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The Legal Status of Unapproved Generic Drugs

Published online by Cambridge University Press:  27 April 2021

Richard R. Abood
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Extract

Generic drugs that have not been specifically approved by the Food and Drug Administration (FDA) are today being marketed, and considerable legal controversy surrounds the issue of whether the FDA can require premarketing approval of generic copy drugs (“me-toos”).

Prescribers and dispensers of drugs cannot blindly assume that every drug on the market has been approved by the FDA, and that it will be safe and effective, as can be seen from the following incident. In September 1981, in an unprecedented action, an Ohio grand jury indicted a pharmacist for manslaughter in the death of a woman to whom he sold a furosemide product unapproved by the Food and Drug Administration. The woman died of congestive heart failure and the grand jury found probable cause that the death was caused by the diuretic. The drug was dispensed despite a March 30,1979,news release from the Department of Health, Education and Welfare warning that unapproved furosemide tablets were being marketed and that these drugs might be ineffective and could possibly be harmful.

Type
Pharmacy Law
Information
Law, Medicine and Healthcare , Volume 10 , Issue 1 , February 1982 , pp. 24 - 28
Copyright
Copyright © American Society of Law, Medicine and Ethics 1982

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References

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