FDA Bans Drug Felon Bernardo Garmendia for Life from Industry
Published Date: 3/14/2025
Notice
Summary
Bernardo Garmendia has been permanently banned by the FDA from working with any drug companies because he was convicted of a serious crime related to drug approval. He asked for a hearing but didn’t provide enough info to get one. This ban starts on March 14, 2025, and Garmendia can apply to end it later, but only through a formal process.
Analyzed Economic Effects
4 provisions identified: 1 benefits, 3 costs, 0 mixed.
Permanent ban on working for drug sponsors
Bernardo Garmendia has been permanently debarred by FDA from providing services in any capacity to a person with an approved or pending drug product application, effective March 14, 2025. The debarment follows his June 20, 2023 conviction for conspiracy to commit wire fraud related to clinical trial conduct.
Civil penalties for using or providing banned services
Any person with an approved or pending drug product application who knowingly uses Garmendia’s services during his debarment will be subject to civil money penalties; Garmendia likewise will be subject to civil money penalties if he provides services during his debarment. These penalties arise under sections 307(a)(6) and 307(a)(7) of the FD&C Act.
FDA will not accept ANDAs tied to debarred person
During Garmendia’s period of debarment, FDA will not accept or review any abbreviated new drug applications (ANDAs) submitted by or with his assistance. This restriction applies for the duration of the permanent debarment effective March 14, 2025.
Right to apply to end debarment (submission rules)
Garmendia may apply for termination of his debarment under section 306(d) of the FD&C Act by submitting an application to FDA. Applications may be submitted electronically at https://www.regulations.gov or as written/paper submissions to the Dockets Management Staff, and confidentiality procedures are provided for sensitive information.
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