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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

role in developing and negotiating a comprehensive user fee program for generic drugs ("GDUFA"), along with our colleagues across the generic and active pharmaceutical ingredient industries. Through GDUFA, the generic industry, which accounts for 78% of all prescriptions dispensed in the U.S., has stepped up to the plate to help provide FDA with resources to address the industry-wide challenges caused by the global drug supply and the corresponding increase in FDA's workload. Through GDUFA, the generic industry will provide FDA with approximately $1.5 billion in new funding over the next five years. In return, FDA has agreed to more timely review of generic drug applications, increased transparency, and biennial Good Manufacturing Practice (GMP) surveillance inspections of all generic finished dosage form ("FDF") and active pharmaceutical ingredient ("API") manufacturers– both foreign and domestic – on a risk adjusted basis.[3]"

"However, for GDUFA to truly be successful and to achieve the lasting change that we at Mylan and those across our industry wish to see, the currently outdated U.S. law [the Federal Food, Drug and Cosmetic Act of 1938 ("FDCA")] must  be amended to reflect the 21st century needs of FDA in regulating the nation's global drug supply. For example, current law requires that U.S.-based manufacturers be inspected by FDA every two years, but does not require the same of foreign manufacturers. This significant disparity in the degree of FDA oversight creates an unlevel playing field by reducing the ability of American businesses to compete since complying with quality systems and FDA regulations represents approximately 25% of a drug manufacturer's operating costs.[4]  U.S.-based facilities participating in both the U.S. and global pharmaceutical market should not be competitively disadvantaged and effectively encouraged to move jobs outside the U.S. as a result of an antiquated law that is impeding FDA from carrying out
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SOURCE Mylan Inc.
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