id	author	title	date	pages	extension	mime	words	sentence	flesch	summary	cache	txt
ihlr-16572	Bouggy, Brian B.	Follow-On Biologics Legislation: Striking a Balance Between Innovation and Affordability	2010	30	.pdf	application/pdf	11935	718	52	[T]he number of new drug patents issued by the U.S. Patent Office rose dramatically after 1984 and, in­ deed, has exceeded the pre-1984 levels in each year since the Act was promulgated.168 The debate regarding whether generic biologics should be approved by FDA centers around two main areas of contention: 1) whether it is feasi­ ble for generic drug companies to replicate name brand biologics safely and effectively; and 2) whether the introduction of generic biologics into the marketplace will destroy name brand drug companies' incentive to innovate by rendering the drugs unprofitable.44 ·Not surprisingly, viewpoints of in­ terested parties on the viability of follow-on biologics, and the effect they would have on our nation's health care system, vary greatly.45 Generic versions of chemical drugs, manufactured using precise chemical formulas, reach market through the abbreviated regulatory path­ way provided by the Drug Price Competition and Patent Term Restoration Act, more commonly referred to as the Hatch-Waxman Act.46	cache/ihlr-16572.pdf	txt/ihlr-16572.txt