id	author	title	date	pages	extension	mime	words	sentence	flesch	summary	cache	txt
inlawrev-3603	Gongola, Janet A.	Prescriptions for Change: The Hatch- Waxman Act and New Legislation to Increase the Availability of Generic Drugs to Consumers	2003	40	.pdf	application/pdf	17878	1019	55	Indiana Law Review Prescriptions for Change: The Hatch-Waxman Act AND New Legislation to Increase the Availability OF Generic Drugs to Consumers* Janet A. Gongola'* Introduction In 1984, Congress attempted to delicately balance the interests of innovator pharmaceutical companies (innovators) and generic drug manufacturers (generics) by enacting the Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act.^ Congress guaranteed innovators seventeen-year patent terms to encourage the research and development ofvaluable new drugs.^ Moreover, the Amendment did not prevent the FDA from requesting additional clinical studies to address adverse reactions or other data published after initial approval of the innovator's drug.^* Thus, the 1962 Amendment essentially limited the number of generic drugs on the market and prolonged the time necessary to obtain approval for a new generic.	cache/inlawrev-3603.pdf	txt/inlawrev-3603.txt