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.

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.

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.

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.

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.