Bush Announces an Easing of Rules on New Generic Drugs

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http://query.nytimes.com/gst/abstract.html?res=F30B15FA345D0C708DDDAF0894DB404482

National Desk | June 13, 2003, Friday
Bush Announces an Easing of Rules on New Generic Drugs

By RICHARD W. STEVENSON (NYT) 726 words
Late Edition - Final , Section A , Page 28 , Column 1

ABSTRACT - Pres Bush announces new rules to make it easier to introduce lower-cost generic drugs, intensifying efforts on health care issues ahead of next year's election; says FDA will limit drug makers' ability to delay introduction of generics by filing multiple patent-infringement lawsuits; companies will get only one 30-month regulatory delay; Bush also directs FDA not to block generics because of patent disputes over minor matters like color of bottle; comments to audience of older people at hospital in New Britain, Conn, as Senate takes up bipartisan bill for Medicare drug coverage; Bush continues on to family weekend in Kennebunkport, where he tumbles off motorized scooter; he is not hurt; photos (M) President Bush announced new rules today that make it easier to introduce lower-cost generic versions of prescription drugs, intensifying his efforts to address health care issues ahead of next year's election.

The president, making good on a proposal he first made last year, said the Food and Drug Administration's action would limit the ability of pharmaceutical companies to delay the introduction of generic versions of prescription medicines. He said the F.D.A. rule would curtail a practice among manufacturers of brand-name drugs of delaying the introduction of generic versions by filing multiple patent-infringement lawsuits against potential competitors.



 

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