As this Article is being written, the Patient Protection and Affordable Care Act (ACA) is being besieged with two different types of challenges. The first is a Commerce Clause challenge to the individual mandate on the ground that, although the Commerce Clause allows the government to “regulate” the transactions into which people choose to enter, it does not allow the state to force people to enter into disadvantageous transactions against their own will. The second of these challenges deals with the imposition of the Medicaid expansion provisions requiring a state to forego all of its additional Medicaid support unless it is prepared to extend Medicaid coverage, partially at its own expense, to individuals whose income levels put them at 100% to 133% of the federal poverty level.

In 2007, Congress granted the Food and Drug Administration (FDA) new powers to order pharmaceutical companies to conduct drug safety studies and clinical trials in the postmarketing period after drugs are approved. The methodologies include observational studies that examine patients' insurance claims data and clinical records to infer whether drugs are safe in actual clinical practice. Such studies offer a valuable tool for improving drug safety, but they raise ethical and privacy concerns because they would entail widespread use of patients' health information in commercial research by drug manufacturers. This is the first article to explore the ethics of these section 505(o)(3) observational studies, so named after the section of the Food, Drug, and Cosmetic Act that authorizes them.

Data access problems threaten to make the FDA's section 505(o)(3) study requirements unenforceable. Under existing federal privacy regulations, it appears highly unlikely that pharmaceutical companies will have reliable access to crucial data resources, such as insurance claims data and healthcare records, to use in these studies. State privacy laws present another potential barrier to data access. If pharmaceutical companies do manage to gain access to the needed data, this will raise serious privacy concerns because section 505(o)(3) observational studies do not appear to be covered by any of the major federal regulations that afford ethical and privacy protections to persons whose data are used in research.

If the FDA's program of section 505(o)(3) observational studies fails because of the above problems, this failure will have a number of bad consequences: the public will be exposed to avoidable drug safety risks; taxpayers may be forced to bear the costs of having the FDA conduct drug safety investigations that would have been funded by drug manufacturers if data had been available; and, perhaps most troubling, the FDA may be forced to order postmarketing clinical trials to answer questions that could have been answered using observational studies. Problems with access to data for section 505(o)(3) studies thus could directly imperil human research subjects by forcing a needless over-reliance on risky postmarketing drug safety trials.

This Article concludes by describing a promising new legal pathway for resolving these problems. Congress has provided the FDA a new set of powers that if skillfully exercised will allow the agency: (1) to facilitate pharmaceutical companies' appropriate access to data for use in section 505(o)(3) observational studies, (2) to impose strict ethical and privacy protections for persons whose data are used in these studies, and (3) to mobilize private-sector funding to generate much-needed evidence of the safety of FDA-approved drugs.

National advisory committees have considered the obligations owed to research participants in the event of research-related injuries. These committees have repeatedly concluded that injured research participants are entitled to compensation for their injuries, that the tort system provides inadequate remedies, and that the United States should adopt no-fault compensation. But because the advisory committees have made no concrete proposals and have taken no steps toward implementing no-fault compensation, the United States continues to rely on the tort system to compensate injured research participants.

This Article argues that recent legal developments and a transformation in the global research landscape make maintaining the status quo morally indefensible and practically unsustainable. Recent legal developments exacerbate the longstanding difficulties associated with the tort system as a method of compensation; nearly every injured research participant will have difficulty recovering damages, and certain classes of injured research participants—those in federal research and those abroad—are prevented from recovering altogether, resulting in substantial unfairness. In the past ten years, many of the countries substantially involved in research have mandated systematic compensation. By not mandating compensation, the United States has become a moral outlier and risks having its noncompliant research embargoed by foreign ethics committees, thereby delaying important biomedical advances.

This Article examines alternative compensation mechanisms and offers a concrete no-fault compensation proposal built on systems already in place. The proposed system can be implemented in the United States and countries around the world to help harmonize various national compensation systems and to more equitably and effectively make those injured by research whole.

Reducing the incidence of HIV infection continues to be a crucial public health priority in the United States, especially among populations at elevated risk such as men who have sex with men, transgender women, people who inject drugs, and racial and ethnic minority communities. Although most HIV prevention efforts to date have focused on changing risky behaviors, the past decade yielded efficacious new biomedical technologies designed to prevent infection, such as the prophylactic use of antiretroviral drugs and the first indications of an efficacious vaccine. Access to prevention technologies will be a significant part of the next decade's response to HIV, and advocates are mobilizing to achieve more widespread use of these interventions. These breakthroughs, however, arrive at a time of escalating healthcare costs; health insurance coverage therefore raises pressing new questions about priority-setting and the allocation of responsibility for public health. The goals of this Article are to identify legal challenges and potential solutions for expanding access to biomedical HIV prevention through health insurance coverage. This Article discusses the public policy implications of HIV prevention coverage decisions, assesses possible legal grounds on which insurers may initially deny coverage for these technologies, and evaluates the extent to which these denials may survive external and judicial review. Because several of these legal grounds may be persuasive, particularly denials on the basis of medical necessity, this Article also explores alternative strategies for financing biomedical HIV prevention efforts.

On August 22, 2009, when then-Speaker of the House Nancy Pelosi was asked by a reporter whether the Patient Protection and Affordable Care Act (PPACA) was constitutional, she answered: “Are you serious? Are you serious?” Two years later, many federal judges, more than half of the States, and a flood of distinguished constitutional scholars have examined the PPACA and found at least part of it to be unconstitutional. The question was indeed serious.

It remains serious today, as a Supreme Court decision on the constitutionality of the PPACA is expected in June 2012. Because the legality of the PPACA has emerged as perhaps the most publicly visible constitutional question since Roe v. Wade, clarity is vital not only for the PPACA itself, but also for general public understanding of the Constitution. Accordingly, our goals in this Article are to provide an opinionated but hopefully fair-minded guide to the constitutional issues of the PPACA and to clarify some misunderstandings that plague both popular and professional discussions of the issues.

Access to medicine remains a core challenge of global health, despite progress in bringing affordable HIV/AIDS drugs to developing countries. Yet, the debate seems to have shifted. For a long time it focused on two specific issues: (1) whether and to what extent international trade agreements that strengthen patent protection hindered states and NGOs in their efforts to promote access to life-saving medicines at reasonable costs; and (2) whether access to life-saving therapies could be seen as a component of the right to health. The challenge for access to medicines appears at this point, however, to be more political than legal. Indeed, from a legal perspective, it seems fairly settled that international trade agreements permit, under certain conditions, the production and sale or export of generic versions of pharmaceutical products that address an important public health threat in developing countries. The concept of the right to health has often been invoked in this international context. An increasing number of domestic court decisions also explicitly acknowledge that access to life-saving therapies can be seen as a component of the right to health.

This Article analogizes early semiconductor technology and its surrounding economics with isolated genes, stem cells, and related bioproducts, and their surrounding economics, to make the case for sui generis (of its own class) intellectual property protection for isolated bioproducts. Just as early semiconductors failed to meet the patent social bargain requiring novelty and non-obviousness in the 1980s, isolated genes and stem cells currently fail to meet the patent bargain requirements of non-obviousness and eligible subject matter that entitle them to traditional intellectual property protection. Like early semiconductor chip designs, nevertheless, the high cost of upstream bioproduct research and development, coupled with the need to sustain continued economic growth of the biotechnology industry, mandates that Congress provide some level of exclusive rights to ensure continued funding for this research. Sui generis intellectual property protection for isolated bioproducts would preserve the incentive to continue innovation in the field. As illustrated by the semiconductor industry, however, such sui generis protection for this technology must include limitations that address the need to provide an appropriate level of public access to facilitate downstream product development and enrich the public domain.

The lawsuits challenging Obamacare’s individual mandate have exposed a rift in federalism theory. On one side of the divide is a view that the national government ought to intervene—and ought to be constitutionally permitted to intervene—whenever the states are “separately incompetent” to regulate a particular subject. According to this view, the primary purpose of the Constitution’s enumeration of national powers is to authorize Congress to fix collective action problems among the states. Borrowing from Robert Cooter and Neil Siegel’s article of the same name, I refer to this view as “collective action federalism.” On the other side of the divide is a view that federalism exists for reasons other than efficiency of regulation and particularly that the Founders created the federal structure for the protection of individual liberty. According to this view, there is inherent value to state power that ought to be preserved against national encroachments.

Generic drugs represent a significant portion of the medical arsenal in treating disease. As copies of originator drugs, these drugs have been permitted abbreviated approval under the Hatch-Waxman Act. Yet with the current cost focus upon generic formulations, potential safety issues with generics have arisen. Although there is an established criterion of “bioequivalence” that generic formulations must demonstrate, narrow-therapeutic index drugs for sensitive clinical circumstances such as epilepsy, antiplatelet therapies, and mental health treatments may require different regulatory treatment than other generic drugs. Further, in these circumstances, differences in generic formulations may lead to adverse clinical outcomes due to less stringent bioequivalence tolerances. Yet there is no mandate for comparison between different generic formulations. Countries outside the United States advocate for narrowing tolerance ranges for these high risk health situations and the drugs for their treatment. We argue in this paper that additional patient safety matters must be taken into account for narrow therapeutic disease drugs, and regulatory bodies should emphasize greater tightness in bioequivalence before these narrow-therapeutic drug generic formulations are approved.

Healthcare deficiencies in the United States have long been perpetuated by a shortage of primary care providers. A core purpose of the Patient Protection and Affordable Care Act (PPACA) is to provide health insurance for America's approximately fifty million uninsured. Implementation of universal health insurance, however, does not mean sufficient healthcare access for all, since the supply of physicians does not and will not meet demand. For reasons reviewed in this Article, the current physician shortage mainly impacts primary care providers. This shortage is particularly troubling because increased provision of primary care relative to specialty care has been associated with improvement in health outcomes, disease prevention, cost effectiveness, and coordination of care. This Article highlights provisions in the PPACA that impact primary care physicians. Finally, this Article proposes the creation of a universal primary care loan repayment program and a national residency exchange designed to alleviate the U.S. primary care crisis by facilitating optimal distribution of resident physicians in each medical specialty based on community need.

In Sorrell v. IMS Health Inc., the Supreme Court departed from traditional commercial speech doctrine in striking down Vermont's Prescription Confidentiality Law under a heightened level of scrutiny. The Prescription Confidentiality Law was Vermont's attempt to prevent pharmacies from sharing information about doctors’ prescribing habits with drug manufacturers without the consent of the doctor. The law aimed to protect doctors, as well as to promote public health, by regulating speech and conduct that is arguably commercial in nature. The Court has purported to subject regulation of commercial speech to only an intermediate level of scrutiny since Virginia State Board of Pharmacy v. Virginia Citizen's Consumer Council, Inc. established that as the proper standard. Thus, it was inconsistent for the Court to categorize the commercial speech regulation in Sorrell as “content-based” and thus subject to a stricter level of review. The invalidation of the Prescription Confidentiality Law, however, is only the most recent development in the Court's strict treatment of health-related regulations infringing on commercial speech. The Court has been moving toward a more stringent level of scrutiny since first applying the commercial speech doctrine in a public health context in Rubin v. Coors.

Although international covenants have long recognized a fundamental right to healthcare, and other countries provide healthcare coverage for all of their citizens, rights to healthcare in the United States have been adopted only grudgingly, and in a manner that is inherently unstable. While a solid right to healthcare would provide much benefit to individuals and society, the political and judicial branches of the U.S. government have granted rights that are incomplete and vulnerable to erosion over time.

Unfortunately, enactment of the Patient Protection and Affordable Care Act (ACA) does not change these fundamental weaknesses in the regime of U.S. healthcare rights. Millions of Americans will remain uninsured after ACA takes full effect, and rather than creating a more stable right to healthcare, ACA gives unstable rights to more people. As a result, even if ACA survives its constitutional challenges, access to healthcare still will be threatened by the potential for attrition of the rights that ACA provides.

Imagine an American physician working with Pathfinder International's Mukta Project to combat the prevalence and spread of Sexually Transmitted Infections (STIs) and HIV in Maharashtra, India. The physician provides HIV/AIDS prevention and treatment services at a health clinic as well as coordinates educational programs about STIs for local residents. A young woman approaches the physician's clinic. The woman tentatively informs the physician that she has recently entered the local sex trade and may have contracted HIV. The physician wishes she could speak freely about the realities of prostitution in India. The physician wishes she could empower her new patient to adopt behaviors that would reduce her vulnerability to HIV/AIDS. In spite of any professional or personal opinions the physician might hold on the subject of prostitution, however, she must choose her words carefully. In order to receive program funding from the United States government, Pathfinder International has reluctantly endorsed a strict anti-prostitution policy, and the physician is prohibited from engaging in any activities that are inconsistent with that policy.

More than twenty-four million people in the United States are considered limited English proficient (LEP), and numerous studies have documented the consequences of communication barriers in healthcare. These consequences include: patients’ inability to become engaged and involved in their care; the absence of crucial information—including cultural information—essential to healthcare quality; risks to patient safety arising from the misunderstanding of physician instructions; and ethical and legal lapses stemming from the absence of informed consent. Addressing healthcare rights necessarily entails coming to grips with how to facilitate communication and the exchange of information between the healthcare system and an increasingly diverse patient population.

The history of language access services in healthcare is grounded in two distinct bodies of law: the law of informed consent and civil rights law. Modern notions of informed consent law—which have their roots in the Nuremberg trials of the late 1940s—would recognize a cause of action in tort where a lack of adequate communication creates a barrier to an LEP patient's ability to consent to care. In modern healthcare law, the ability of patients to affirmatively give informed consent to treatment is considered a fundamental element of healthcare quality.

Proponents of the 2010 Patient Protection and Affordable Care Act (PPACA) justify the Act's mandate that uninsured individuals either purchase a minimally defined health insurance policy (“Maintain Minimum Essential Coverage”) or pay a fine, as a necessary and proper exercise of Congress's express constitutional power to regulate interstate and foreign commerce. The United States Supreme Court will decide the correctness of that highly debatable position during its spring 2012 session.

Assuming, without by any means predicting, that the validity of all parts of the PPACA—including the individual insurance mandate—is upheld, the Court's (likely multiple) opinions will constitute a major development in the evolution of American constitutional jurisprudence, even if Congress subsequently repeals specific sections of the legislation. Several commentators have expressed concern about the ramifications of a judicially validated PPACA for attempts by the government, especially through the mechanism of Comparative Effectiveness Research (CER), to limit or ration particular forms of potentially beneficial medical care for some or all patients.