US FDA May Clarify When Execs Can Be Criminally Prosecuted Under Park Doctrine
Agency is considering whether a breach of duty to act or correct violations under the Food, Drug and Cosmetic Act must occur before criminal charges are brought, Chief Counsel Rebecca Wood says; clarity on FDA's view of 'vicarious criminal liability' would be welcome news to the pharma industry and suggests an early priority for the agency's new top lawyer.
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Policy revisions on individual liability for corporate misconduct, noncompliance with agency guidance documents and dismissal of False Claims Act cases suggest a greater willingness by DoJ leadership to reconsider arguments often raised by life sciences companies, attorneys say at a Food and Drug Law Institute conference.
FDA will soon announce a permanent successor to Wood, who is leaving in July after about a year in the post, FDA Commissioner Gottlieb says. In the interim, Lowell Schiller, senior counsel to the commissioner and a former Senate HELP Committee staffer, will lead the chief counsel's office on an acting basis.
A permanent successor to Wood, who will have held the agency's top legal post for only a year, will be announced in the near future, FDA Commissioner Gottlieb says; in the interim, Schiller, senior counsel to the commissioner and a former Senate HELP Committee staffer, will lead the chief counsel's office on an acting basis.