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Full-Text Articles in Law

Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim Jan 2018

Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim

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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 ...


Pharmaceutical Federalism, Patricia J. Zettler Jul 2017

Pharmaceutical Federalism, Patricia J. Zettler

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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 ...


The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler Jan 2017

The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler

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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 ...


Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler Nov 2015

Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler

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No abstract provided.


Compassionate Use Of Experimental Therapies: Who Should Decide?, Patricia J. Zettler Jul 2015

Compassionate Use Of Experimental Therapies: Who Should Decide?, Patricia J. Zettler

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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 ...


Regulatory Competitive Shelters In The Area Of Personalized Medicine, Yaniv Heled Jul 2015

Regulatory Competitive Shelters In The Area Of Personalized Medicine, Yaniv Heled

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No abstract provided.


Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler Jan 2015

Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler

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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 the ...


Patents Vs. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both?, Yaniv Heled Jan 2012

Patents Vs. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both?, Yaniv Heled

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On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (also known as the Healthcare Bill). BPCIA sets up a framework for the approval of generic biologics and provides for up to 12.5 years of market exclusivity for FDA approved bio-pharmaceutical products. The exclusivity is intended to run in parallel and in addition to any patents that may apply to such approved bio-pharmaceutical products, which would also grant the developers of these products monopolies in the underlying technologies on which such bio-pharmaceutical ...


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 Jan 2010

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

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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 Jan 2009

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.


Expedited Partner Therapies For Sexually Transmitted Diseases: Legal And Policy Approaches, James G. Hodge, Erin C. Fuse Brown Jan 2008

Expedited Partner Therapies For Sexually Transmitted Diseases: Legal And Policy Approaches, James G. Hodge, Erin C. Fuse Brown

Faculty Publications By Year

No abstract provided.