Drug Price Competition and Patent Term Restoration Act

Drug Price Competition and Patent Term Restoration Act

Long title	An Act to amend the Federal Food, Drug, and Cosmetic Act to revise the procedures for new drug applications, to amend title 35, United States Code, to authorize the extension of the patents for certain regulated products, and for other purposes.
Acronyms (colloquial)	Hatch-Waxman amendments
Enacted by	the 98th United States Congress
Effective	September 24, 1984
Citations
Public law	98-417
Statutes at Large	98 Stat. 1585
Codification
Acts amended	Federal Food, Drug, and Cosmetic Act
Titles amended	21 U.S.C.: Food and Drugs
U.S.C. sections amended	21 U.S.C. ch. 9 § 301 21 U.S.C. ch. 9, subch. V §§ 355 & 360cc
Legislative history
Introduced in the Senate as S. 1538 by Charles Mathias (R–MD) on June 23, 1983 Committee consideration by Judiciary Passed the Senate on June 29, 1984 (voice vote agreed) Passed the House on September 6, 1984 (voice vote agreed, with amendments) Reported by the joint conference committee on September 6, 1984; agreed to by the Senate (agreeing to House amendments) on September 12, 1984 (voice vote) and by the Senate on September 19, 1984 (signed) Signed into law by President Ronald Reagan on September 24, 1984

Regulation of therapeutic goods in the United States
Prescription drugs Over-the-counter drugs
Law Federal Food, Drug, and Cosmetic Act CDAPCA Controlled Substances Act Prescription Drug Marketing Act Hatch-Waxman Act exemptions Marihuana Tax Act of 1937
Government agencies Department of Health and Human Services Food and Drug Administration Department of Justice DEA
Process Drug discovery Drug design Drug development New Drug Application Investigational New Drug Clinical trial phases Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off-label use
International coordination ICH Uppsala Monitoring Centre WHO CIOMS Single Convention on Narcotic Drugs
Non-governmental organizations National Academy of Medicine RADAR NORML
v t e

The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that established the modern system of generic drug regulation in the United States. The Act's two main goals are to facilitate entry of generic drugs into the market and to compensate the original drug developers for regulatory delays by the Food and Drug Administration. It is generally believed that the Act accomplished both goals: encouraging development of new medications and accelerating market entry of generics.^[1]

Representative Henry Waxman of California and Senator Orrin Hatch of Utah sponsored the act.