US FTC to subpoena 100 firms on generics

The US Federal Trade Commission says it will shortly issue specialorders to about 100 drug companies (30 brand-name firms and 70 generics makers), after having been cleared by the Office of Management and Budget to conduct a study of US generic drug competition. The companies will have 60 days in which to respond to the special orders, it says.

The study should enable the agency to provide a more complete picture of how generic drug competition has developed under the Drug Price Competition and Patent Term Restoration Act of 1984 (Waxman-Hatch: see story alongside), it says, it has already taken enforcement action against alleged anticompetitive agreements whose operation depended in part on provisions of the Act (Marketletter April 9).

The investigation should shed light on matters such as whether the agreements which the FTC has found so far are isolated instances or more typical, says the agency. It should also illustrate whether particular provisions of the Act have operated appropriately to balance the legitimate interests of both branded firms in protection of their intellectual property and of generics makers in providing competition, or whether they have instead unintentionally enabled anticompetitive strategies that delay or deter market entry by generic drugs, it adds.