The pre-emption doctrine as applied to food and drug law argues that manufacturers whose products gain Food and Drug Administration (FDA) marketing approval are immune from tort liability in state court solely on the basis of their FDA approval. This pre-emption protection applies both to claims of direct damages caused by the product and as well as indirect (failure to warn/labeling) damages claims.

The recent 8-1 U.S. Supreme Court decision in Riegel v. Medtronic, Inc. upheld the manufacturer’s contention that the pre-emption provision in the 1976 Medical Device Amendments of 1976 (MDA) to the 1938 Federal Food, Drug and Cosmetic Act (FDCA) completely precluded civil damages suits by injured plaintiffs in state court. Justice Ginsburg was the lone dissenter.

The Genetic Privacy Act (GPA) is a comprehensive effort to protect individuals from unauthorized analysis of their DNA and from unauthorized disclosure of information resulting from genetic analysis. Irrespective of merit, every bill must survive legislative scrutiny. This is a considerable challenge, particularly for a bill as complex and far-reaching as the GPA. To illustrate my point, I describe the fate of two bills introduced into the Maryland Senate in 1995 by Senator Jennie Forehand. The first, also entitled the Genetic Privacy Act (S. 645), was a slightly modified version of the model legislation prepared by Annas, Glantz, and Roche. After a hearing, the bill received a 9-2 unfavorable vote from the Economic and Environmental Affairs Committee. The second was a much shorter bill, DNA Testing – Informed Consent and Confidentiality (S. 707), which simply stated that “DNA analysis may only be performed with the informed consent of the person being analyzed” and that the results of such analysis “are the exclusive property of the person tested, are confidential, and may not be disclosed without the consent of the person being tested.” This bill had a hearing but was never put to a vote by the Judicial Proceedings Committee. My principal aim is to examine the testimony on these bills. I will conclude with some suggestions about accomplishing the goals of genetic privacy legislation.

In the pediatric clinical setting, the parent/guardian will almost always be the authorized representative and designated recipient of clinical and research results, making the issue of to whom results should be returned in the pediatric setting less complex than in adult settings. It is also clear that, in genomic research related to pediatric diseases such as cancer, results may be of considerable clinical, ethical, and personal significance for parents in a number of ways, including a genomic explanation of the origin of their child’s cancer, implications for the genetic testing and medical care of other siblings and of the parents themselves, and reproductive planning with regard to the recurrence risk for future children to have an increased risk of cancer. However, what remains unclear is which results should be disclosed, and under what circumstances, to parents of deceased children.

Whether research results should be returned to participants has been an ongoing debate in the research and bioethics communities for years. The debate has become more complicated as advances in technology permit the discovery through genomic sequencing of a growing number of findings that may or may not have clinical relevance for research participants. As part of the larger conversation regarding whether and under what circumstances research results should be returned to participants, research conducted using residual newborn screening dried blood samples (DBS) deserves special consideration due to the nature of newborn screening, the recent controversy regarding the retention and use of DBS, and the impact of this controversy on state newborn screening programs.

Sujatha Jesudason and Tracy Weitz provide an empirical examination of the framing of public discourses related to assisted reproductive technology (ART) and abortion by examining two bills considered by the California legislature in “Eggs and Abortion: The Language of Protection in Legislation Regulating Abortion and Egg Donation in Debate over Two California Laws.” Jesudason and Weitz analyze the framing of two different legislative efforts: one allowing non-physician practitioners to perform non-surgical abortions and the other removing the prohibition on egg donor payment in the research setting. Jesudason and Weitz identified three different memes that were present in the discussion of these two bills: health care providers and scientists as inherently suspect, denial of women of agency through speaking about them as passive actors that things happen to, and the focus on potential harms and the need to protect women from harm. What was most compelling about their article is that they convincingly show how these themes were used as political tools by both anti-choice and pro-choice groups in California. Jesudason and Weitz note that “frames and language matter.”

The discovery of the molecular structure of deoxyribonucleic acid (DNA) and the science of molecular biology have profoundly changed medicine’s diagnostic capability and promise to transform the therapeutic realm. When some genetic disorders are diagnosed, physicians can intervene for prevention or treatment. While the basic structure of DNA is the same for all human beings, no two individuals, other than identical twins (or cloned individuals), have the same DNA sequence. This discovery has had important repercussions in the criminal justice system, where DNA can serve as an identification tool.

At the crossroads of these different uses of DNA, there are great concerns about potential misuses of genetic information. Preventing disease, curing illness, and convicting criminals are all seen as worthwhile uses of the technology, but concerns of potential misuse in medicine or in the criminal justice system are not unfounded. A 1998 American Medical Association (AMA) study showed that 68 percent of patients had fears that their genetic test results would be used against them by their employers or insurers. Others, pointing to racial profiling, have suggested that we may now face genetic profiling.

This essay critiques the fiercely utilitarian allocation scheme of Cameron et al. Children have no hope of recovery if their lives are cut short based on administrative protocols that misrepresent the nature of their conditions. Unilateral futility judgements - especially those based on a false predicate - are discriminatory. When considering the best interests of children, we should see possibility in disability and not advance ill-informed utilitarianism.

The Occupational Safety and Health Administration (OSHA) issued an emergency temporary standard (ETS) for COVID-19 applicable to private sector employers with 100 or more employees. Among other things, the ETS required employers either to mandate employee vaccination or weekly testing and wearing masks.

Health care costs and affordability are critical issues to consumers. Just as we assess the coverage impacts of a health reform proposal, we should be able to evaluate how the plan will constrain health care costs: its theory of cost control. This essay provides a framework to assess health reform plans on their theories of cost control, identifying the key policy tools to constrain health care costs organized in a two-by-two matrix across the following dimensions: price vs. utilization and public vs. private payers. It then applies the framework to the Affordable Care Act (ACA) and the Republican's 2017 legislative efforts to repeal and replace the ACA to identify their general theories of cost control, revealing on the plans' strengths, blind spots, and incoherence.

In recent years, the government, advocacy organizations, the press, and the public have pressured universities, academic medical centers, and physicianinvestigators to do more to ensure that their financial interests and relationships do not conflict with their duties to conduct high-quality research and protect the safety and welfare of clinical trial participants. A number of factors underlie the increased focus. First, private sector funding of clinical research has grown both in absolute terms and as a proportion of overall funding. In 2008, the pharmaceutical, medical device, and biotechnology industries’ domestic research and development expenditures constituted approximately 60.9% of funding for biomedical research in the United States; the next largest funder, the National Institutes of Health, funded 27.9%. Private industry spent $58.6 billion on research in 2007, up from $40 billion in 2003, an increase of 25% after adjusting for inflation.

A typical discussion around health reform in the U.S. focuses on how the nation can most effectively and efficiently extend insurance coverage to the rising number of people who have none. Furthermore, discussions about health care reform typically are centered on times of normalcy, when the health care system is not overly taxed and there is the luxury of time to think about everyday matters of health and health care, including health care services needed to prevent illness, treat conditions, and address individual emergencies. But in light of the lessons learned over the past decade, it is also essential to consider how any reformed health care system will react to and mitigate the consequences of a public health emergency.

In recent years a number of commentators have discussed the importance of measuring quality of life (QL) in health care. We want to know whether an intervention will help people to live better, not just longer, and whether some treatments cause more trouble than they are worth. New technologies promise wondrous benefits. But when millions of people have no insured access to health care, and when many others face increasingly stringent limits on care, technologies’ high costs require us to choose what we should do from the broader universe of what we can do.

The challenges to measuring QL are formidable. Researchers debate whether to measure general QL or disease-specific QL; whether to focus on functional status such as the patient's ability to walk and dress himself, or on the value people ascribe to that functional status; whether to seek the values of the general public, or to concentrate on people actually affected by a given disease or disability.

In recent years, courts have increasingly found them-selves arbiters of disputes in the emotionally charged area of assisted reproductive technologies. Legal disputes are hardly surprising in the world of infertility medicine, where millions of patients spend billions of dollars in efforts to have a child. Increasingly, these efforts produce embryos that are frozen for later use, at once maximizing a couple's chances for success and minimizing the medical intrusiveness that necessarily accompanies most forms of assisted reproductive technologies. But with over 100,000 embryos in frozen storage in the United States and a divorce rate of 40 to 50 percent, it is not surprising that disputes over the disposition of these embryos are arising, causing the legal landscape surrounding these technologies to continue to expand.

Toronto physician Brian Goldman had thought about “joining the camp that favours private health care for Canada.” Writing in the Canadian Medical Association Journal, he tells us that he changed his mind after one of his cats experienced a series of illnesses and misadventures that resulted in a Can$3,101 medical bill. “I’m just glad,” he says, “that the cost of health care never entered my deliberations.”’

Canadian citizens and permanent residents are similarly free from most worries about the direct costs of their own medical care, and have been for more than a generation. This reflects a fundamental difference between the Canadian and United States contexts for health policy. Since the failure of President Clinton's first-term efforts to provide something approximating universal health insurance, reforms to the existing regime of providing and financing health care in the United States have been incremental, and primarily responsive to the changing nature of the health care marketplace. In Canada, universal publicly funded first-dollar coverage for most physicians’ and hospitals’ services has been a reality since the early 1970s.

Developing countries are faced with the mutually perpetuating obstacles of poverty and inadequate development. Their needs are often so vast that their scarce resources prove too meager even to begin to address the problems.

It is estimated that close to 2.2 billion people live in a state of severe poverty. The precarious housing and health of these people, 60 percent of the population of developing countries, are compounded by hunger and dangerous environmental conditions. Generally, they have large families and their incomes are extremely low. Malnutrition is widespread despite the fact that 80 percent of their earnings are spent on food.

Much of the human research conducted in the United States or by U.S. researchers is regulated by the Common Rule. The Common Rule reflects the decision of 17 federal agencies, including the Department of Health and Human Services (whose regulations appear at 45CFR46), to require that investigators follow the same rules for conducting human research. (The Food and Drug Administration [FDA] has its own rules (at 21CFR50 and 21CFR56), though there is significant overlap with the Common Rule.) Many of the obligations delineated in the Common Rule can be traced back to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (hereafter the National Commission). The National Commission was appointed in 1974 as part of the National Research Act (P.L. 93-348) in response to revelations about serious abuses involving human subjects, most notably the Tuskegee/United States Public Health Service Syphilis Study.

The events of September 11, 2001 have prompted significant concern to protect against future terror attacks, especially attacks that would involve the use of biological weapons - the most dangerous weapons of massdestruction considered accessible to terrorist groups and organizations. This concern, in turn, has led to a re-evaluation of the public health system and its preparedness to meet the challenges of treating a large number of people in circumstances of public fear and significant demand for resources. One important result of this re-evaluation has been the development of a Model State Emergency Health Powers Act (MSEHPA) that is designed to grant state officials the authority necessary to coordinate an effective response to biological tenor. The Model Act was first publicized in late October, 2001,and a revised version was publicized December21, 2001.As of October 1,2002,legislation based on the Act had been introduced in thirty-six states, and versions of the Act had been enacted in twenty states and the District of Columbia.