Federal Trade Commission Weighs in on Access to Generic Drugs
23 Jul 2006
On Thursday, July 20, the Commissioner of the Federal Trade Commission (FTC) testified before a U.S. Senate committee, addressing the issue of competition between name-brand and generic pharmaceutical manufacturers. Among the topics that he raised, Commissioner Jon Leibowitz discussed the potential barriers to accessing generic drugs as a result of settlements arising from patent infringement litigation.
In his testimony before the Senate Special Committee on Aging, Commissioner Leibowitz stated that "anticompetitive" practices in the marketing of pharmaecuticals have--in many instances--prolonged the amount of time taken to bring generic medicines to consumers. Specifically, concerns have arisen from name-brand drug manufacturers' use of provisions in the Hatch-Waxman Amendment(s) to the Food, Drug, and Cosmetic Act (1984), effectively slowing or blocking the entry of generics into the marketplace.
A particularly sensitive issue in the debate over easier access to generic drugs has been that of patent infringement litigation. The FTC has noted that on seven occasions in 2006, name-brand and generic drug manufacturers have settled infringement lawsuits with agreements in which generic companies received financial compensation in return for delaying the entry of their products. Presently, the FTC is charged with examining agreements between the parties of a patent infringement settlement (concerning pharmaceuticals) to prevent unlawful, anticompetitive practices from being established.
Commissioner Leibowitz also stated that the FTC intends to study the effects of approved generic medicines on the U.S. pharmaceutical market.
More about the FTC's responsibilities concerning anticompetitive practices can be viewed by visiting the Web site of its Bureau of Competition.
Source: IP-Health [Online]. July 20, 2006. FTC Testifies on Barriers to the Entry of Generic Drugs. Vol. 1(2108).
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