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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