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Bush sets rules to bring generic drugs to market
Reuters ^ | 6/12/03

Posted on 06/12/2003 7:36:40 AM PDT by areafiftyone

WASHINGTON, June 12 (Reuters) - U.S. President George W. Bush plans to announce regulations on Thursday aimed at bringing lower-cost generic drugs to market faster in a move that courts senior citizens, a key voting bloc in next year's presidential election.

The final rules, initially proposed by Bush in October, seek to limit a drug patent holder's ability to draw out the process for bringing a generic drug to market though multiple challenges.

Legislation approved by a U.S. Senate committee on Wednesday has similar goals: stopping unfair extensions of patents on brand-name drugs that delay competition from less-expensive copycat medicines.

In addition to the rules, the White House will boost the Food and Drug Administration's budget by $13 million to speed reviews of generic drug applications.

By White House estimates, the new measures would cut prescription drug costs by more than $3 billion a year in the United States.

Bush plans to make the announcements during a speech at a New Britain, Connecticut, center for seniors.

By proposing tax cuts on dividends, prescription drug benefits for Medicare recipients and new generic drug rules, Bush hopes to shore up support from senior citizens -- a powerful political force in pivotal states like Florida.

The Senate bill generally would limit brand-name manufacturers to one 30-month extension of patent protection to resolve disputes when a generic drug maker seeks to market its version.

In the past, companies in some cases have been able to obtain multiple 30-month extensions to keep a rival product off the market.

Also, generic producers would be able to file counter-claims if a branded company sues them for violating a patent.


TOPICS: Culture/Society; Government; News/Current Events
KEYWORDS: genericdrugs; medicare

1 posted on 06/12/2003 7:36:40 AM PDT by areafiftyone
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