Federal Trade Commission To Investigate Authorized Generic Medications
The Federal Trade Commission on Wednesday told Congress that it will study pharmaceutical companies' practice of launching generic versions of their own brand-name drugs when patents expire or are challenged successfully in court, the Newark Star-Ledger reports.
The practice of selling such drugs -- known as authorized or licensed generics -- has been criticized by generic pharmaceutical companies, who claim it undermines competition. Under the Hatch-Waxman Act, designed to make it easier for generic drugs to reach the market, the first manufacturer to put a generic version of a brand-name drug on the market is supposed to receive 180 days of exclusive sales.
Senate Finance Committee Chair Chuck Grassley (R-Iowa) and Sens. Patrick Leahy (D-Vt.) and Jay Rockefeller (D-W.Va.) requested the FTC inquiry in May (Jordan, Newark Star-Ledger, 11/10). Grassley in a release said, "I'm concerned that the practice of authorized generics might give reason for the generic industry to stay away from investing in generic drugs as well as possibly jeopardize the vitality of the industry in the long term" (CQ HealthBeat, 11/9).
FTC Chair Deborah Platt Majoras said the commission would employ its "full investigatory powers," including the use of subpoenas, in its inquiry.
Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association, in a statement said, "Authorized generics could lead to fewer generic applications and fewer products on the market in the future, which ultimately would be bad for consumers."
Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America, said brand-name drug companies were "always free" to sell their drugs under multiple names or on the generic market and added that licensed generics gave consumers "a broader range of choices" (Newark Star-Ledger, 11/10).