992 for NDA's, ANDA's, PLA's, and BLA's must include a certification statement that none of the employees (and there are other categories as well) utilizied in the connection with the development and submission have ever been debarred. According the regs, you can have employees complete a certification or check an FDA website which is updated quarterly. Are any of you familiar with this and have incorporated it into your new hire processes?

RESPONSES:
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We have built this check into our hiring process, both for employees and consultants. For employees, it is part of our background checks. We use a company called Certiphi, as they have a Sanctions check against the FDA and the like. We just started doing the same for employees. To document the process, it is stated in our Work Instruction Document for our Hiring Process. However, you can do this manually. Once a year, we chose year end, we run an audit of any actions that may have taken place throughout the year. We simply run an active employee list and an an active consultant list and run the list off the FDA public website and compare. I am attaching a document we created just to document this process. The website is below. Hope that helps! http://www.fda.gov/ora/compliance_ref/debar/
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Yes, this as part of the new hire process. We simply have a form for them to check yes or no if they have every been debarred, then they sign and date and it goes in their personnel file.
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We have a statement in our offer letters and will be putting it on our employment application as well.
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At another company, we had the background check company include this item in their report on each new hire. The background check company included it for a nominal charge.
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We check the FDA website for each new employee as part of the pre-offer process.
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Unfortunately I am not familiar with this, however, would be very interested in receiving information from your responses
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I have never heard of this, and would greatly appreciate any feedback you receive.
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