On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Eschenbach, held that terminally ill patients who have exhausted all other available options have a constitutional right to experimental treatment that FDA has not yet approved. Although ultimately overturned by the full court, Abigail Alliance generated considerable interest from various constituencies. Meanwhile, FDA proposed similar regulatory amendments, as have lawmakers on both sides of the aisle in Congress. But proponents of expanded access fail to consider public health and consumer safety concerns. In particular, allowing patients to try unproven treatments, outside of controlled clinical trials risks both the study's outcome and the health of patients who might benefit from the deliberate, careful process of new drug approval as it currently operates under FDA's auspices.

No abstract

and law degree from the University of Georgia. She has published numerous articles and book chapters on public health law, health care financing, health care reform, and health care federalism.

The Patient Protection and Affordable Care Act (ACA) represents the most significant reform of the United States health care system in decades. ACA also substantially amplifies the federal role in health care regulation. Among other provisions, ACA expands government health care programs, imposes detailed federal standards for commercial health insurance policies, creates national requirements on employers and individuals, and enlists state administrative capacity to implement various federal reforms. In response, a persistent voice in the protracted, contentious debate surrounding ACA was, and continues to be, resistance from states. The rhetoric of federalism — states’ rights, reserved powers, state sovereignty, limited government, and local diversity — resonates deeply even around provisions of ACA that do not specifically implicate state interests. For example, the loudest and most persistent state objections target the new mandate that individuals maintain health insurance, a requirement imposed by ACA and enforced through federal tax penalties.

No abstract