Kathleen Sebelius, secretary of the U.S. Department of Health and Human Services, said the legislation, which passed both the House and Senate with overwhelming bipartisan majorities, should help speed safe and effective medical products to patients and maintain our nation's role as a leader in biomedical innovation.
"This legislation will drive timely review of new innovator drugs and medical devices, implement the program proposed in the 2013 President's Budget to accelerate approval of lower-cost generic drugs, and fund the new approval pathway for biosimilar biologics -- medical product -- created by the Affordable Care Act," Sebelius said in a statement. "The legislation also enhances the tools available to the FDA to combat drug shortages by requiring manufacturers of certain drugs to notify the FDA when they experience circumstances that could lead to a potential drug shortage."
Provisions in the legislation will help enhance the safety of the drug supply chain in an increasingly globalized market, increase incentives for the development of new antibiotics, renew mechanisms to ensure children's medicines are appropriately tested and labeled, and expedite development and review of certain drugs for the treatment of serious or life-threatening diseases and conditions, Sebelius said.
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