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Mylan Testifies on Authorized Generics

Heather Bresch, Mylan Laboratories Inc.'s Senior Vice President of Strategic Corporate Development testified today, July 20, 2006, before the U.S. Senate Special Committee on Aging today concerning potential solutions for authorized generics and other issues.

Pharma Live reported:

Ms. Bresch commented: "Brand pharmaceutical companies are employing multiple tactics in order to delay or block consumer access to affordable pharmaceuticals. We are pleased that a bi- partisan group of congressional leaders has taken the lead on addressing these issues, and we are confident that legislative and other measures can be implemented to restore the unique balance that existed in the United States between brand and generic pharmaceuticals."

Mylan's testimony comes on the heels of the introduction of legislation yesterday to address one of the most important issues: "authorized" generics, which are simply branded products relabeled and sold as generics during the 180-day exclusivity period Congress set aside for the first generic company that successfully invalidates a patent. Sen. John D. (Jay) Rockefeller IV, W.Va., introduced S. 3695 prohibiting authorized generics during the 180-day exclusivity period. The bill was co-sponsored by Sens. Charles E. Schumer, N.Y., and Patrick Leahy, Vt.

"Mylan has done great work in upholding the intent of Hatch-Waxman. Authorized generics should not be allowed during the 180-day period Congress intended for a true generic manufacturer to have exclusive market rights. That is why I have introduced legislation to prohibit the introduction of what are brand name drugs-in-disguise during the 180 days," said Sen. John D. (Jay) Rockefeller IV.

Ms. Bresch commented: "We applaud Sens. Rockefeller, Schumer and Leahy for their leadership on this issue. A soon to be released independent study demonstrates the true facts on authorized generics: consumers do not realize any additional savings from authorized generics, and they put billions of dollars of future healthcare savings at risk."

Ms. Bresch's full testimony is available here.

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