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Full-Text Articles in Law
Doctors, Patients, And Pills--A System Popping Under Too Much Physician Discretion? A Law-Policy Prescription To Make Drug Approval More Meaningful In The Delivery Of Health Care, Michael J. Malinowski
Doctors, Patients, And Pills--A System Popping Under Too Much Physician Discretion? A Law-Policy Prescription To Make Drug Approval More Meaningful In The Delivery Of Health Care, Michael J. Malinowski
Journal Articles
This article challenges the scope of physician discretion to engage in off-label use of prescription drugs. The discretion to prescribe dimensions beyond the clinical research that puts new drugs on pharmacy shelves has been shaped by two historic influences: a legacy of physician paternalism, solidarity, autonomy, and self-determination that predates the contemporary commercialization of medicine by more than half a century, and regulatory necessity due to the limits of science and innate crudeness of pharmaceuticals prior to the genomics revolution (drug development and delivery based upon genetic expression). Although both factors have changed immensely, the standard for drug approval has …
Leaving The Fda Behind: Pharmaceutical Outsourcing And Drug Safety, Chenglin Liu
Leaving The Fda Behind: Pharmaceutical Outsourcing And Drug Safety, Chenglin Liu
Faculty Articles
During the 2008 heparin crisis, a tainted blood-thinning drug imported from China caused the deaths of at least eighty people in the United States. However, despite the Food and Drug Administration’s (“FDA”) reactive measures, the American regulatory framework for drug safety remains largely unchanged. Currently, about 80% of active pharmaceutical ingredients, 40% of finished drugs, and 50% of all medical devices used in the United States are imported from over 100 countries. With the growth of product outsourcing, pharmaceutical companies in the United States have stopped manufacturing many essential medicines. Nevertheless, the FDA’s foreign inspections have lagged. It would take …
A Randomized Study Of How Physicians Interpret Research Funding Disclosures, Christopher Robertson
A Randomized Study Of How Physicians Interpret Research Funding Disclosures, Christopher Robertson
Faculty Scholarship
The effects of clinical-trial funding on the interpretation of trial results are poorly understood. We examined how such support affects physicians’ reactions to trials with a high, medium, or low level of methodologic rigor.
Regulating Compounding Pharmacies After Necc, Kevin Outterson
Regulating Compounding Pharmacies After Necc, Kevin Outterson
Faculty Scholarship
Food and Drug Administration (FDA) rules are often forged in crisis. After the 1937 sulfanilamide disaster that killed more than 100 people, Congress passed the Food, Drug, and Cosmetic Act (FDCA),requiring drugs to be safe and properly labeled. In 1962, a requirement was introduced for proof of drug efficacy through “adequate and well-controlled investigations,” partly in response to the thalidomide tragedy. Rules protecting human-research subjects owe a debt to Tuskegee and Nuremberg.