November 1974

What Should the Package Insert Be?

Author Affiliations

From the Department of Psychiatry, Research, and Evaluation, Long Island Jewish-Hillside Medical Center, Glen Oaks, NY.

Arch Gen Psychiatry. 1974;31(5):735-741. doi:10.1001/archpsyc.1974.01760170117018

The professional and legal status of the package insert needs radical revision. Currently this insert is considered part of drug labeling and must be approved by the Food and Drug Administration (FDA). The actions of the FDA are primarily regulatory with regard to industry, sales, and communications.

However, the package insert has achieved, in many physicians' minds, an unwarranted quasi-legal status so that an indication or dosage that is not specifically recommended becomes, by default, experimental or investigational and may open the physician to a charge of malpractice.

An alternative format for the package insert is described, with use of a pharmacotherapeutic monograph as a model. A partial example of such a procedure with chlorpromazine is offered.