FDA Resurrects Park Doctrine in Enforcement of Pharmaceutical GMPs
This article was originally published in The Gold Sheet
FDA is following through on earlier threats to dust off the long-dormant Park doctrine for holding chief executive officers of pharmaceutical companies personally accountable for manufacturing problems.
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FDA could seek misdemeanor charges against J&J officers under the Park Doctrine, which can be invoked against executives who could have prevented adulteration or misbranding of a drug. California Republican Issa says regardless whether criminal indictments come, the case "could be fair warning" to other firms regarding quality system failures.