FTC To Limit Generic Drug Delays

Miss Aruba 2007, Carolina Raven, poses for photographers on the runway clad in traditional dress on Reforma Avenue in Mexico City, Sunday, May 20, 2007. Raven will compete for the title of Miss Universe 2007 during the 56th annual Miss Universe competition in Mexico City, on Monday, May 28, 2007.
The Federal Trade Commission wants to limit the ability of drug companies to delay the marketing of generic competitors and to require the firms to disclose agreements covering the sales of generic drugs.

"The commission's recommendations today are designed to accomplish two goals: to facilitate generic entry and to maintain appropriate incentives for the development of new drug products," said FTC chairman Timothy J. Muris.

American consumers benefit from both innovation in drugs and the marketing of generic versions, he noted.

The proposals stem from a study of whether pharmaceutical companies keep lower-cost generics off the market.

When a generic is approved for sale by the Food and Drug Administration, the first company to market it is allowed 180 days of sales before another competitor is approved. The FTC has expressed concerns that brand-name companies either make payments to the generic company to delay marketing, or make some other agreement to "park" those sales for a time.

The FTC has filed complaints against drug-makers for allegedly entering into agreements that effectively stopped generic forms of brand-name drugs from coming to market.

However, in one case earlier this month, an administrative judge dismissed the agency's complaint that alleged pharmaceutical giant Schering-Plough Corp. conspired with Upsher-Smith Laboratories to keep a generic drug off the market.