Generic drugs competition

In April 2001, the Commission began an industry-wide study foeused on certain aspects of generic drug competition under the Hatch-Waxman Amendments. ... 

The Amendments provide certain methods by which generic drug manufacturers can obtain approval to market a generic version of a brand-name product. The study s purpose was to provide a more complete picture of how generic drug competition has developed under one method the Amendments established generic entry prior to expiration of the brand-name company s patents on the relevant drug product. This report sets forth the results of the study. ... 

This chapter reviews FDA regulations concerning the use of citizen petitions. It also examines the citizen petitions that brand-name companies have filed about drug products in this study, and discusses their effect on the development of generic drug competition for these drug products. 

As patents expire, exclusivity of producing a trade-nemed product will pass and competitive-versions of the basic drug will be marketed under generic names (or other new trade nemes) by new manufacturers. It has been estimated that 40% of the drugs on the market in 1990 will be generic drugs. 

An increase in competition between manufacturers of generic drugs does indeed cause a drop in prices. The entry of each new competitor brings about a price reduction of between 5.6 per cent and 7.2 per cent an increase from three to six competitors results in a drop of between 17 per cent and 22 per cent. 

Fines Enhancement Laws of 1984 and 1987 increase penalties for all federal crimes, with double fines for corporations. The Drug Price Competition and Patent Term Restoration Act expedites the availability of less-costly generic drugs by permitting FDA to approve generics without repeating the safety and effectiveness research. 

Congressional Budget Office (CBO), How increased competition from generic drugs has affected policy and returns in the pharmaceutical industry, U.S. Government Printing Office, Washington, DC, 1998. 

Bureau of Economics Staff Report, Federal Trade Commission, The Pharmaceutical Industry A Discussion of Competitive and Antitrust Issues in an Environment of Change (Mar. 1999) available at David Reiffen and Michael R. Ward, Generic Drug Industry Dynamics, Bureau of Economics Working Paper No. 248 (Feb. 2002) ( Reiffen and Ward ), available at... 

Congressional Budget Office, How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry (July 1998) ( CBO Study) at 28, available at... 

Drug Price Competition and Patent Restoration Act of 1984 Abbreviated new drug applications for generic drugs. Required bioequivalence data. Patent life extended by amount of time drug delayed by FDA review process. Cannot exceed 5 extra years or extend to more than 14 years post-NDA approval. 

The ffatch-Waxman Act, or the Drug Price Competition and Patent Term Restoration Act, makes it easier for generic drugs to get approval from the FDA but also allows drug companies to extend their patents when the FDA approval process delays the sales of patented drugs. 

Henry Waxman, Democratic representative from California since 1975. In an unusual instance of cooperation across parties, Waxman cosponsored a bill in 1984 with conservative Republican senator Orrin Hatch called the Drug Price Competition and Patent Restoration Act. The bill helped consumers by making it easier and faster for less expensive generic drugs to get approval from the FDA. It helped drug companies by allowing their patents to be extended when the development and approval process took a particularly long time. 

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