FDA Repels Attack on Generics. Essential Drugs Monitor No. 004 (1987)
(1987; 2 pages)


In September 1984, the United States enacted the Drug Price Competition and Patent Term Restoration Act. Among other things, the Act provided for the expedited approval of generic substitutes for brand name pharmaceuticals by the Food and Drug Administration (FDA). This law expanded the market for generics but caused concern from the public about the adverse consequences of generics. The fourth issue of the Essential Drugs Monitor summarizes a report produced by the FDA to refute 10 common myths about generic drugs. First and foremost, the new law did not eliminate any safety and effectiveness testing requirements for generics and there is no evidence of adverse reactions resulting from generic use. The FDA also stated that it requires generics to be bioequivalent to their brand name counterparts, uses standard testing procedures with standard statistical analyses to test generics, and does not apply lower standards for generics. Additionally, no one has demonstrated that generic drugs differ in quality from brand name counterparts and the FDA is not aware of any documented bioequivalence differences for an approved generic drug. (Abstract by Flannery Bowman)

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