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Full-Text Articles in Law
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 …
New Dtca Guidance — Enough To Empower Consumers?, Christopher Robertson
New Dtca Guidance — Enough To Empower Consumers?, Christopher Robertson
Faculty Scholarship
As one of only two countries that permit direct-to-consumer advertising (DTCA) of pharmaceuticals, the United States tasks the Food and Drug Administration (FDA) with regulating that advertising to ensure that it doesn't mislead consumers. When a drug maker publishes or broadcasts a claim that its drug has benefits in a particular disease, the FDA requires it to include information on the product's risks as well. Since it's not feasible for companies to include all the important information about their products in a television ad, the FDA requires them to refer viewers to more complete information, such as that in a …
Consolidating Pharmaceutical Regulation Down Under: Policy Options And Practical Realities, Frances H. Miller
Consolidating Pharmaceutical Regulation Down Under: Policy Options And Practical Realities, Frances H. Miller
Faculty Scholarship
Pharmaceutical regulatory agencies struggle worldwide to maintain public trust these days. Drug safety issues proliferate,' the costs of lharmaceuticals take increasingly larger shares of most countries' health service spending, and conflicts of interest afflicting the drug approval and marketing processes capture more and more public attention. The Australian and New Zealand governments are keenly aware of these problems, and have been attempting to forge a regulatory alliance to combine their respective pharmaceutical regulatory agencies, Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe), into the pending Trans Tasman Therapeutic Products Authority (ANZTPA, or TPA). …
Pharmacogenomics, Genetic Tests, And Patent-Based Incentives, Michael J. Meurer
Pharmacogenomics, Genetic Tests, And Patent-Based Incentives, Michael J. Meurer
Faculty Scholarship
Pharmacogenomics promises to revolutionize medicine by using genetic information to guide drug therapy. Genetic tests will help doctors improve drug safety and efficacy by better matching patients and drugs. This Article evaluates the effectiveness of patent-based incentives to create genetic tests, and the optimal mix of public and private sector pharmacogenomic R&D. Drug patent owners have a strong incentive to develop genetic tests that predict adverse drug reactions and allow them to market drugs that otherwise would be shelved. Incentives are also strong for genetic tests that are created as part of the drug development process. Incentives tend to be …