Scope of CDC Authority Under Section 361 of the Public Health Service Act (PHSA)

"Since the beginning of the Coronavirus Disease 2019 (COVID-19) pandemic, all levels of government have grappled with how to stem the spread of the disease. Until the recent authorization of several COVID-19 vaccines, community mitigation activities (such as social distancing and use of face covering), combined with traditional tools of communicable disease control(such as testing, contact tracing, quarantine, and isolation)—have been the primary strategies used to reduce or prevent COVID-19 transmission.

Under the United States’ federalist system, states and the federal government share regulatory authority over public health matters, with states traditionally exercising the bulk of authority in this area. Consistent with this framework, states and localities have been at the leading edge of the United States’ pandemic response in many respects. For instance, to varying degrees, they issued mandates aimed at promoting the relevant public health measures, including temporary stay-at-home orders, restrictions on public gatherings, requirements to wear face coverings under specified circumstances, and quarantine requirements for out-of-state travelers. Because adherence to some of these measures—particularly ones that place restrictions on business operations—resulted in income losses for their residents and businesses, states have also issued orders aimed at alleviating the pandemic’s associated economic impact. For example, many states temporarily halted evictions or provided other housing support to assist households that have experienced pandemic-related income losses that rendered them unable to pay rent. The federal government’s pandemic response to date includes providing support to states through guidance, technical assistance, and funding, as well as providing certain direct assistance to private entities and individuals, including through several pandemic relief legislations.

The scale and nature of the pandemic have prompted some commentators to call for the imposition of public health orders at the federal level. In their view, coordinated federal action, rather than a patchwork of state-level orders, is the more effective approach to addressing COVID-19, given that the virus that causes COVID-19 is highly transmissible and can cause serious illness in some people. Commentators have considered whether Section 361 of the Public Health Service Act (PHSA) could serve as a source of authority for such federal executive action. Section 361 authorizes the Secretary of Health and Human Services (HHS Secretary)—who, in turn, delegated the authority to the Centers for Disease Control and Prevention (CDC) and the U.S. Food & Drug Administration (FDA)—to issue regulations “necessary” to prevent the foreign and interstate spread of communicable diseases

In September 2020, the CDC—in the broadest invocation of its Section 361 authority to date—issued an order that nationally halted residential evictions for certain tenants under specified conditions. The CDC concluded that this eviction moratorium was necessary to prevent the interstate spread of COVID-19 because evictions could lead a sizeable portion of the population to become homeless or to relocate to new congregate living situations that increase the risk of COVID-19 transmission. The CDC’s order—which could be characterized as both a public health and an economic regulation—could raise larger questions about the scope of agency authority under Section 361, including the CDC’s authority to implement transmission control measures that have broader economic implications...."
CDC Authority 

Legal Issues in COVID-19 Vaccine Development

"Private companies, universities, and governmental entities are working to develop a vaccine for coronavirus disease 2019 (COVID-19). Vaccines are biological products regulated under the Public Health Service Act (PHSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). New vaccines must generally be licensed by the U.S. Food & Drug Administration (FDA) before they can be marketed and used in the United States. To obtain licensure, the vaccine must be tested in human subjects through clinical trials. The clinical trials inform the dosing schedule and labeling that will be used for the approved vaccine. Sponsors use the data from clinical trials, along with other information, to prepare a biologics license application (BLA) to submit to FDA. FDA approves the BLA if it determines that the vaccine is safe, potent, and pure.

Because the development and review process can be lengthy, the FD&C Act provides several avenues to accelerate this process for pharmaceutical products intended to treat or prevent serious diseases or conditions. FDA may grant fast track product and breakthrough-therapy designation at the sponsor’s request for products that are intended to fill an unmet need or improve on existing therapies. Both designations entitle the sponsor to increased communication with FDA regarding the clinical trial design and data collected, as well as rolling review of the BLA. Products may also qualify for accelerated approval based on intermediate or surrogate endpoints likely to predict a clinical benefit. In addition, FDA may designate products for priority review..."
COVID-19 Development