Recently, the United States Food and Drug Administration amended its general drug labeling provisions to include warnings on numerous over-the-counter drugs. These changes are directed at protecting consumers who are either pregnant or nursing their infants. As a result, manufacturers of thousands of over-the-counter drug products have until December 5, 1983, to comply with the new labeling requirements. This Comment briefly reviews the scientific information that led to the new labeling requirements and gives a historical perspective of the government's role in protecting the American consumer from dangerous drugs. It also explores the drug manufacturer's role in the entire process and examines the various tort liability theories involved. Finally, this Comment analyzes the new federal regulations, including their potentially unwelcome side effects.
David DeTar Newbert,
Drugs during Pregnancy: Dangerous Business—The Continued Movement to Provide Adequate Warnings for the Consumer,
62 Neb. L. Rev.
Available at: http://digitalcommons.unl.edu/nlr/vol62/iss3/4