Health & medicine
Rule could speed up generic drug releaseBy Associated Press
© St. Petersburg Times
published June 13, 2003
WASHINGTON - Cheaper generic versions of pricey medications could reach consumers more quickly under federal rules announced Thursday - but not as quickly as the Senate hopes to speed them.
The goal is to save consumers and taxpayers billions in health care costs. The question is how far the government will challenge the brand-name drug industry to do that.
The Bush administration issued new rules to make it harder for brand-name drug companies to block generic competition.
"We will bring generic drugs to the market much more quickly, in some cases years earlier," said President Bush, estimating the changes could save $3.5-billion a year.
Under the rules, lawsuits to stall Food and Drug Administration approval of the cheaper generic could only trigger a single 30-month delay. Today, brand-name companies can file repeated patent infringement challenges that trigger multiple 30-month stays.
The new FDA rule, which takes effect Aug. 18, also forbids frivolous patents, such as those covering a drug's packaging, from being registered with the FDA and thus triggering the delay.
Generic drugs typically cost less than half the price of their brand-name counterparts, so every month that the maker of a blockbuster brand can stave off competition means big profits.
The legislation would also block other tactics that thwart generic competition - including payoffs to generic companies to keep cheaper products off the market.
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