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Pharmaceutical Manufacturers Take Note: FDA Notice Requires Review and Certification of Drug Listings or They May Be Invalidated

In October 2016, FDA issued a final rule requiring FDA-registered drug companies to update or “certify” their current drug listings. Failure to comply not only would have implications for FDA regulatory compliance, but also could adversely affect reimbursement under both government and commercial plans and potentially lead to exposure under the False Claims Act.

Arent Fox previously discussed this requirement in an alert titled “FDA Requires Pharma Companies to Certify Drug Listing Info.” Just this week in a Notice of Intent FDA reminded pharmaceutical manufacturers that if their drugs were not appropriately updated, certified or associated with a registered establishment, they will be marked “inactive” by FDA and the date of inactivation added to the listing record. This will result in closure of drug records in all FDA public directories.

In the event drug listings are made inactive, this could potentially result in allegations of failure to comply with the FDCA or seizure. In addition, deactivation of FDA listings could result in CMS’ termination of a covered outpatient drug under the Medicaid Drug Rebate Program or denying the listing of a new covered outpatient drug under the Medicaid Drug Rebate Program given CMS’ reliance on the FDA public directories as the correct source for all covered outpatient drug product information.

We urge all pharmaceutical manufacturers to review your FDA listings and ensure they are updated and certified as current with FDA. If you have questions regarding the FDA certification process, please contract Stephanie Trunk, Emily Leongini or the Arent Fox attorney who currently handles your matters.  


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