A Decade’s Quest for Safer Drugs: Congressional Committee Green Lights Regulation of Drug Supply Chains and Compounding Manufacturers

On May 22. 2013, the Senate Health, Education, Labor and Pensions (HELP) Committee unanimously approved S.959, “The Pharmaceutical Compounding Quality and Accountability Act,” and S.957, “The Drug Supply and Security Act,” (now incorporated into S. 959 as an amendment). Congressional efforts to enact comprehensive legislation to improve drug safety and secure the nation’s drug supply chain have lingered for over a decade. The lack of federal uniformity has allowed a patchwork of state legislation to emerge, attracting the less scrupulous to those states with the lowest security. The issue finally gained traction among HELP Committee members when 55 people died and 741 more became ill after contracting fungal meningitis from contaminated steroid injections made by the New England Compounding Center (NECC). Committee member Sen. Pat Roberts (R-KS) stated that given prior reports of problems with NECC, this tragedy could have been averted but for a “shocking failure to act” by NECC, state and federal regulators, and Congress

Medical Malpractice, the Affordable Care Act and State Provider Shield Laws: More Myth than Necessity?

Given the ambitions and reach of the Affordable Care Act, confusion about its intended and inadvertent impact is inevitable. Since its enactment in 2010, the ACA has raised legitimate and less grounded concerns among various stakeholders ranging from individuals and employers facing coverage mandates to States deciding whether and how to implement the Act’s Medicaid expansions. One item has received far less attention even though it weighs heavily on any provider engaged in the clinical practice of medicine: the ACA’s impact on medical malpractice liability. The Act does little to address medical malpractice head on. Nevertheless, physicians and other providers, the states and even some members of Congress have expressed concern that the Act will increase a provider’s exposure to medical malpractice liability

The ACA’s Tobacco Use Rating: Implementation, Inconsistencies and Ironies

As the Affordable Care Act continues toward full implementation, the law’s complexity is on full display. As we have noted in earlier writings, the ACA continues the federal tradition of using a fragmented approach to allocating oversight responsibilities among federal and state regulators, while maintaining the role of private actors in health care insurance and delivery systems. The result is a dizzying array of plan types (self-insured, fully insured, small market, individual market, large market, grandfathered) subject to an equally dizzying blend of ACA, ERISA, and individual state requirements

Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies

Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanaka’s receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly. Gurdon and Yamanaka demonstrated that pluripotent cells may also be formed by reprogramming adult cells to an embryonic state, resulting in induced pluripotent stem (iPS) cells without having to use eggs or cloning, or destroy embryos. However derived, pluripotent cells are capable of differentiating into virtually any cell type in the human body. This imbues them with great promise for scientific breakthroughs and medical advances, but also raises serious ethical, legal and safety concerns about their use

Individual And Group Coverage Under The ACA: More Patches To The Federal-State Crazy Quilt

From the introduction: Throughout the 2012 Presidential campaign, Republican contenders criticized the Affordable Care Act (ACA) as a “federal take-over of health care” for its promotion of national uniformity in health coverage and access. Yet long before passage, the architects of the ACA quickly rejected a federal single payor system, or even a federal public plan to complement the private sector plans due to forceful opposition to national reform. Instead, they traveled the only politically viable road to reform: maintaining the fragmented and complex system of health care coverage, where federal and state governments as well as the private sector play pivotal roles. The ACA’s expansion of coverage is accomplished by continuing and even increasing state oversight, reinforcing the private market, and involving both employers and individuals. As enacted, therefore, the ACA’s fragmented approach to health reform is clearly not a federal take-over

The Supreme Court Upholds The Individual Mandate: But Who Are We Talking About?

From the introduction: While the Affordable Care Act’s individual mandate survived constitutional scrutiny in NFIB v. Sebelius, a Republican president and/or changes in the House or Senate this fall could lead to its demise. As campaigns shift into high gear, the law’s opponents will undoubtedly draw on the strident and jointly authored dissent of Justices Scalia, Kennedy, Thomas, and Alito. Despite the value of robust debate, relying on the dissent may be problematic due to its misperceptions about the ACA and the realities of health care. Thus, while we considered what we were waiting for in the weeks before the decision, the Court’s ruling raises a new question: “Who Are We Talking About?

Alice Noble And Mary Ann Chirba On Severability: Life Is A Highway

Substantive analysis of the role of severability of issues in the U.S. Supreme Court\u27s handling of the multiple and complex issues in the Obamacare case

The Supreme Court On The Affordable Care Act: What We Are Waiting For

From the introduction: With the U.S. Supreme Court poised to rule on the Affordable Care Act (ACA) it is worth reminding ourselves of what, exactly, we have been waiting for. We await a judicial opinion that could deliver a decisive blow to all or part of a massive piece of legislation and the hard-fought battles that led to its enactment, or salvage the near-century-old quest for health care reform. At the same time we await an opinion that may reshape our fundamental understanding of the Court, the power of Congress, and long-standing principles of federalism

National Federation of Independent Business v. Sebelius, 567 U.S. 519 (2012)

In National Federation of Independent Business v. Sebelius, decided in 2012, twenty-six states as well as private individuals and an organization of independent businesses challenged the constitutionality of two key components of the Affordable Care Act. The Court upheld the individual mandate but converted the Medicaid eligibility expansion from mandatory to optional for states. Elizabeth Weeks’ feminist rewrite breaks down the public law-private law distinction to get beyond the traditional view of health insurance as a commercial product providing individual financial protection against risk and instead to view it as effecting a risk pool premised on cross-subsidization of the health-care “haves” by the health-care “have-nots.” Weeks also rejects the original opinion’s dichotomy between “old” and “new” Medicaid as an artifice evidencing a fundamental discomfort with extending public assistance to able-bodied people who are judged capable of providing for themselves on the private market. In their commentary, Mary Ann Chirba and Alice Noble assess the original opinion and Weeks’ feminist rewrite in terms of their concrete effects on women’s lives