St. Petersburg Times Online: World&Nation
Place an Ad Calendars Classified Forums Sports Weather
Print storySubscribe to the Times

Health & medicine

Rule could speed up generic drug release

By 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.

Back to World & National news
Back to Top

© 2006 • All Rights Reserved • Tampa Bay Times
490 First Avenue South • St. Petersburg, FL 33701 • 727-893-8111
Special Links
Susan Taylor Martin

From the Times wire desk
  • In Mideast, each side vows to kill the other
  • Senate supports check of gas, oil
  • Students charged years after dorm fire
  • This time, bishops avoid the limelight
  • Tehran protests reach 3rd day

  • Columbia
  • Bolt fragment may threaten space shuttles

  • Column
  • The dignity and sensitivity? Not acting; it was all Peck

  • Health & medicine
  • Monkeypox patient may have infected Wis. nurse
  • Rule could speed up generic drug release
  • Medicare drug plan closer to final vote
  • No proof vitamins help heart

  • Iraq
  • CIA says it attempted to debunk arms claim
  • Soldiers go door to door after Hussein loyalists

  • Nation in brief
  • Immigrants more likely to drop out

  • Recall
  • Country Pride Fresh Chicken

  • World in brief
  • Saudi Arabia tells of antiterror moves

  • From the AP
    national wire
    From the AP
    world desk