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Full-Text Articles in Law
Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs
Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs
Articles
Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked the Trump administration for a waiver that would, among other things, allow its Medicaid program to decline to cover costly drugs for which there is limited or inadequate evidence of clinical efficacy. By credibly threatening to exclude such drugs from coverage, Massachusetts hoped to extract price concessions and constrain the fastest-growing part of its Medicaid budget.
Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox
Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox
Michigan Telecommunications & Technology Law Review
Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common …
When And How To Defer To The Fda: Learning From Michigan's Regulatory Compliance Defense, Jason C. Miller
When And How To Defer To The Fda: Learning From Michigan's Regulatory Compliance Defense, Jason C. Miller
Michigan Telecommunications & Technology Law Review
Michigan's regulatory compliance defense properly recognizes that an FDA-approved drug carrying an FDA-approved label should not be considered defective. However, the statute's absolute immunity provides no compensation for injured parties in any circumstance, including situations where the FDA process has failed. Nevertheless, it is possible to treat the FDA's approval as significant without eliminating the possibility of all state actions against drug makers by providing a litigation back-up through state attorneys general ("AGs"). This Note examines the question of FDA approval in state tort actions in Part I, discusses Michigan's answer to that question in Part II, and offers a …
Refusal To Dispense Emergency Contraception In Washington State: An Act Of Conscience Or Unlawful Sex Discrimination?, Dana E. Blackman
Refusal To Dispense Emergency Contraception In Washington State: An Act Of Conscience Or Unlawful Sex Discrimination?, Dana E. Blackman
Michigan Journal of Gender & Law
This Article will demonstrate that a pharmacist's refusal to fill a valid prescription for emergency contraception constitutes sex discrimination and violates the WLAD. Part I explains the nature and function of emergency contraceptive pills (ECPs) as well as their role in basic health care for women and the importance of their accessibility. Part II addresses federal civil rights protections and the failure of these protections to provide relief for women facing refusals. Focusing on the WLAD, Part II also explains how state public accommodation statutes protect women from discrimination in places of public accommodation. It further sets forth the prima …
Improving Michigan's Generic Drug Law, Phyllis Greenwood Rozof
Improving Michigan's Generic Drug Law, Phyllis Greenwood Rozof
University of Michigan Journal of Law Reform
This note will describe the conditions which existed prior to enactment of the Michigan drug substitution law, will discuss the history and provisions of that legislation, and will identify certain problems which the law fails to correct.