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Judge to rule on authorized generics
The Associated Press ^ | Aug. 30, 2004 | The Associated Press

Posted on 08/30/2004 12:11:26 PM PDT by Dubya

CLARKSBURG, W.VA. -- Congress left "a gaping black hole" in federal prescription drug laws by apparently failing to anticipate the advent of so-called authorized generics, a development that a federal judge said could undermine fair competition in the marketplace. U.S. District Judge Irene Keeley will probably rule today in a dispute between the U.S. Food and Drug Administration and generic drug giant Mylan Laboratories that has major financial implications for generic drug producers. Generally, the first generic company to successfully challenge a brand-name patent enjoys 180 days of marketing exclusivity, meaning its product is the only generic sold during that time. Congress created the provision as an incentive for generic companies and to get lower-cost drugs to market more quickly. Since September, however, brand makers such as Procter & Gamble Co. have been introducing authorized generics, renaming their own products and selling them through a licensed distributor. The product is the same as the brand-name drug but sells at a cheaper price.


TOPICS: Business/Economy; Constitution/Conservatism; Culture/Society; Foreign Affairs; Government; Miscellaneous; News/Current Events
KEYWORDS: authorizedgenerics; fda; genericdrugs; healthcare; prescriptiondrugs

1 posted on 08/30/2004 12:11:28 PM PDT by Dubya
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To: Dubya

"Since September, however, brand makers such as Procter & Gamble Co. have been introducing authorized generics, renaming their own products and selling them through a licensed distributor. The product is the same as the brand-name drug but sells at a cheaper price."

I say good for them. The damn generic makers don't do a thing other than sponge off the hard work and investments of the drug developers.

At least this way the big developers can regain some of their market share and re-invest some of that money into the development of new drugs.


2 posted on 08/30/2004 12:25:32 PM PDT by Bikers4Bush (Flood waters rising, heading for more conservative ground. Vote for true conservatives!)
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