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

PITTSBURGH, Feb. 9, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) CEO Heather Bresch today testified before the U.S. House of Representatives Energy and Commerce Committee at a hearing hosted by the subcommittee on Health entitled "Review of the Proposed Generic Drug and Biosimilars User Fees and Further Examination of Drug Shortages."

In her testimony, Bresch commented: "Every consumer should have the peace of mind in knowing that every prescription, brand or generic, dispensed in the United States, is held to the same standard of quality regardless of whether the product or its ingredients originated in the U.S. or outside its borders. With a mission to protect and promote the public health, the U.S. Food and Drug Administration ("FDA") has a critical responsibility, along with industry, to ensure the safety, efficacy and security of the U.S. drug supply. Unfortunately, FDA is still operating as a domestic agency, under a 1938 law that has remained largely unchanged despite globalization of the industry, which has left it without the resources or legal authority to regulate the global drug supply that now serves the U.S. market. Just as the pharmaceutical industry has become global, in order to meet its mission, so too must FDA."

Drug products, both branded and generic, originate in factories all over the world, moving into the American marketplace through supply chains that can involve numerous players. It is estimated that up to 40% of finished drugs consumed by U.S. patients are manufactured abroad and 80% of the active ingredients and bulk chemicals used in drugs come from foreign countries.[1]  According to FDA, the number of foreign drug facilities supplying the U.S. has grown by 185% between 2001 and 2008, while at the same time FDA inspection rates have decreased by nearly 57%.[2]