id	author	title	date	pages	extension	mime	words	sentence	flesch	summary	cache	txt
ihlr-20834	Olson, Tyler W.	The Supreme Court's Overreaching Preemption Interpretation and Its Consequences: Granting Generic Drug Manufacturers Legal Immunity Through "The Duty of Sameness" in Mutual Pharmaceutical Co. v. Bartlett and PLIVA v. Mensing	2015	41	.pdf	application/pdf	13512	670	51	When the Hatch-Waxman Act was enacted in 1984, generic drugs accounted for 19% of all drug sales in the United States.56 The Hatch-Waxman Act’s ANDA process allowed generic drug manufacturers to enter the marketplace without the restraints new brand name drug manufacturers face. This labeling requirement has been argued (and interpreted) as meaning generic drug manufacturers are not able to unilaterally change their labels to strengthen warnings.69 The FDA approves generic drugs only if they are determined “safe for use” under “conditions of use 62 Wyeth, 555 U.S. at 578-79.	cache/ihlr-20834.pdf	txt/ihlr-20834.txt