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Articles 1 - 11 of 11
Full-Text Articles in Health Law and Policy
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.
Will Courts Allow States To Regulate Drug Prices?, Christopher Robertson
Will Courts Allow States To Regulate Drug Prices?, Christopher Robertson
Faculty Scholarship
Pharmaceuticals are consuming increasingly large portions of U.S. state budgets, and high prices are preventing patients from getting, and adhering to, essential medicines. In mid-May 2018, President Donald Trump announced a heavily hyped but relatively modest federal plan to bring down drug prices. Meanwhile, several states are moving forward with their own solutions, and Maryland’s approach is particularly ambitious. In 2017, responding to notorious cases such as the 5000% increase in the cost of Daraprim (pyrimethamine) and the 10-fold increase in the cost of EpiPens (epinephrine auto-injectors), Maryland enacted a statute that prohibits manufacturers from “price gouging” on any “essential …
Drug Approval In A Learning Health System, W. Nicholson Price
Drug Approval In A Learning Health System, W. Nicholson Price
Articles
The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …
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 …
On Drugs: Preemption, Presumption, And Remedy, Elizabeth Mccuskey
On Drugs: Preemption, Presumption, And Remedy, Elizabeth Mccuskey
Faculty Scholarship
This essay explores the role of litigation in drug safety regulation and the role of drug safety regulation in litigation, exemplified by the 2017 National Health Law Moot Court Problem. Using the example of failure-to-update claims against generic drug manufacturers, this essay argues that pharmaceutical preemption doctrine would benefit from a tailored application of the presumption against preemption. It proposes a presumption that Congress does not intend to displace historic state remedies for injury without clearly saying so, focusing on the role of remedy to account for the evolving overlap in federal and state police powers over health and to …
Informing Consent: Medical Malpractice And The Criminalization Of Pregnancy, Laura Beth Cohen
Informing Consent: Medical Malpractice And The Criminalization Of Pregnancy, Laura Beth Cohen
Michigan Law Review
Since the early 1990s, jurisdictions around the country have been using civil child abuse laws to penalize women for using illicit drugs during their pregnancies. Using civil child abuse laws in this way infringes on pregnant women’s civil rights and deters them from seeking prenatal care. Child Protective Services agencies are key players in this system. Women often become entangled with the Child Protective Services system through their health care providers. Providers will drug test pregnant women without first alerting them to the potential negative consequences stemming from a positive drug test. Doing so is a breach of these providers’ …
Improving Generic Drug Approval At The Fda, Kathleen Craddock
Improving Generic Drug Approval At The Fda, Kathleen Craddock
Michigan Journal of Environmental & Administrative Law
Generic drugs are the store-brand cereal of the drug world. While they lack the vibrant colors of and exciting commercials behind name brands, generics are still effective. Most importantly, for some people, they make the difference between accessing essential treatment and going without. Getting generics to market as quickly as possible means fewer people will cut pills in half or skip doses to save money, which also saves billions of dollars across the U.S. health system. Because a new generic does not offer lifesaving changes for people with rare or complicated diseases, generics lack the “cultural capture of rhetoric about …
Trying And Dying: Are Some Wishes At The End Of Life Better Than Others?, Oliver J. Kim
Trying And Dying: Are Some Wishes At The End Of Life Better Than Others?, Oliver J. Kim
Dalhousie Law Journal
In the United States, efforts to create a "rightto try," or to provide access for the terminally ill to try experimental drugs, have seen overwhelming success in passing state legislatures. This success provided the foundation for advocates' long-term goal of a federal right to try. Yet proposals ranging from very modest advance-care-planning consultations to the "rightto die,"or medical aid in dying, face steep political challenges despite seeming public support. This paper discusses the legal underpinnings of both "rights" and the current political and policy debate over each. More often than not, these "rights" are grantedthrough legislation rather than judicial decisions, …
Innovative Contracting For Pharmaceuticals And Medicaid’S Best-Price Rule, Nicholas Bagley
Innovative Contracting For Pharmaceuticals And Medicaid’S Best-Price Rule, Nicholas Bagley
Articles
In recent years, drug manufacturers and private payers have expressed interest in novel pricing models that more closely link a drug’s price to its value. Indication-based pricing, outcome-based pricing, drug licenses, and drug mortgages have all been discussed as alternatives to paying strictly for volume. Manufacturers and payers have complained, however, that Medicaid’s “best-price rule” inhibits their ability to enter into these newpricing arrangements. This article examines the best-price rule and assesses to what extent, if any, it might frustrate the goal of paying for value. We conclude that the best-price rule is not as serious a problem as it …
Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams
Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams
Michigan Law Review
The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …
Cancer's Ip, Jacob S. Sherkow
Cancer's Ip, Jacob S. Sherkow
Articles & Chapters
The state of publicly funded science is in peril. Instead, new biomedical research efforts — in particular, the recent funding of a “Cancer Moonshot” — have focused on employing public-private partnerships, joint ventures between private industry and public agencies, as being more politically palatable. Yet, public-private partnerships like the Cancer Moonshot center on the production of public goods: scientific information. Using private incentives in this context presents numerous puzzles for both intellectual property law and information policy. This Article examines whether—and to what extent — intellectual property and information policy can be appropriately tailored to the goals of public-private partnerships. …