1/24/2018 First Amendment to the Food,Drug First Amendment to the Food,Drug and Cosmetic Act and Cosmetic Act Insulin Amendment,1941 US v.Dotterweich,1943 University of Toronto -Dotterweich,president and general two researchers discovered insulin manager of Buffalo Pharmacal Company. Inc. -had a patent on the product Purchased drugs from manufacturers -recognized importance of standard repacked them under its own label,and potency shipped them in interstate commerce -Three counts went to the jury-two,for created a licensing committee to shipping misbranded drugs in interstate maintain standards commerce and a third for shipping an adulterated drug First Amendment to the Food,Drug and Cosmetic Act Public Health Service Act US v.Dotterweich,1943 .1944,signed by Roosevelt Jury found him guilty of all three -provides grants-in-aid to research accounts institutes for studying diseases Supreme court ruled the responsible -expanded the federal-state cooperative officials of a corporation and the public health programs corporation itself may be prosecuted for established a national tuberculosis violations control program President should be aware of the regulations related to their business includes:Office of Surgeon General, National Institutes of Health(NIH) Criminal liability imposed on a person Bureau of State Service and Bureau of responsible for public well-being Medical Services 1/24/2018 18 First Amendment to the Food, Drug and Cosmetic Act Insulin Amendment, 1941 • University of Toronto - two researchers discovered insulin - had a patent on the product - recognized importance of standard potency - created a licensing committee to maintain standards First Amendment to the Food, Drug and Cosmetic Act • US v. Dotterweich, 1943 - Dotterweich, president and general manager of Buffalo Pharmacal Company, Inc. - Purchased drugs from manufacturers, repacked them under its own label, and shipped them in interstate commerce - Three counts went to the jury - two, for shipping misbranded drugs in interstate commerce and a third for shipping an adulterated drug First Amendment to the Food, Drug and Cosmetic Act • US v. Dotterweich, 1943 - Jury found him guilty of all three accounts - Supreme court ruled the responsible officials of a corporation and the corporation itself may be prosecuted for violations - President should be aware of the regulations related to their business - Criminal liability imposed on a person responsible for public well-being Public Health Service Act • 1944, signed by Roosevelt - provides grants-in-aid to research institutes for studying diseases - expanded the federal-state cooperative public health programs - established a national tuberculosis control program - includes: Office of Surgeon General, National Institutes of Health (NIH), Bureau of State Service and Bureau of Medical Services