Generic Drug Offerings Studied

      WASHINGTON (AP) - The Federal Trade Commission wants to examine the records of pharmaceutical companies to find whether they keep lower-cost generic drugs off the market.

      The proposed study would examine whether 30 makers of brand-name drugs and 60 companies that make generics have delayed marketing of the cheaper drugs by ``anti-competitive agreements'' or other strategies.

      The FTC has already filed complaints against four drug-makers for allegedly entering into agreements that effectively stopped generic forms of two brand-name drugs from coming to market. The complaints involve Hytrin, used to treat high blood pressure and prostate enlargement, and Cardizem-CD, a widely prescribed drug for treatment of hypertension and chest pain.

      Over the next five years, drugs with nearly $20 billion in annual sales in the United States will go off-patent, said FTC Chairman Robert Pitofsky.

      While the end of the patents means that pharmaceutical companies stand to lose profits on brand-name drugs, it also allows lower-cost generics onto the market.

      The FTC proposes to look into the records of 30 ``innovator'' drug companies and 60 makers of generics to find whether they used agreements to delay drug competition. The commission must first seek public comment on the planned study.

      A spokeswoman for the Pharmaceutical Research and Manufacturers of America said the trade group is ``confident that any balanced study by the FTC will find the brand-name industry''s practices are beneficial to patients.''

      Under a 1994 law, a drug company can seek approval from the Food and Drug Administration to market a generic drug before the expiration of the brand name''s patent. The act allows the patent holder to bring a patent-infringement suit, stalling FDA approval for 30 months, or until litigation is complete. The first company to file an application for the generic drug then has 180 days to market the drug exclusively.

      The study announced Wednesday would look into the 30-month provision, as well as the 180-day marketing provision.

      On the Net:

      Federal Trade Commission site: http://www.ftc.gov

     

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