Pharmaceutical Federalism,
2017
Georgia State University College of Law
Pharmaceutical Federalism, Patricia J. Zettler
Faculty Publications By Year
There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013 Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …
Germ-Line Gene Editing And Congressional Reaction In Context: Learning From Almost 50 Years Of Congressional Reactions To Biomedical Breakthroughs,
2017
Harvard Law School
Germ-Line Gene Editing And Congressional Reaction In Context: Learning From Almost 50 Years Of Congressional Reactions To Biomedical Breakthroughs, Russell A. Spivak, J.D., I. Glenn Cohen, J.D., Eli Y. Adashi, M.D., M.S.
Journal of Law and Health
On December 18, 2015, President Obama signed into law a policy rider forestalling the therapeutic modification of the human germ line. The rider, motivated by the science’s potential unethical ends, is only the most recent instance in which the legislature cut short the ongoing national conversation on the acceptability of a developing science. This essay offers historical perspective on what bills were proposed and passed surrounding four other then-developing scientific breakthroughs—Recombinant DNA, in vitro fertilization, Cloning, Stem Cells—to better analyze how Congress is, and should, regulate this exciting and promising science.
Circling The Drain: Regulating Nutrient Pollution From Agricultural Sources,
2017
Cleveland-Marshall College of Law, Cleveland State University
Circling The Drain: Regulating Nutrient Pollution From Agricultural Sources, William Gutermuth
Journal of Law and Health
The 2014 Toledo, Ohio tap water ban has, at least temporarily, put a spotlight on United States water supplies. Consequently, many Americans have begun to take a closer look at the quality of the fresh water bodies being used to supply tap water to their homes. Therefore, this Note analyzes the problems currently threatening the lakes, rivers, and other surface waters that are the source of fresh drinking water for huge populations in the United States. Part II examines the problem of nutrient pollution and explains the harmful effects it has on human health. Part III provides an overview of …
Criminalizing Pregnancy,
2017
University of Kentucky
Criminalizing Pregnancy, Cortney Lollar
Indiana Law Journal
The state of Tennessee arrested a woman two days after she gave birth and charged her with assault of her newborn child based on her use of narcotics during her preg-nancy. Tennessee’s 2014 assault statute was the first to explicitly criminalize the use of drugs by a pregnant woman. But this law, along with others like it being considered by legislatures across the country, is only the most recent manifestation of a long history of using criminal law to punish poor mothers and mothers of color for their behavior while pregnant. The purported motivation for such laws is the harm …
The Doctor Requirement: Griswold, Privacy, And At-Home Reproductive Care,
2017
University of Missouri - Kansas City, School of Law
The Doctor Requirement: Griswold, Privacy, And At-Home Reproductive Care, Yvonne F. Lindgren
Faculty Works
Supreme Court privacy jurisprudence has traditionally offered greater protection to activities when exercised within the home. This is true in common law as well as across a broad range of constitutional claims. For example, common law privacy identifies the home as a location of solitude and repose, often conceptualized as the “right to be let alone.” Speech, or the right to be free of unwanted messages, is enhanced when the claimant is within the confines of her or his home. Fourth Amendment protections against search and seizure and the notion of the reasonable expectation of privacy are enhanced when the …
Supporting Mothers With Mental Illness: Postpartum Mental Health Service Linkage As A Matter Of Public Health And Child Welfare Policy,
2017
Drexel University
Supporting Mothers With Mental Illness: Postpartum Mental Health Service Linkage As A Matter Of Public Health And Child Welfare Policy, Jesse Krohn, Msed, Jd, Meredith Matone, Drph, Mhs
Journal of Law and Health
Through our work in youth advocacy as, respectively, legal and public health professionals, we are all too aware of the high levels of health care fragmentation experienced during pregnancy and postpartum by poor, young mothers of color. Meredith Matone’s research highlights the heightened risk of fragmentation for girls with histories of child welfare involvement. For example, she found that 66.7% of young mothers who had resided in out-of-home placements and who had taken antipsychotic medication prior to becoming pregnant failed to fill prescriptions for antipsychotics in their first postpartum year. Put another way, two-thirds of these vulnerable young mothers—a far …
Analysis Of The Proposed Tpp-Related Patent Linkage System In Taiwan,
2017
National Chengchi University
Analysis Of The Proposed Tpp-Related Patent Linkage System In Taiwan, Ping-Hsun Chen
Journal of Law and Health
The Trans-Pacific Partnership (TPP) Agreement mandates member states to implement a patent linkage system vested in Article 18.53. To successfully join the TPP Agreement, Taiwan has begun the legislation of a patent linkage system by proposing an amendment for the Pharmaceutical Affairs Act. Article 18.53 requires a member either to adopt a notification mechanism under Paragraph 1 or to stay the issuance of marketing approval under Paragraph 2. But, Taiwan’s proposal includes both measures. Taiwan’s patent linkage system allows a pioneer drug company to register patents claiming (a) a material, (b) a combination or formula, or (c) pharmaceutical use. The …
Weird Science: Frankenstein Foods And States As Laboratories Of Democracy,
2017
Cleveland-Marshall College of Law, Cleveland State University
Weird Science: Frankenstein Foods And States As Laboratories Of Democracy, Jennifer Mcgee
Journal of Law and Health
The National Bioengineered Food Disclosure Standard (the 'National Standard') was signed into law July 29, 2016. This Article analyzes the National Standard and posits that Vermont’s Act 120 was a more effective labeling law because it safeguarded consumer sovereignty. The State regulatory scheme in place prior to the passage of the National Standard satisfied consumer demand for disclosure while allowing for necessary experimentation with GMO labeling. Part I provides an overview of the current federal scheme regulating GMOs. Part II analyzes of the conflict surrounding GMOs and labeling. Given that analysis, Part III compares the disclosure requirement of the National …
Trading Safety For Innovation And Access: An Empirical Evaluation Of The Fda’S Premarket Approval Process,
2017
Brigham Young University Law School
Trading Safety For Innovation And Access: An Empirical Evaluation Of The Fda’S Premarket Approval Process, George Horvath
BYU Law Review
Congress created the premarket approval process (PMA) to provide a rigorous safety evaluation of high-risk medical devices before they may be sold on the U.S. market. Evaluating a PMA application requires the Food and Drug Administration (FDA) to conduct a lengthy, complex, and costly assessment of the extensive data a manufacturer must submit. But other policy concerns, notably a fear of hampering innovation and a desire to assure timely access to new technologies, have led Congress to relax some of the rigorous data requirements the PMA process imposes on manufacturers. Congress mandates that the FDA employ the “least burdensome” approach …
It Can't Wait: Exposing The Connections Between Forms Of Sexual Exploitation,
2017
National Center on Sexual Exploitation
It Can't Wait: Exposing The Connections Between Forms Of Sexual Exploitation, Dawn Hawkins
Dignity: A Journal of Analysis of Exploitation and Violence
No abstract provided.
The Polarization Of Reproductive And Parental Decision-Making,
2017
American University Washington College of Law
The Polarization Of Reproductive And Parental Decision-Making, Jamie Abrams
Scholarly Articles in Law Reviews & Journals
Women’s abortion decision-making and parental decision-making in child rearing are constructed as polarized methods of decision-making. Women’s abortion decision-making is understood as myopic and individualistic. Parental decision-making is understood as sacrificial and selfless. This polarization leaves reproductive decision-making isolated, marginalized, and vulnerable while parental decision-making is essentialized, protected, and revered. Both framings are inaccurate and problematic. A unified family decision-making framework that aligns abortion decision-making and parental decision-making reveals that both forms of decision-making are more multi-dimensional, relational, and family-centered than currently understood. This article exposes the ground to be gained by crossing longstanding boundaries in family law and reproductive …
Networked Medical Devices: Finding A Legislative Solution To Guide Healthcare Into The Future,
2017
Seattle University School of Law
Networked Medical Devices: Finding A Legislative Solution To Guide Healthcare Into The Future, Louiza Dudin
Seattle University Law Review
This article discusses: (I) the current legal approaches to addressing cybersecurity in general, (II) the shortcomings of current legal approaches, (III) a proposal for legislation to narrow the scope of the Medical Device Amendments (MDA) preemption clause, and (IV) the benefits and shortcomings of the proposed legislation.
Yours, Mine, Or Ours: Resolving Frozen Embryo Disputes Through Genetics,
2017
Seattle University School of Law
Yours, Mine, Or Ours: Resolving Frozen Embryo Disputes Through Genetics, Carinne Jaeger
Seattle University Law Review
Part I of this Note provides some background on the current frameworks being used by courts in dual-progenitor disputes, while Part II presents the only two cases to deal with sole-genetic progenitor disputes and details how the courts conducted their analyses. Part III explains how courts establish legal parentage and how these legal parentage standards apply to frozen embryo disputes, specifically ones that involve only one genetic progenitor. Part IV proposes a new genetic framework to assist in the resolution of these issues. This Note concludes with a recommendation for future legislative intervention to aid in the widespread and uniform …
"Playing God?": An Examination Of The Legality Of Crispr Germline Editing Technology Under The Current International Regulatory Scheme And The Universal Declaration On The Human Genome And Human Rights,
2017
University of Georgia School of Law
"Playing God?": An Examination Of The Legality Of Crispr Germline Editing Technology Under The Current International Regulatory Scheme And The Universal Declaration On The Human Genome And Human Rights, Brooke Elizabeth Hrouda
Georgia Journal of International & Comparative Law
No abstract provided.
Understanding Medical Records In The Twenty-First Century,
2017
Barry University School of Law
Understanding Medical Records In The Twenty-First Century, Samuel D. Hodge, Jr., Joanne Callahan
Barry Law Review
No abstract provided.
Implementing The International Health Regulations (2005) With Search Engine-Based Syndromic Surveillance,
2017
University of Georgia School of Law
Implementing The International Health Regulations (2005) With Search Engine-Based Syndromic Surveillance, Ryan Sullivan
Georgia Journal of International & Comparative Law
No abstract provided.
Covering The Care: Cost Sharing Reductions In Nh,
2017
University of New Hampshire Institute for Health Policy and Practice
Covering The Care: Cost Sharing Reductions In Nh, Jo Porter, Lucy C. Hodder
Law Faculty Scholarship
This brief uses national data to describe the NH population who received Cost Sharing Reductions for coverage on the NH Marketplace.
Covering The Care: A Focus On The Nh Marketplace,
2017
University of New Hampshire Institute for Health Policy and Practice
Covering The Care: A Focus On The Nh Marketplace, Jo Porter, Lucy C. Hodder
Law Faculty Scholarship
The second brief uses national and state data to describe the NH population enrolled in the health insurance plans through the NH Marketplace.
Covering The Care: Health Insurance Coverage In New Hampshire,
2017
University of New Hampshire Institute for Health Policy and Practice
Covering The Care: Health Insurance Coverage In New Hampshire, Jo Porter, Lucy Hodder
Law Faculty Scholarship
the first in a series of data and policy briefs that seek to inform the current conversations about health reform happening across the state. The first brief uses data from the American Community Survey to provide information about the health insurance coverage landscape in NH.
Beyond The Money: Expected (And Unexpected) Consequences Of America's War On Drugs,
2017
Lincoln Memorial University
Beyond The Money: Expected (And Unexpected) Consequences Of America's War On Drugs, Cynthia Brown
Lincoln Memorial University Law Review Archive
The purpose of this paper is to provide a high-level survey of our nation’s prohibition policies within the context of the costs of the law enforcement efforts upholding those policies. The discussion will offer a cursory review of the economic expense of the war on drugs with tangential coverage of the constitutional, institutional and intangible expenses that are inseparable from an assessment of the costs of America’s drug control efforts. Part I provides a historical review of illicit drug use in the United States, while Part II supplies the evolution of the country’s efforts to codify its drug control policies. …
