The Package Insert

The obligation of the Food and Drug Administration to exercise surveillance over statements in the package insert and to determine their accuracy and veracity confers an undeserved aura of legality upon the document. Physicians have become alarmed because the brochure has on occasions been introduced as evidence in cases of litigation arising from alleged malpractice. A resume of a conference on the package insert between representatives of the AMA and FDA appears in question-and-answer form elsewhere in this issue of The Journal (p 1335). The legal staff of the AMA comments that the subject matter in the resume is factual, but that it represents the FDA's interpretation of the regulations. The legal staff aptly cautions that the rules of evidence vary from state to state and that generalizations in the resumé pertaining to legal liability of a physician may not be equally applicable to all jurisdictions. Furthermore, the weight a