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Off-Label Innovations, David A. Simon
Off-Label Innovations, David A. Simon
Georgia Law Review
Modern medicine faces many significant problems. This Article is about two of them. The first is that approved drugs have many potential therapeutic uses that are never identified, investigated, or developed. The second is the routine practice of physicians prescribing approved drugs for unapproved uses—so-called “off-label” uses. These problems seem very different. Failure to invest in potential new uses is an innovation problem: firms lack incentives to research and develop new uses of old drugs. The problem of off-label uses, on the other hand, is one of safety and efficacy: off-label uses are risky because they are not supported by …
Agents Of Bioshield: The Fda, Emergency Use Authorizations, And Public Trust, Kirstiana Perryman
Agents Of Bioshield: The Fda, Emergency Use Authorizations, And Public Trust, Kirstiana Perryman
Georgia Law Review
The SARS-CoV-2 pandemic spurred the U.S. Food & Drug Administration (FDA) to utilize the Emergency Use Authorization (EUA) procedure more than ever before. The pandemic pushed the relatively obscure procedure into public consciousness, making it a frequent topic of discussion and debate. The EUA procedure permits the FDA Commissioner to authorize the introduction of drugs, devices, or biological products into interstate commerce for use in an actual or potential emergency. To issue an authorization, the FDA Commissioner must determine that it is “reasonable to believe,” based on the “totality of the evidence,” that the product “may be effective.” This standard …