Patient Package Inserts — The American Regulatory and Industry Perspective *

Abstract

The Food and Drug Administration (FDA) requires patient package inserts (PPJs) only for a limited number of medicinal products and therapeutic devices, including at least four classes of drugs (oral contraceptives, estrogens, progestational agents, and certain vaccines), five specific drugs (finasteride, isotretinoin, misoprostol, terfenadine, and triazolam), and one class of therapeutic devices (intrauterine devices). Although FDA's proposed pilot program of PPIs for 10 drugs and drug classes failed in 1979, FDA is reexamining the issue of PPIs in its MedGuide Project. This initiative contemplates a requirement for mandatory PPIs, including their provision with new drug applications (NDAs). Pharmaceutical manufacturers are concerned that PPIs will expose them to liability arising from loss of the learned intermediary defense.