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US FDA May Clarify When Execs Can Be Criminally Prosecuted Under Park Doctrine

Executive Summary

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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US FDA Chief Counsel Rebecca Wood Steps Down

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.

US FDA’s Lowell Schiller Steps In As Acting Chief Counsel When Rebecca Wood Departs In July

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.

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