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Mylan CEO Heather Bresch Testifies Before Congress in Support of Generic Drug User Fee Program and Urges Update of Federal Food, Drug and Cosmetic Act of 1938 to Create a Level Playing Field for Manufacturers
Date:2/9/2012

its oversight responsibilities over all players supplying the U.S. pharmaceutical market."

"Inspection parity will also benefit foreign facilities, as well as small and first-time entrants to the industry, which are currently disadvantaged by delays in gaining approval for new products – brand or generic – due to a lack of a recent inspection history, which is required before a new product can be approved."

"Mylan urges Congress to pass GDUFA, as unanimously ratified by industry, and update the FDCA. By taking these steps, we can further reduce government and taxpayer health care spending through more timely access to affordable generic medicine; ensure American competitiveness by addressing the unlevel playing field currently faced by U.S. manufacturers through inspection rates that are four times that of foreign competitors; and equip FDA with the authority it needs to carry out its mission of protecting the drug supply in today's highly globalized industry," Bresch's testimony concluded.

About Mylan

Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 150 countries and territories. The company maintains one of the industry's broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world's largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.

[1] U.S. Government Accountability Office. Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its Information on Foreign Establishments, but More Progress Is Needed (Publicati
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