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Articles 1 - 22 of 22
Full-Text Articles in Law
Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim
Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim
Faculty Publications By Year
There is, without question, a public health crisis in the United States arising from both illicit and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration (FDA) is one regulator with an important role to play in minimizing the harms associated with prescription opioids, while also ensuring that prescription opioids are available for the evidence-based management of pain. One question, however, is to what extent the agency can consider in its decisions to approve opioids and keep existing ones on the market the provider and patient behaviors contributing to the epidemic. This is, in part, because FDA’s approval …
Pharmaceutical Federalism, Patricia J. Zettler
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 …
The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler
The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler
Faculty Publications By Year
The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as …
The Comprehensive Capital Analysis And Review And The New Contingency Of Bank Dividends, Robert Weber
The Comprehensive Capital Analysis And Review And The New Contingency Of Bank Dividends, Robert Weber
Faculty Publications By Year
No abstract provided.
Crafting Comment Letters: Teach Policy, Develop Skills, And Shape Pending Regulation, Nicole G. Iannarone, Benjamin P. Edwards
Crafting Comment Letters: Teach Policy, Develop Skills, And Shape Pending Regulation, Nicole G. Iannarone, Benjamin P. Edwards
Faculty Publications By Year
This essay unpacks the regulatory comment letter process and how to incorporate it into the law school curriculum. Participating in live rulemaking offers unique opportunities for students, from mastering the substantive area of law, developing critical thinking skills, and developing their professional identities and expertise. We describe our own experiences in incorporating students into the regulatory rulemaking process. Because of our focus on securities law, our students review and comment on proposed actions by securities regulators — the Financial Industry Regulatory Authority (FINRA) and Securities and Exchange Commission (SEC). After providing an overview of the pedagogical and practical rationale for …
Resurrecting Health Care Rate Regulation, Erin C. Fuse Brown
Resurrecting Health Care Rate Regulation, Erin C. Fuse Brown
Faculty Publications By Year
Our excess health care spending in the United States is driven largely by our high health care prices. Our prices are so high because they are undisciplined by market forces, in a health care system rife with market failures, which include information asymmetries, noncompetitive levels of provider market concentration, moral hazard created by health insurance, multiple principal-agent relationships with misaligned incentives, and externalities from unwarranted price variation and discrimination. These health care market failures invite a regulatory solution. An array of legal and policy solutions are typically advanced to control our health care prices and spending, including: (1) market solutions …
Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler
Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler
Faculty Publications By Year
No abstract provided.
Compassionate Use Of Experimental Therapies: Who Should Decide?, Patricia J. Zettler
Compassionate Use Of Experimental Therapies: Who Should Decide?, Patricia J. Zettler
Faculty Publications By Year
In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy-based Stamina Foundation's unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients' requests for early access to experimental medicines with requirements for demonstrating safety and effectiveness. Compassionate use of the Stamina therapy arguably should not have been permitted under Italy's laws, but public pressure was intense and judges ultimately granted access. One lesson from these events is that expert regulatory agencies may be the institutions most competent to make compassionate use decisions and that policies should include …
Regulatory Competitive Shelters In The Area Of Personalized Medicine, Yaniv Heled
Regulatory Competitive Shelters In The Area Of Personalized Medicine, Yaniv Heled
Faculty Publications By Year
No abstract provided.
Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler
Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler
Faculty Publications By Year
The conventional wisdom in U.S. health law and policy holds that states regulate medical practice – the activities of physicians and other health care professionals – while the federal government regulates medical products. But relying on states as the principal regulators of medical practice has, at times, driven law and policy in directions that are problematic from a public health perspective, as demonstrated by a deadly 2012 outbreak of fungal meningitis that was linked to a state-regulated practice known as drug compounding. This Article argues that the federalism concerns underlying the conventional wisdom are misplaced. It demonstrates that, contrary to …
Weathering Nepa Review: Superstorms And Super Slow Urban Recovery, John Travis Marshall
Weathering Nepa Review: Superstorms And Super Slow Urban Recovery, John Travis Marshall
Faculty Publications By Year
Delays in implementing long-term neighborhood housing recovery measures following urban disasters profoundly disrupt a city's revitalization and resurgence. Following recent large-scale urban disasters, some blame the National Environmental Policy Act environmental and historical review requirement for greatly slowing the long-term recovery process. They claim that the National Environmental Policy Act review is ill suited for the exigencies of disasters. Finding effective ways to advance urban disaster recovery as quickly as possible, while not compromising key environmental quality objectives, is a central challenge to implementing effective post-disaster recovery plans. This Article addresses how best to balance necessary regulation with critical disaster …
Regulating The Science Of Forensic Evidence: A Broken System Requires A New Federal Agency, Jessica D. Gabel, Ashley D. Champion
Regulating The Science Of Forensic Evidence: A Broken System Requires A New Federal Agency, Jessica D. Gabel, Ashley D. Champion
Faculty Publications By Year
Professor Gabel and Ms. Champion agree with Mr. Goldstein's argument that serious validity and reliability problems plague forensic science, but, using the recent Troy Davis case in Georgia as an illustration, they argue for federal rather than state oversight. Gabel and Champion assert that many states lack the funding to construct an adequate system and that the fragmentation caused by different state systems would be a significant impediment to reform. They suggest a federal agency that, like the Environmental Protection Agency, would set minimum standards but allow states to experiment with enhanced regulation.
Rainwater Recapture: Development Regulations Promoting Water Conservation, Julian C. Juergensmeyer
Rainwater Recapture: Development Regulations Promoting Water Conservation, Julian C. Juergensmeyer
Faculty Publications By Year
The increasing need for water conservation in the eastern as well as western parts of the United States is focusing attention on rainwater recapture. The technology available is effective and relatively inexpensive. Using land development regulations to require or encourage new development to incorporate rainwater recapture facilities is one approach to alleviation of local water shortages.
From A Constitutional Right To A Policy Of Exceptions: Abigail Alliance And The Future Of Access To Experimental Therapy, Patricia J. Zettler, Seema K. Shah
From A Constitutional Right To A Policy Of Exceptions: Abigail Alliance And The Future Of Access To Experimental Therapy, Patricia J. Zettler, Seema K. Shah
Faculty Publications By Year
Although there has been considerable attention to the plight of terminally ill patients with highly sympathetic constitutional and contractual claims that they should be permitted access to unapproved drugs, courts have been appropriately reluctant to grant such claims. Congress and administrative agencies have the requisite institutional competence to decide complex policy issues related to science and health care such as those involved in establishing an expanded access program. Congress and FDA should allow only limited access to unapproved therapies because there are significant concerns about the safety and efficacy of unapproved drugs. Moreover, many of the proposals to widen access …
The Implications Of Post-Phase 1 And "Off-Label" Treatment Use Of Experimental Drugs: How Expansive Should Expanded Access Be?, Patricia J. Zettler
The Implications Of Post-Phase 1 And "Off-Label" Treatment Use Of Experimental Drugs: How Expansive Should Expanded Access Be?, Patricia J. Zettler
Faculty Publications By Year
No abstract provided.
Agency Activism As A New Way Of Life: Administrative Modification Of The Internal Revenue Code Through Limited Issue Focused Examinations, W Edward Afield
Agency Activism As A New Way Of Life: Administrative Modification Of The Internal Revenue Code Through Limited Issue Focused Examinations, W Edward Afield
Faculty Publications By Year
In the name of increasing efficiency and better utilizing limited resources, the IRS has begun to adopt audit policies that overly favor taxpayers and greatly hinder the IRS’s ability to perform thorough audits. Highlighting this trend is a relatively new audit technique used by the Large to Mid-Size Business Division (LMSB), known as the Limited Issue Focused Examination (LIFE) Process. Under LIFE, the LMSB has attempted to involve taxpayers in the audit process by sharing responsibility for timely completion of the audit and has attempted to streamline the audit by reducing the scope of issues examined and applying materiality thresholds …
Billboards And Big Utilities: Borrowing Land-Use Concepts To Regulate "Nonconforming" Sources Under The Clean Air Act, Deepa Varadarajan
Billboards And Big Utilities: Borrowing Land-Use Concepts To Regulate "Nonconforming" Sources Under The Clean Air Act, Deepa Varadarajan
Faculty Publications By Year
No abstract provided.
Birth Registration: An Essential First Step Toward Ensuring The Rights Of All Children, Jonathan Todres
Birth Registration: An Essential First Step Toward Ensuring The Rights Of All Children, Jonathan Todres
Faculty Publications By Year
Birth registration, the official recording of a child's birth by a government agency, is one of the most important events in a child's life. Birth registration establishes the existence of the child under law and provides the foundation for ensuring many of the child's rights. Although birth registration alone does not guarantee that a child will have access to adequate health care, receive an education, or be free from abuse or exploitation, its absence leaves a child at greater risk of a range of human rights violations. Despite the importance of birth registration, according to UNICEF, approximately 50 million newborn …
Forms Of Federal Statutory Publication, Elizabeth G. Adelman, Kristina L. Niedringhaus
Forms Of Federal Statutory Publication, Elizabeth G. Adelman, Kristina L. Niedringhaus
Faculty Publications By Year
No abstract provided.
A Regulatory Model For Genetic Testing In Employment, Jack F. Williams
A Regulatory Model For Genetic Testing In Employment, Jack F. Williams
Faculty Publications By Year
No abstract provided.
The Future Of Government Regulation Of Agriculture: An Introduction, Julian C. Juergensmeyer
The Future Of Government Regulation Of Agriculture: An Introduction, Julian C. Juergensmeyer
Faculty Publications By Year
No abstract provided.
Prospects For Structural Reform Of The Bankruptcy System, Marjorie L. Girth
Prospects For Structural Reform Of The Bankruptcy System, Marjorie L. Girth
Faculty Publications By Year
No abstract provided.