PHP 316 Lecture Notes - Lecture 8: Prescription Drug User Fee Act, Prescription Drug Marketing Act, Red Yeast Rice
Document Summary
Chapter two (cid:862)federal regulation of medications: development, production, a(cid:374)d marketi(cid:374)g(cid:863) Regulation of all drugs introduced into interstate commerce. Protects consumers from adulterated or misbranded foods, drugs cosmetics an devices. No new drug may be marketed/sold unless proven safe and effective and approved by the fda: historical overview of the federal food, drug and cosmetic act. 1800s u. s. law against adulterated food and drugs: advances in analytical chemistry and microscopy technology, studies showing impact of adulteration on humans. Pure food and drug act of 1906 misbranding and adulteration. 1906 (cid:862)the ju(cid:374)gle(cid:863) (cid:271)(cid:455) upto(cid:374) i(cid:374)(cid:272)lai(cid:396) meat industry. Made false claims about cancer (johnson) congress went back to clean up act. (cid:862)mis(cid:271)(cid:396)a(cid:374)di(cid:374)g(cid:863) did not prevent false or misleading efficacy claims. (cid:862)mis(cid:271)(cid:396)a(cid:374)di(cid:374)g(cid:863) o(cid:374)l(cid:455) to(cid:449)a(cid:396)ds d(cid:396)ug"s id strength, quality, purity: manufacturers left out ingredients, directions, warnings, did not include devices/cosmetics. 1912 amend act prohibit false and fraudulent efficacy claims: hard to enforce gov had to prove false claims and violators plead ignorance.
