|Present||Associate Professor of Law, Georgia State University College of Law ‐ Center for Law, Health and Society|
|J.D., with distinction, Stanford University|
|B.A., with distinction and departmental honors, Stanford University|
phone: (404) 413-9094
Contributions to Books (1)
Implementing a Public Health Perspective in FDA Drug Regulation Food and Drug Law Journal (2018)
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 ...
Pharmaceutical Federalism 92 Indiana Law Journal 845 (2017) (2017)
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 ...
The Challenge of Paying for Cost-Effective Cures American Journal of Managed Care (2017)
In this article, we consider the problem of financing highly effective and cost-effective prescription drugs within a value-based pricing system. Precisely because these drugs are highly effective, their value-based prices may be quite expensive; and ...
The Indirect Consequences of Expanded Off-Label Promotion Ohio State Law Journal (2017)
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 ...
Compassionate Use of Experimental Therapies: Who Should Decide? EMBO Molecular Medicine (2015)
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' ...
Toward Coherent Federal Oversight of Medicine San Diego Law Review (2015)
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 ...
The Strange Allure of State "Right-to-Try" Laws JAMA Internal Medicine (2014)
State right-to-try laws revive a decades-long debate about balancing early access to unapproved medications for terminally ill patients with requirements for demonstrated safety and effectiveness. Although the legal approach is novel, there are many reasons ...
23andMe, the Food and Drug Administration, and the Future of Genetic Testing JAMA Internal Medicine (2014)
On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing ...
From a Constitutional Right to a Policy of Exceptions: Abigail Alliance and the Future of Access to Experimental Therapy Yale Journal of Health Policy, Law, and Ethics (2010)
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 ...
Is It Cheating to Use Cheetahs?: The Implications of Technologically Innovative Prostheses for Sports Values and Rules Boston University International Law Journal (2009)
This Article uses the case of Oscar Pistorius – the South African runner and amputee who competed with blade-like, lower-leg prostheses – to analyze how the International Association of Athletic Federations (IAAF), the world governing ...
A New Era in the Ethics of Human Embryonic Stem Cell Research Stem Cells (2005)
Scientific progress in human embryonic stem cell (hESC) research and increased funding make it imperative to look ahead to the ethical issues generated by the expected use of hESCs for transplantation. Several issues should be ...