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October 31, 1977

The Patient Package InsertIs It Safe and Effective?

JAMA. 1977;238(18):1936-1939. doi:10.1001/jama.1977.03280190038024

ON MARCH 31, 1975, a group of consumer organizations petitioned the Food and Drug Administration to require that written warning information be provided to patients along with certain prescription drugs. The stated rationale was that physicians fail to inform their patients adequately about drug effects or that patients fail to comprehend or remember these warnings. Meetings were subsequently held by the FDA with a number of professional associations, including the American Medical Association. On Nov 7, 1975, the FDA published a Federal Register notice requesting comments on the "Patient Prescription Drug Labeling Project."1 Legislation introduced in both Houses during the last session of Congress advocated the patient package insert (PPI) concept, and similar bills introduced during the current session retain the same provision.

Thus, while some Washingtonians are advocating the PPI as "an idea whose time has come," one could say more fairly that the time for close scrutiny of