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US pushes bill to promote competitive presence of generic drug manft. March 7, 2007

Posted by mais in Drugs, USA.
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The bipartisan Preserve Access to Affordable Generics Act (S. 316) would prohibit brand-name drug companies from exploiting a loophole in the Hatch-Waxman Act to pay generic drug companies to delay entry of new generic medicines into the market.

The bill brought by Senator Patrick Leahy, (D-Vt.), and supported by Senators Herb Kohl (D-Wisc.), Chuck Grassley (R-Iowa), Russ Feingold (D-Wisc.), and Charles Schumer (D-NY).

The bill aims to end the trend of anti-competitive agreements between brand name pharmaceutical companies and generic companies to delay entry of affordable generics into the market.

Today, the law can’t stop the original patent holder from launching an “authorized generic” through a subsidiary or a third party. Sales of an authorized generic during the exclusivity period can cut the generic maker’s profits by 59 percent, according to research by Merrill Lynch analyst Greg Gilbert.

On the other hand Branded drug companies are lobbying with Bush administration to impose a new fees for the drug application filed by generic drug companies

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