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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.
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 …
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 …
Preparing For The Apocalypse: A Multi-Prong Proposal To Develop Countermeasures For Biological, Chemical, Radiological, And Nuclear Threats, Constance E. Bagley, Anat Alon-Beck
Preparing For The Apocalypse: A Multi-Prong Proposal To Develop Countermeasures For Biological, Chemical, Radiological, And Nuclear Threats, Constance E. Bagley, Anat Alon-Beck
Faculty Publications
The false alarm of an Hawaiian nuclear attack in January 2018 is an example of the lack of U.S. preparedness for attacks using nuclear and other weapons of mass destruction. To address such threats, this Article proposes the establishment of a nation-wide integrated defense of health countermeasures initiative (“DHCI”), which is a multi-prong program to create a defensive triad comprising government, private industry, and academia to develop countermeasures for health threats posed by biological, chemical, radiological, and nuclear (“BCRN”) attacks. Key elements of our multi-faceted proposal include the use of the government’s Other Transaction Authority to simplify procurement arrangements, the …
Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen
Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen
Articles
In 2015, one of us published a peer-reviewed study, together with colleagues at the University of California, San Francisco, replicating prior research from the US Food and Drug Administration (FDA) detecting a designer stimulant, β-methylphenylethylamine, in sports, weight loss, and “cognitive function” supplements sold in the United States. The confirmatory study prompted the FDA to take enforcement action against companies selling the stimulant as a dietary ingredient. One of the companies that received an FDA warning letter sued the study’s authors for $200 million in damages for libel, claiming, without supporting scientific evidence, that multiple statements in the article were …
How Dreamland Colored My Summer Vacation And Thinking About The Opioid Epidemic, Elizabeth Leonard
How Dreamland Colored My Summer Vacation And Thinking About The Opioid Epidemic, Elizabeth Leonard
Scholarly Works
Book Review of Dreamland: The True Tale of America’s Opiate Epidemic by Sam Quinones,(2018).
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. …