Although the principle of personal autonomy is commonly accepted as the proper guide for health care decisions, that principle has been conspicuously absent in the area of drug regulation, where the FDA has the unquestioned power to keep drugs off the market if it deems them either unsafe or ineffective. In the difficult area of cancer drugs, undue reliance on FDA expertise has serious deleterious effects. The most conspicuous sign that its regulatory role is often counterproductive is the widespread off-label use of drugs to treat conditions in ways that have not been approved by the FDA. These uses are not undertaken by individual doctors on a whim but are subject to systematic, voluntary oversight within the profession, which works more swiftly and sensibly than the FDA itself. The clear policy recommendation is that the FDA should work hard to speed new drugs to the market given the other superior mechanisms available to collect and evaluate the information on whether, and if so how, these drugs should be used.
DAN’S [F]LAW: STATUTORY FAILURE TO ENFORCE ETHICAL BEHAVIOR IN CLINICAL DRUG TRIALS Noah Lewellen* I. INTRODUCTION Paul, a sophomore at the University of Minnesota, bursts into a lecture hall, loudly claims to see monsters sitting in the seats, and offers his services in slaying them. The police are called, and [...]
Case Comment: Bhogaita v. Altamonte
EVERY DOG CAN HAVE HIS DAY IN COURT: THE USE OF ANIMALS AS DEMONSTRATIVE EXHIBITS Kyle R. Kroll, Volume 100, Online Managing Editor In Bhogaita v. Altamonte, the Eleventh Circuit recently decided whether to allow a dog in the courtroom as a demonstrative exhibit. Although the case presented many serious [...]
Revisiting Water Bankruptcy
REVISITING WATER BANKRUPTCY IN CALIFORNIA’S FOURTH YEAR OF DROUGHT Olivia Moe, Volume 100, Managing Editor This spring, as “extreme” to “exceptional” drought stretched across most of California—indicating that a four-year streak of drought was not about to resolve itself—Governor Jerry Brown issued an unprecedented order to reduce potable urban water [...]