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January 10, 2007

A New Era of Unapproved Drugs: The Case of Abigail Alliance v Von Eschenbach

Author Affiliations

Author Affilations: Center for Law, Ethics, and Health, University of Michigan School of Public Health, Ann Arbor (Mr Jacobson); and Northeastern University School of Law, Boston, Mass (Ms Parmet).

JAMA. 2007;297(2):205-208. doi:10.1001/jama.297.2.205

More than 100 years ago, ineffective and often dangerous medicines were widely sold. Then, in 1906, the US Congress enacted the Pure Food and Drug Act,1 prohibiting the sale of misbranded, mislabeled, or adulterated foods and drugs in interstate commerce. Over the next 60 years, Congress tightened drug industry regulation, requiring manufacturers to demonstrate to the Food and Drug Administration (FDA) that their products are both safe and effective.