Ten years after the enactment of the Biologics Price Competition and Innovation Act (BPCIA), competition in biologics markets remains scant and far from sufficient for lowering prices of biologics to the level of 80-90% price drops seen in generic drug markets. This reality is not a result of one or two cardinal reasons, but many. If lowering the price of biologics is the goal and competition is the means by which we seek to achieve that goal, then there does not seem to be a quick fix to address all of the many impediments to competition that plague biologics markets. Yet, certain changes to how the Food and Drug Administration (FDA) evaluates and approves biologics may go a long way toward the creation of meaningful competition in biologics markets. One such change would be making original biologics' manufacturing information available to follow-on manufacturers.

As recognized by several commentators, access to biologics manufacturing information is key to increasing competition in biologics markets. Without access to such information, making follow-on biologics is difficult and expensive, if not outright impossible. This is expected to be especially true for the highly anticipated class of interchangeable biologics, none of which has been approved by the FDA to date. Yet, it has long been the position of the brand-name pharmaceutical industry (Industry) that biologics manufacturing information is proprietary and, thus, may not be shared. Congress has subscribed to the Industry's position, prohibiting the FDA from disclosing regulatory filings submitted by developers of original biologics, including manufacturing information, to third parties. That prohibition not only undermines competition in biologics markets, but is also wasteful, potentially unethical, and poses unnecessary risks to the health and safety of patients.

This article makes the case for FDA sharing of original biologics manufacturing information with follow-on biologics developers. It is informed by the similar legal and commercial circumstances in the area of pesticides and the regulatory regime established by Congress in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which is administered by the Environmental Protection Agency (EPA). The article reviews the FIFRA regime, including its upholding as constitutional by the United States Supreme Court, and then examines its applicability to the area of biologics. The article concludes with a proposal for a similar regime to be incorporated into the pathway for approval of follow-on biologics as a means of increasing competition in biologics markets.

This manuscript summarizes the most common barriers to effective administrative preparedness and how to surmount them through the use of promising practices, strategies, and NACCHO developed resources focused on addressing unique jurisdictional requirements and needs.

The United States wastes approximately 40% of its food supply. This article will examine the implications of this waste for food insecurity and climate change. It will also explore how the law and social entrepreneurship can be used to confront this public health challenge.

Many formerly incarcerated people have civil legal needs that can imperil their successful re-entry to society and, consequently, their health. We categorize these needs and assess their association with cardiovascular disease risk factors in a sample of recently released people. We find that having legal needs related to debt, public benefits, housing, or healthcare access is associated with psychosocial stress, but not uncontrolled high blood pressure or high cholesterol, in the first three months after release.

As of July 1, 2008, females aged 11-26 years seeking status as permanent residents in the United States must produce documentation that they have received the human papillomavirus (HPV) vaccine before the U.S. Citizenship and Immigration Services will approve their status adjustment. Immigration rights activists and public health officials have objected to this new requirement on the grounds that it is unnecessary and imposes unreasonable barriers to lawful immigration due to its expense. The Supreme Court has generally upheld mandatory vaccination requirements for citizens and non-citizens and has tolerated federal immigration regulations that would be unconstitutional if applied to citizens. However, the HPV vaccination requirement may be arbitrary, unnecessary, and discriminatory as applied to green card applicants who pose no greater threat to public health than citizens who are not subject to the same requirements. Furthermore, the requirement may also impose unreasonable restraints on aliens individual liberties as well as real barriers to immigration.

The power to change the natural environment has received relatively little attention in public health law, yet is a core concern within environmental and agricultural law. Examples from environmental and agricultural law may inform efforts to change the natural environment in order to reduce the health impacts of climate change. Public health lawyers who attend to the natural environment may succeed in elevating health concerns within the environmental and agricultural law spheres, while gaining new tools for their public health law toolbox.

On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (ACA or the Act) into law. ACA aims to improve access to care and health outcomes through a number of mechanisms, including requiring most individuals to carry health insurance, prohibiting insurers from denying health insurance coverage based on pre-existing conditions, and creating exchanges through which individuals and families not eligible for employer- or government-sponsored health insurance may purchase coverage. While the Act is aimed primarily at improving individual health by increasing access to health insurance, it also contains a number of provisions targeted directly at improving health at the population level. Most of these provisions, which encompass a variety of disease prevention and access-to-care initiatives, are found in ACA Title IV.

This article examines the past, present, and future of individual market policies in the Affordable Care Act (ACA). It does so, first, by reviewing the law's goals, scope, and set of individual market policies, collectively called the Health Insurance Marketplace. The Marketplace, along with the ACA's Medicaid expansion, was designed to fill in gaps to provide all Americans with accessible, affordable coverage. Second, it reviews evidence on the law's impact to date, including changes under a new administration. Third, it discusses the three main policy options for the Marketplace: do nothing, build on it, or replace it. Lastly, it discusses the factors which could determine which pathway policy makers follow.

The next steps in health reform, like all such efforts before it, will have to engage the issue of American health care federalism – the relationship between the federal and state governments in the realm of health law and policy. Since its enactment in 2010, the Patient Protection and Affordable Care Act (ACA) has offered a robust example of modern federalism and revealed new complexities. This article recounts the findings of our five-year study of the federalist and nationalist features of ACA implementation. Contrary to the claims of ACA opponents that the law marked a federal “takeover,” the ACA's governance structures have advanced rather than suppressed state power. But we also found that the advances in state power occurred seemingly independently of the statute's structural arrangements; that is, the ACA's nationalist and federalist features both enhanced state power over health policy. These findings raise questions about whether cherished American federalism values are unique to federalist structures; they also raise the question of what exactly health care federalism is for, and why we continue to design health policy with federalism front and center. It is not clear that enhanced state power has brought better health policy. If it has not, is federalism for its own sake worth the trade-off?

The 2024 U.S. election will shape the future of global health policy, with crucial implications for continuing U.S. leadership in global health. The United States has long played a critical role in global health governance, through multilateral institutions under the United Nations (UN) and bilateral assistance to advance U.S. priorities. However, political shifts have challenged U.S. engagement in global health, with the politicization of global health policy threatening global governance under the World Health Organization (WHO) and dividing global health support across political parties. This political polarization in global health proved catastrophic in the COVID-19 pandemic response and influential in the 2020 Presidential Elections. With the United States again seeking to advance global health policy, the 2024 Elections present a clear contrast in global health visions across U.S. political parties – with sweeping impacts on global governance, health funding, sexual and reproductive health, corporate regulations, tax equity, humanitarian challenges, and climate change. The future of U.S. leadership in global health hangs in the balance of this election, raising an imperative for candidates to highlight their global health positions and for voters to consider the global health implications.