The Coalition for Competitive Pharmaceutical Market (CCPM) is one of the many groups that applauded the bipartisan introduction of the Access to Life Saving-Medicine Act of 2007, which aims to bring safe, effective, and more affordable biogeneric drugs to Americans. CCPM is an organization of large national employers, health plans, pharmacy benefit managers, chain pharmacies, generic drug manufacturers and others committed to improving consumer access to high quality, affordable generic medicines and promoting a vigorous, competitive prescription drug market. CCPM chair Annette Guarisco said, "CCPM endorses this legislation as a safe, science-based approach that appropriately leaves full discretion to the FDA to determine the safety and efficacy of biogenerics." GPhA also applauded the proposed legislation with the following statement, "The Access to Life-Saving Medicine Act will create a safe, clear, and efficient abbreviated FDA approval pathway so patients can have timely access to biogenerics." The legislation was sponsored by Reps. Henry Waxman (D, Calif.), Jo Ann Emerson (R, Mo.), Frank Pallone (D, N.J.), and Rahm Emanuel (D, Ill.) and Sens. Charles Schumer (D, N.Y.), Hillary Clinton (D, N.Y.), Debbie Stabenow (D, Miss.), Patrick Leahy (D, Vt.), Susan Collins (R, Maine), and David Vitter (R, La.).
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.