Amanda Jackson, MJLST Staffer
As the novel coronavirus, COVID-19, continues its global rampage, the United States has been hard hit. Now third with respect to number of new cases, there is little evidence to show that the case count will decrease any time soon. If Italy provides any indication of what is to come, the United States is only going to be hit harder by the life-threatening virus. Both federal government and local governments have taken drastic measures to combat the spread of COVID-19, including state-wide shelter-in-place orders, closing schools and universities, banning dining in at bars and restaurants, and moving non-essential businesses to work-from-home models.
As the confirmed cases continue to rise, so does uncertainty and uneasiness among the nation and the world as a whole. What will fix this crisis? How long will these measures be in place? How many more people will get sick and potentially pass away from the virus? What will happen to the economy? Will my loved ones be okay? The questions never seem to end. Luckily, however, there are some answers as to how different laws, administrative agencies, and regulations in place in the United States can aid in the fight against the quickly spreading coronavirus.
First, the Defense Production Act (DPA) can alleviate shortages in medical equipment. As concern about the novel virus itself grows, concern for the availability of necessary supplies and equipment also seems to grow at record speeds. A lack of masks and other personal protective equipment for healthcare workers, a shortage in ventilators and beds for sick patients, and even a need for healthcare workers and hospital space are becoming more prevalent as the COVID-19 crisis continues. The DPA, a Korean War-era law, enables the federal government to require private companies to provide for the needs of national defense. The DPA may not be able to satisfy the need for healthcare workers and hospital space, but it can allow the federal government to direct manufacturers to produce the desperately needed medical equipment for healthcare workers and patients. However, the President must invoke the DPA in order for it to make a difference, and as of right now, the DPA has not been invoked to aid in the fight against coronavirus. Although some companies have increased or altered production to help restock the necessary equipment, it remains unclear whether that alone, without invoking the DPA, will be enough to meet the needs of the United States in the coming weeks. Even so, the DPA provides a robust option to fulfill the needs of the nation in the fight against the pandemic.
Second, the Federal Drug Administration’s (FDA) and the National Institute of Health’s (NIH) ability to fast track vaccines and therapeutic drugs can speed up development of a COVID-19 vaccine or therapy. Called an Emergency Use Authorization (EUA), the FDA is able to authorize emergency use of an unapproved product or an unapproved use of an approved product under a declaration of a public health, domestic, or military emergency, or a material threat. The evidence required for approval of an EUA is that the product “may be effective” to treat, diagnose, or prevent the conditions associated with the declaration. This is a lower standard than the “effectiveness” standard used for typical FDA approvals, a process that takes on average twelve years to go from a new drug in a laboratory to a drug on a pharmacy shelf. In determining whether to approve the EUA, the Commissioner has to determine that the known and potential benefits of the product outweigh the risks associated with the product, while also considering the threat prompting the emergency declaration. Fortunately, the FDA has already issued multiple EUAs with respect to the novel coronavirus, such as for tests to detect COVID-19. The FDA has also instituted flexible measures outside of EUAs that enable states to take a more prominent role than typically allowed. For example, the FDA is now allowing states to approve COVID-19 tests without requiring FDA approval or an EUA. Moreover, NIH is also fast-tracking development of a coronavirus vaccine, with a Phase I clinical trial of the vaccine candidate having already begun.
Third, declarations of major disaster areas will open up emergency funds to help states and local governments respond to an outbreak. Major disaster area declarations are often requested when a disaster exceeds the response capabilities of state and local governments under extremely severe circumstances. Major disaster area declarations enable a wide range of federal assistance for both individuals and public infrastructure. With respect to coronavirus, the President has already declared New York and other hard-hit states as major disaster areas, the first time in United States history that a major disaster has been declared for a public health threat. The declaration enables the federal government to pay for a majority of the states’ costs and mobilize the Federal Emergency Management Agency (FEMA) to deploy assistance in the state, among other methods of assistance.
Fourth, shelter-in-place orders by local governments may reduce the spread of the virus. Shelter-in-place orders mandate that residents stay in their homes, except for essential trips (e.g., to the grocery store or a pharmacy). Many shelter-in-place orders also force all non-essential businesses to close. These orders are generally constitutional under a state’s police power. At least eight states and many cities have issued shelter-in-place orders as a means to flatten the curve and reduce the impact of coronavirus on society and the healthcare system. Some law enforcement officials appear to be taking the orders very seriously, breaking up parties in violation of the shelter-in-place rules or stating that the orders will be “strictly enforced.”
Moreover, there are multiple bills working their way through the federal government that will hopefully provide some more answers and relief for the American people. Although those options are only a few of the tools in the government’s toolbox, if used properly, they can help the nation combat COVID-19.