Commentary |

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

Peter D. Jacobson, JD, MPH; Wendy E. Parmet, JD
JAMA. 2007;297(2):205-208. doi:10.1001/jama.297.2.205.
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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.

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