Heather Bresch testified before Congress in support GDUFA FDCA

Heather Bresch testified before Congress in support of GDUFA and FDCA

1:36 AM, 10th February 2012
Heather Bresch testified before Congress in support of GDUFA and FDCA
Heather Bresch, CEO, Mylan.

PITTSBURGH, US: Heather Bresch, CEO, Mylan testified before the US 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.’ Mylan urged Congress to pass Generic Drug User Fee Act (GDUFA), as unanimously ratified by industry, and update the Food, Drug and Cosmetic Act (FDCA).

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

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