Rep. Henry Waxman (D-CA), Sen. Charles Schumer (D-NY), and Sen. Hillary Rodham Clinton (D-NY) introduced the “Access to Life-Saving Medicines Act” last Friday. If enacted, the legislation would establish an abbreviated application process for biological products.
According to the proposed bill, a generic biological product is “comparable,” and therefore approvable in an abbreviated application “if there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity and potency of the product, based on non-clinical studies and clinical studies, as necessary.”
This page on Rep. Waxman’s website includes a press release, background on biologics, a quick summary, a bill summary, the text of the bill, and letters of support.
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NOTE: thanks to Kurt Karst for sending me the link to this material.
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