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Full-Text Articles in Law
Aids Activists, Fda Regulation, And The Amendment Of America's Drug Constitution, Lewis Grossman
Aids Activists, Fda Regulation, And The Amendment Of America's Drug Constitution, Lewis Grossman
Articles in Law Reviews & Other Academic Journals
This Article explores how AIDS activists, desperate for access to potentially life-saving pharmaceuticals, permanently transformed America’s “drug constitution.” Their advocacy altered the FDA’s interpretation and application of the federal Food, Drug, and Cosmetic Act (FDCA) so as to expedite the availability of new, unproven drugs for critical illnesses, thus enhancing individual patients’ autonomy to make therapeutic choices without government interference.The FDCA is more than simple set of instructions to a federal agency — it is a source of vitally important and deeply entrenched institutional and normative frameworks. Like major civil rights, antitrust, and environmental statutes, the FDCA should be viewed …
Fda And The Rise Of The Empowered Consumer, Lewis Grossman
Fda And The Rise Of The Empowered Consumer, Lewis Grossman
Articles in Law Reviews & Other Academic Journals
This Article traces the still-evolving view of consumers of FDA-regulated products as capable, rational, and rights-bearing decision makers. It also examines the corresponding diminution of FDA’s role as a paternalistic gatekeeper collaborating with medical and scientific experts to prevent products and manufacturer-provided information from reaching the public. Compared with their 1960s counterparts, today’s consumers of food and drugs have far greater freedom to make unmediated choices among a wider variety of products, guided by a relative deluge of labeling and advertising information. Moreover, food and drug regulation, once the exclusive domain of bureaucrats and experts, has become a focus of …