Dr. Bandyopadhyay:
It is possible that the person meant the "Park Doctrine," consistent with which FDA can prosecute a "responsible corporate official" (RCO) for a criminal violation of the Federal Food, Drug, and Cosmetic Act if the violation occurred at the official's company and the official was in a position to prevent the violation from occurring or correct it if discovered.
The Park Doctrine is a key theory of liability that is designed to ensure compliance with the laws FDA enforces. For a more thorough discussion of the Park Doctrine, please refer to a recent client alert that I wrote that contains an overview of the Park Doctrine. You can access that alert at:
http://www.duanemorris.com/alerts/dc_circuit_affirms_hhs_power_disqualify_corp_officials_convicted_misdemeanors_rco_doctrine_4559.html And, if you have any additional questions, feel free to contact me at my San Diego office.
Regards,
Michael Swit, Esq.
______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
P: +1 619 744 2215
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maswit@duanemorris.com Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.
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Original Message:
Sent: 10-30-2012 12:50
From: Keya Bandyopadhyay
Subject: PERK rule
Hi,
Someone asked me about PERK rule of the regulatory arena. I had extensively searched, but did not find anything.
Any input in this regard would be highly appreciated.
Thanks in advance.Keya
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Keya Bandyopadhyay RAC
Senior Scientist
Torrey Pines Institute For Molecular Studies
San Diego CA
United States
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