FDA Issues Lifetime Drug Industry Ban on Convict.
Published Date: 3/13/2025
Notice
Summary
John Warrington Kosolcharoen is permanently banned by the FDA from working with any drug companies because he was convicted of a serious crime related to drug regulations. He didn’t respond to the FDA’s notice, so the ban starts on March 13, 2025, and lasts forever unless he applies to end it. This means he can’t be involved in drug approvals or related work, impacting his career and any companies he might have worked with.
Analyzed Economic Effects
4 provisions identified: 1 benefits, 3 costs, 0 mixed.
Permanent debarment from drug-related work
John Warrington Kosolcharoen is permanently barred from providing services in any capacity to a person that has an approved or pending drug product application, including biologics license applications (BLA). The debarment is effective March 13, 2025, and is based on his felony conviction on September 30, 2024, for introducing an unapproved drug into interstate commerce.
Penalties for hiring or using his services
Any person with an approved or pending drug product application who knowingly employs, retains as a consultant or contractor, or otherwise uses the services of Mr. Kosolcharoen during his debarment will be subject to civil money penalties under section 307(a)(6) of the FD&C Act; Mr. Kosolcharoen himself will face civil money penalties under section 307(a)(7) if he provides services during debarment.
FDA will not accept his abbreviated drug applications
During his period of debarment, FDA will not accept or review any abbreviated new drug application (ANDA) from Mr. Kosolcharoen, except in connection with an audit under section 306(c)(1)(B) of the FD&C Act.
Right to apply for special termination at any time
Mr. Kosolcharoen may apply at any time for special termination of debarment under section 306(d)(4) of the FD&C Act. Applications can be submitted electronically to regulations.gov (which will be posted publicly) or as written/paper submissions with a designated confidential copy and a public redacted copy.
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