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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 […]

How SEC Settlements Create Market Facts Without Proving Them

On September 12, 2023, the Securities and Exchange Commission posted a cease-and-desist order against a mid-size broker-dealer. Supervisory failures tied to customer account transfers. The firm settled. Paid $1.2 million. Consented to the order without admitting or denying the findings. That phrase — “without admitting or denying” — runs through roughly 70 percent of SEC […]