You're currently on:

Back Issues and Articles
Back Issues and Articles

Table of Contents
Table Of Contents
ASLME - [PDF] (Free Download)
American Journal of Law & Medicine Volume 38, Numbers 4 * 2012 -Articles- 577 The Ethics of Postmarketing Observational Studies of Drug Safety Under Section 505(o)(3) of the Food, Drug, and Cosmetic Act. Barbara J. Evans - 607 Paying for Prevention: Challenges to Health Insurance Coverage for Biomedical HIV Prevention in the United States. Kristen Underhill - 667 Deficiencies of the FDA in Evaluating Generic Formulations: Addressing Narrow Therapeutic Index Drugs. Michelle Hottinger & Bryan A. Liang. -Notes and Comments- 690 When the First Amendment and Public Health Collide: The Court's Increasingly Strict Constitutional Scrutiny of Health Regulations that Restrict Commercial Speech. Samantha Rauer - 713 "Well Beyond" Permissible: How Severing the Leadership Act's Policy Requirement Affirms Our Commitment to First Amendment Values. David M. Ullian - 742 Letters to the Editor - 748 Recent Case Developments
Letters To The Editor
Letters to the Editor
ASLME - [PDF]

There are too many factual errors to count in Johanna Ferguson's article Cure Unwanted? Exploring the Chronic Lyme Disease Controversy and Why Conflicts of Interest in Practice Guidelines May be Guiding Us Down the Wrong Path - and the author unfortunately uses these errors to support misleading assertions about Lyme disease and the Infectious Diseases Society of America (IDSA). The implication that the physicians who wrote the IDSA's Lyme disease guidelines willingly stood in the way of a cure because doing so somehow benefitted them is offensive and outrageous.
Articles
The Ethics of Postmarketing Observational Studies of Drug Safety Under Section 505(o)(3) of the Food, Drug, and Cosmetic Act
Barbara J. Evans - [PDF]

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.
Paying for Prevention: Challenges to Health Insurance Coverage for Biomedical HIV Prevention in the United States
Kristen Underhill - [PDF]

Since the 1980s, the human immunodeficiency virus (HIV) has shaped both legal systems and population curves around the world, profoundly transforming law and public health. Much of the advocacy about HIV has focused on access to treatment, but recent scientific breakthroughs are prompting a new focus on access to prevention technologies. Although HIV prevention research has long focused on behavioral means of reducing infection (e.g., encouraging individuals to use condoms or sterile drug injection equipment), the past decade has brought about a shift toward biomedical strategies for prevention. This work is yielding promising, partially efficacious new methods for reducing the risk of infection, including the preventive use of antiretroviral (ARV) drugs as pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP), microbicide gels, vaccines, and adult male circumcision. Recent studies have also identified preventive effects of established technologies, such as ARV treatment for HIV-infected individuals, the treatment of other sexually transmitted infections (STIs), the treatment of substance use disorders, and HIV testing and counseling. Although individuals at elevated risk for HIV are often willing to use these interventions, many are unable or unwilling to pay the full cost of this medical care. But as mathematical models reflect, the public health impact of biomedical HIV prevention strategies will depend in part on their widespread adoption by individuals at risk. For this reason, the financing of biomedical prevention is likely to be a key question in the next phase of the U.S. response to HIV, and the costs of this care will interact with systemic priorities such as controlling healthcare costs and reducing the proportion of uninsured individuals.
Deficiencies of the FDA in Evaluating Generic Formulations: Addressing Narrow Therapeutic Index Drugs
Michelle Hottinger & Bryan A. Liang - [PDF]

Innovator drugs take years of research, clinical trials, and testing to pass the U.S. Food and Drug Administration (FDA) approval process, while generics must only pass bioequivalence (BE) tests to be deemed equivalent to the original product and safe for public use. Hence, if bioequivalent, generic drugs offer great promise to minimize costs and increase drug accessibility.
Notes and Comments
When the First Amendment and Public Health Collide: The Court's Increasingly Strict Constitutional Scrutiny of Health Regulations that Restrict Commercial Speech
Samantha Rauer - [PDF]

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 Vermontís 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.
"Well Beyond" Permissible: How Severing the Leadership Act's Policy Requirement Affirms Our Commitment to First Amendment Values
David M. Ullian - [PDF]

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. The physician hopes that her organization's policy will not stigmatize or alienate her new patient, but she is obliged to comply. If she does not, the physician risks losing the ability to help her new patient entirely.
Recent Court Decisions
Recent Case Developments: State Acquisition of Hospitals: Federal Court Finds Hospital Authorities Have State-Action Immunity to Engage in Anticompetitive Activity - Federal Trade Commission v. Phoebe Putney Health System, Inc.
Jeffrey Hoffman - [PDF]

On June 25, 2012, the Supreme Court granted the Federal Trade Commission's (FTC) petition for certiorari in the case of Federal Trade Commission v. Phoebe Putney Health System, Inc. The Court will review two issues: whether the Georgia legislature 'clearly articulated a... state policy to displace competition," thereby granting a state hospital authority state-action immunity from federal antitrust laws, and whether state-action immunity would be sufficient to validate the anticompetitive activity in this case given the hospital authority's lack of supervision over the transaction in question.
Recent Case Developments: California Medicaid Amendments: Supreme Court Vacates and Remands Supremacy Clause Private Right of Action Issue Based on Changed Conditions - Douglas v. Independent Living Center of Southern California
Lindsey Gabrielsen - [PDF]

The Supreme Court of the United States vacated a series of opinions by the United States Court of Appeals for the Ninth Circuit that allowed Medicaid providers and beneficiaries to maintain a cause of action against California state officials under the Supremacy Clause for allegedly failing to comply with federal statutory requirements of the Medicaid program when enacting amendments to their State Medicaid plan. The Court remanded the case to the Ninth Circuit to consider the implications of the Center for Medicare and Medicaid Service's (CMS) recent approval of the state amendments on the respondents' ability to sue under the Supremacy Clause.
Recent Case Developments: Federal Circuit Holds Isolated DNA Is Patent-Eligible - Association for Molecular Pathology v. United States Patent and Trademark Office (Myriad III)
Cong Yao - [PDF]

On August 12, 2012, after remand from the Supreme Court, the U.S. Court of Appeals for the Federal Circuit held that the following is patent-eligible: 1) isolated DNA; 2) a method claim for detecting germline/somatic genetic alterations by comparing DNA sequences; and 3) a method claim for screening cancer therapeutics by measuring transformed cells' growth rate.