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How the FDA’s Breakthrough Therapy Designation Creates a Two-Tier Drug Market — and Why the Label Does More Work Than the Clinical Data

On July 9, 2012, President Obama signed the FDA Safety and Innovation Act, Pub. L. 112-144. Buried in Section 902 is a short statutory addition to the Federal Food, Drug, and Cosmetic Act — 21 U.S.C. § 356(b) — that created something called Breakthrough Therapy Designation, or BTD. The qualifying language runs 38 words. A […]