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Articles 1 - 3 of 3
Full-Text Articles in Law
Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang
Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang
University of Michigan Journal of Law Reform
Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …
Investigating 40 C.F.R. Sec. 124.55(B): State-Court Review Of Npdes Permit Certifications, Tad Macfarlan
Investigating 40 C.F.R. Sec. 124.55(B): State-Court Review Of Npdes Permit Certifications, Tad Macfarlan
University of Michigan Journal of Law Reform
This Note investigates the wisdom and validity of 40 CER. § 124.55(b), a Clean Water Act regulation promulgated by the U.S. Environmental Protection Agency (EPA) as part of the National Pollution Discharge Elimination System (NPDES) permitting program. The Clean Water Act provides affected states with an opportunity to certify federally administered NDES permits before issuance by EPA. State certification is a meaningful moment in water quality regulation, and judicial review of these critical decisions takes place in state courts. Unfortunately, 40 C.ER. § 124.55(b), designed to bring certainty and finality to permit-holders, effectively removes state courts from the process of …
Environmental Deliberative Democracy And The Search For Administrative Legitimacy: A Legal, Positivism Approach, Michael Ray Harris
Environmental Deliberative Democracy And The Search For Administrative Legitimacy: A Legal, Positivism Approach, Michael Ray Harris
University of Michigan Journal of Law Reform
The failure of regulatory systems over the past two decades to lessen the environment degradation associated with modern human economic output has begun to undermine the legitimacy of environmental lawmaking in the United States and around the world. Recent scholarship suggests that reversal of this trend will require a breach of the environmental administrative apparatus by democratization of a particular kind, namely the inclusion of greater public discourse within the context of regulatory decision-making. This Article examines this claim through the lens of modern legal positivism. Legal positivism provides the tools necessary to test for and identify the specfic structural …