Do terminally ill patients who have exhausted all other available, government-approved treatment options have a constitutional right to experimental treatment that may prolong their lives? 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. Von Eschenbach, held “Yes.” The plaintiffs, Abigail Alliance for Better Access to Developmental Drugs and Washington Legal Foundation, sought to enjoin the Food and Drug (...) Administration from refusing to allow the sale of investigational new drugs that had not yet received FDA approval. The terminally ill plaintiffs contended that they quite literally could not wait that long for the drugs. With no other treatment options available, the plaintiffs urged the court to recognize a fundamental, constitutional right to take potentially life-saving or life-prolonging drugs, even though the treatment had not been fully tested through human trials for safety and effectiveness and could not be legally marketed to the public. (shrink)

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. (shrink)

The Patient Protection and Affordable Care Act 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. (shrink)

The Patient Protection and Affordable Care Act 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. (shrink)

In long Midwestern winters, two things are certain: snow and basketball. But two things that you cannot count on are snow day school closures and a home-team collegiate basketball championship. In Kansas last winter, we had both. Winter precipitation was much above average, resulting in a rare invocation of the University's inclement weather policy to cancel classes in early February. And the Kansas Jayhawks basketball team brought home the National Collegiate Athletic Association championship trophy for the first time in two (...) decades. The Chancellor commemorated the achievement with a campuswide celebration, including all-day class cancellation. This is all well and good. I am all for respecting Mother Nature's forces and celebrating remarkable athletic accomplishments.But the combination of events does leave law professors nearing the end of the semester in a bit of a quandary. How to make up the cancelled classes to ensure compliance with American Bar Association accreditation instructional hours requirements? How to cover the missed course content? How to find mutually agreeable make-up class times and locations with a group of busy, upper-level law students? (shrink)

In long Midwestern winters, two things are certain: snow and basketball. But two things that you cannot count on are snow day school closures and a home-team collegiate basketball championship. In Kansas last winter, we had both. Winter precipitation was much above average, resulting in a rare invocation of the University's inclement weather policy to cancel classes in early February. And the Kansas Jayhawks basketball team brought home the National Collegiate Athletic Association championship trophy for the first time in two (...) decades. The Chancellor commemorated the achievement with a campuswide celebration, including all-day class cancellation. This is all well and good. I am all for respecting Mother Nature's forces and celebrating remarkable athletic accomplishments.But the combination of events does leave law professors nearing the end of the semester in a bit of a quandary. How to make up the cancelled classes to ensure compliance with American Bar Association accreditation instructional hours requirements? How to cover the missed course content? How to find mutually agreeable make-up class times and locations with a group of busy, upper-level law students? (shrink)