Regulation of Molecular Diagnostics.

Molecular diagnostic tests enable rapid analysis of genomic and proteomic markers. These tests are subject to diverging premarket access and postmarket surveillance requirements and mechanisms in the United States and the European Union. Each of these jurisdictions has its own challenges in keeping the regulations up to date with technological developments. A specific area of attention is that of laboratory-developed tests in the United States and health institution in-house-produced tests in the European Union, for which the United States and the European Union have markedly different regulatory approaches. Both jurisdictions have specific but differing requirements for the use of test samples and test-related data under their rules regarding the protection of (personal) health data, which can cause complexity when moving samples or sample-related data from one jurisdiction to the other.

Who's on third? Regulation of third-party genetic interpretation services.

In recent years, third-party genetic interpretation services have emerged to help individuals understand their raw genetic data obtained from researchers, clinicians, and direct-to-consumer genetic testing companies. The objectives of these services vary but include matching users to genetic relatives, selling customized diet and fitness plans, and providing health risk assessments. As these services proliferate, concerns are being raised about their accuracy, safety, and privacy practices. Thus far, US regulatory agencies have not taken an official position with respect to third-party genetic interpretation services, which has caused uncertainty regarding whether and how they might be regulated. To clarify this area, we analyzed their potential oversight by four US agencies that generally have been active in the regulation of genetic testing services and information: the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the Department of Health and Human Services' Office of Civil Rights, and the Federal Trade Commission. We conclude that the scope of federal jurisdiction over third-party genetic interpretation services-while limited-could be appropriate at this time, subject to agency clarification and appropriate exercise of oversight.

Regulation of next generation sequencing.

Next generation sequencing raises new questions within the context of an existing and still evolving regulatory landscape for device manufacturers and clinical laboratories. FDA cleared the first NGS sequencing platform in November 2013, but it is unclear what lies ahead for this technology. NGS will require new types of training and expertise to interpret the vast quantities of genetic data so as to provide meaningful clinical information to physicians and patients. This paper will describe the current regulatory landscape for NGS technologies, identify the regulatory challenges they present, and consider whether new regulatory paradigms are needed to accommodate NGS technologies and services.

Take another little piece of my heart: regulating the research use of human biospecimens.

This article reviews the history of the debate over use of biospecimens in research, the legal and ethical arguments that have been presented both in support of and in opposition to such use, court cases and judicial opinions involving disputes between specimen contributors, researchers, and institutions, and public attitudes regarding the use of biospecimens in research. The paper argues that proposed changes to the Common Rule are inadequate to resolve the legal and ethical concerns that have been raised with respect to the use of biospecimens. It argues that there is a need to distinguish between the dual roles - subject and donor - played by contributors of biospecimens.

Pink or blue? The need for regulation is black and white.

A new direct-to-consumer genetic test purports to detect fetal gender as early as five weeks of pregnancy. The availability of this test highlights the consequences of the current system of oversight for genetic tests and underscores the need for an enhanced regulatory framework to ensure the accuracy, reliability, and validity of genetic tests.

Policy implications of genetic testing: not just for geneticists anymore.

Genetic testing is expanding rapidly to become part of mainstream medicine. While genetic tests bring with them the promise of improved diagnosis and treatment for patients, they also raise several policy challenges. These challenges include the lack of a coherent oversight system to ensure the quality of tests and testing laboratories, the rise of direct-to-consumer genetic testing, the dearth of professional guidelines to assist the transition of genetic tests from research to medical practice, and the absence of federal legislation to protect the privacy of genetic information and prevent genetic discrimination.

Regulating (for the benefit of) future persons: a different perspective on the FDA's jurisdiction to regulate human reproductive cloning.

The Food and Drug Administration (FDA) has taken the position that human reproductive cloning falls within its regulatory jurisdiction. This position has been subject to criticism on both procedural and substantive grounds. Some have contended that the FDA has failed to follow administrative law principles in asserting its jurisdiction, while others claim the FDA is ill suited to the task of addressing the ethical and social implications of human cloning. This Article argues, that, notwithstanding these criticisms, the FDA could plausibly assert jurisdiction over human cloning as a form of human gene therapy, an area in which the FDA is already regarded as having primary regulatory authority. Such an assertion would require that the FDA's jurisdiction extend to products affecting future persons, i.e., those not yet born. This Article demonstrates, for the first time, that such jurisdiction was implicit in the enactment of the 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act and that the FDA has historically relied on such authority in promulgating regulations for drugs and devices.

Tobacco advertising in the United States: a proposal for a constitutionally acceptable form of regulation.

Lorillard Tobacco Co. v Reilly is the latest in a series of Supreme Court cases striking down public health regulation of advertising as a violation of the First Amendment. In its decision, the Supreme Court significantly reduced the scope of constitutionally acceptable forms of regulation of tobacco advertising and created an almost insoluble dilemma for public health authorities. Control over advertising, along with taxes and restrictions on smoking in public settings, plays an important role in the public health response to tobacco. Those committed to reducing the patterns of cigarette-related morbidity and mortality should broaden their advertising-related strategies and consider the role that greater disclosure of the health harms of tobacco can have on reducing consumption. Toward this end, we propose a comprehensive system of taxation and regulation designed to increase public appreciation and comprehension of the health risks of cigarettes. First, we consider a tax to be levied on tobacco advertising and promotion or, as an alternative, a new excise tax, the proceeds of which would be used exclusively to fund a Centers for Disease Control and Prevention-directed national antitobacco campaign. Second, all print advertising should be required to carry public health warnings equivalent to 50% of the space devoted to the advertisement. Third, manufacturers should be required to devote one full side of cigarette packages to graphic pictorials displaying the dangers of smoking. The tobacco industry would no doubt respond by declaring such efforts an unwarranted burden, an example of constitutionally suspect compelled speech. However, this would be a battle worth engaging, because it might have an impact on tobacco-related morbidity and mortality in the United States.