Given the profound public health and economic ramifications of decisions made by the U.S. Food and Drug Administration, the degree to which FDA activities should reflect an approach founded on complete transparency versus one focused on preserving confidentiality of information deserves public discussion. On one hand, reasonable requirements for transparency are critical to stimulating effective innovation, knowledge dissemination, and good business practice. On the other, ensuring the vitality of the medical products industry requires protecting legitimately proprietary information. With current standards reflecting a lengthy accumulation of legal, regulatory, and practical precedent, recent significant changes in the environment in which the FDA operates should prompt a critical examination of current practices. In this article, I comment on Sharfstein and colleagues’ “Blueprint for Transparency,” which calls for multiple specific actions to increase transparency at the agency across five key areas, including interactions between FDA and industry, public disclosure of internal FDA analyses, deliberations concerning generics and biosimilars, expanded access to raw study data, and approaches to countering misleading information in the public sphere. I evaluate these recommendations in light of my experience as a clinician, researcher, and former FDA Commissioner, and reflect on possible outcomes that could result from enacting these practices.

In Pacificare Health Systems, Inc. v. Jefrey Book, the US. Supreme Court ruled that the mandatory arbitration clause in an HMO contract should be enforced to compel a physician to arbitrate his RICO charges against the health plan, even though the clause could be construed to limit the arbitrator’s authority to award full damages under the RICO statute. The ruling could prevent physicians with health plan arbitration agreements from taking future reimbursement claims against insurance companies directly to court, even when the allegations involve a potential statutory breach outside of the explicit scope of the provider contract.

Dr. Book’s arbitration claim was part of a larger class action lawsuit filed in August of 2000 by a group of physicians and patients seeking reimbursement from eight managed care companies for unpaid health insurance claims.

Following the tragic shootings in Newtown (Connecticut), Aurora (Colorado), Isla Vista (California) and others, increased national attention has focused on the relationship between mental illness and gun violence. While some have called for enhanced regulation of firearm possession by persons with mental illness, others have argued that such actions would be ineffective and enhance stigma associated with mental illness while discouraging treatment seeking.

The National Summit on Legal Preparedness for Obesity Prevention and Control was conceived by the Centers for Disease Control and Prevention (CDC) as a strategic conference to review the current status of legal preparedness for obesity prevention and control, identify potential gaps, and develop specific action options for improving the contribution law can make to reduce the health threat posed by obesity. Working with the collaborating partners and planning committe, the host committe planned and modeled after the Summit CDC’s 2007 conference on public health emergency legal preparedness that resulted in the National Action Agenda for Public Health Emergency Legal Preparedness. The summit was a working meeting that offered invited participants a structured opportunity to deliberate about the laws and legal issues that impact obesity prevention and control from a public health perspective.

Firearm violence is a major public health problem in the United States. In 2000, firearms were used in 10,801 homicides – two-thirds of all homicides in the U.S. – and 533,470 non-fatal criminal victimizations including rapes, robberies, and assaults. The social costs of gun violence in the United States are also staggering, and have been estimated to be on the order of $100 billion per year.

Illegal gun carrying, usually concealed, in public places is an important risk factor for firearm-related crime. In the 1980s and 1990s, police departments across the country began to develop and implement strategies to address illegal weapons carrying. Often these strategies have involved aggressive efforts to identify and physically search individuals suspected of illegally carrying a firearm.

Recent guidelines and recommen dations from government prevention advisory groups endorsing shared clinical decision-making reflect an emerging trend among public health bodies.

It is commonly said that patients (or their representatives) have no right to demand that treatment must be continued when medical carers believe it is “futile” to continue it. There are certainly many judicial statements to this effect, some of which are quoted in this paper. However, there are various ways that courts can intervene, even if they do not order directly that treatment must be provided or continued. First, patients or their representatives may argue the process of decision making was unfair or that they were unfairly discriminated against when treatment has been refused. To date, these arguments have met with limited success so far as enabling patients to have treatment provided or continued against medical advice. More recently, however, some patients have challenged the lawfulness of a proposed treatment regime by advancing human rights arguments, based in turn on a broader aspect of patients’ “best interests” than best medical interests.

Markets have long had a whiff of sulphur about them. Plato condemned innkeepers, whose pursuit of profit he believed led them to take advantage of their customers, Aristotle believed that the pursuit of profit was indicative of moral debasement, and Cicero held that retailers are typically dishonest as this was the only path to gain. And even those who are more favorably disposed towards markets in general are frequently inclined to be suspicious of markets in medical goods and services. For example, Margaret Thatcher (to take someone far removed — in many respects! — from Plato, Aristotle, and Cicero) supported the legal prohibition of markets in kidneys despite being arguably the most pro-market Prime Minister the United Kingdom saw in the 20th century.

The confluence of racial unrest and Medicaid expansion in Virginia should inspire a national reimagining of how health care can contribute to health equity. Hospitals in particular can leverage their role as economic drivers in communities to equalize health and social outcomes for all. The urgent need for innovative opioid intervention presents a fertile proving ground for new ways that hospitals can act to reduce the impact of racial inequity. Inspired by the role hospitals played to achieve desegregation during the Civil Rights era, this essay proposes an integrated approach to use Medicaid expansion to advance health and racial healing in America.

Bicycle helmets protect against head injury. Mandatory helmet laws likely increase their use. Although 21 states and Washington, DC have mandatory helmet laws for youth (variously defined) bicyclists, no U.S. state has a mandatory helmet law that applies to all ages; however, some localities have all-age helmet laws for bicyclists. This study abstracted local helmet laws applicable to all-ages to examine their elements.

Physicians’ resistance to implementing innovative medical procedures due to a perceived risk of liability can adversely affect the public’s health. This resistance prevents public access to procedures that could better treat communicable or chronic diseases. Innovative procedures, for the purpose of this article, are medical practices that require physicians to modify current clinical approaches to treating or diagnosing a patient’s condition and incorporate: (1) newly developed tests, treatments, drugs or devices (e.g., genetic screening to identify drug sensitivities to reduce adverse drug reactions); or (2) novel methods not commonly used by a majority of physicians (e.g., partner delivered therapy to treat an intimate partner for a communicable disease or advanced prescription of naloxone to patients prone to an opioid overdose). Innovative procedures do not include treatments provided during clinical research or those beyond a physician’s scope of practice.