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Products liability and "off-label" use of prescription drugs

Article Abstract:

Charging drug manufacturers with a duty to warn of all demonstrated risks associated with off-label use of a drug is the most efficient way of dealing with liability for injuries resulting from off-label drug use. The demonstrated risk approach serves to reduce social costs borne by the pharmaceutical industry while providing physicians with the freedom to prescribe drugs for off-label purposes. This approach is less costly to society than the foreseeable misuse rule and recognizes that seeking FDA approval for all uses would be cost-prohibitive for manufacturers.

Author: Stoffelmayr, Kaspar J.
Publisher: University of Chicago Law School
Publication Name: University of Chicago Law Review
Subject: Law
ISSN: 0041-9494
Year: 1996
United States, Drugs, Cases, Laws, regulations and rules, Pharmaceutical industry, Product liability, Prescriptions (Drugs), Products liability, Off-label prescribing, Off label prescribing

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Tunnel vision: the war on drugs, 12 years later

Article Abstract:

The Reagan and Bush administration's war on drugs was a failure. In the first place, the effects of drug abuse pale beside those of alcohol and tobacco use. Rather than fighting drug abuse through education and treatment, Reagan and Bush chose to pour all funds into law enforcement, resulting in overcrowded prisons and court congestion so severe that federal judges no longer have enough time to devote to their civil dockets. Punishing drug users has been seen as so paramount that their human rights received little protection.

Author: Baum, Dan
Publisher: American Bar Association
Publication Name: ABA Journal
Subject: Law
ISSN: 0747-0088
Year: 1993
Evaluation, Political aspects, Narcotics, Control of, Narcotics control, United States. Office of National Drug Control Policy

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Realized benefits from switching drugs

Article Abstract:

The policy of switching drugs to nonprescription status has real economic benefits, as shown by an analysis of cold and cough medicines. The study uses a model for benefits and costs and addresses the switching policy of the Food and Drug Administration. However, the success of policy to date does not justify indiscriminate switching, since there is a danger of self medication replacing necessary visits to the doctor.

Author: Temin, Peter
Publisher: University of Chicago Press
Publication Name: Journal of Law and Economics
Subject: Law
ISSN: 0022-2186
Year: 1992
Economic aspects, Nonprescription drugs, Pharmaceutical policy

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