While humans may be the most sophisticated and capable species on planet Earth, we are still subject to a strong dose of humility now and again. We humans must accept that there are certain things we have limited control over. One of these things is the spread of disease.
Due to scientific and medical innovations, many bacterial diseases that once plagued the world are no longer the threat they once were. The discovery of antibiotics in the first half of the 20th century dramatically decreased the risk of death from diseases such as pneumonia, tuberculosis, gonorrhea, or rheumatic fever.[1] Unfortunately, the same innovation has not yet occurred with viral illnesses. Unlike bacteria, viruses are unimpacted by antibiotics.[2] While vaccines can help prevent or minimize the effect of a virus,[3] doctors have limited remedies outside of rest, fluids, and over-the-counter medications.[4] Antiviral medications do exist, but they are limited to certain illnesses and only inhibit the viruses’ ability to reproduce.[5] Our inability to cure viral infections, coupled with the amount of time it takes to create new vaccines, make new viruses very hard to control.[6]
In December 2019, a new virus emerged called the novel coronavirus (“COVID-19”). At the time this article was written, over 95,000 people have been infected and 3,254 have died due to the virus.[7] While most cases of COVID-19 are in Asian countries such as China, South Korea, and Japan, the virus is beginning to spread into the United States.[8] As of March 4, 2020, 153 people have been infected in the United States and eleven have died.[9] The World Health Organization has warned that the outbreak has reached the “highest level” of risk for the world,[10] and the Center for Disease Control warned, “[i]t’s not so much a question of if this will happen anymore but rather more a question of exactly when this will happen and how many people in this country will have severe illness.”[11] As COVID-19 steps foot in the United States, it may be helpful to review what exactly a pandemic is, and what power the Federal government has to combat one.
The CDC defines an epidemic as a sudden increase in the number of cases of a disease above what is normally expected in that population in that area.[12] A pandemic is defined as an epidemic that has spread over several countries or continents, usually affecting a large number of people.[13] The CDC uses three criteria in designating a pandemic: (1) the disease spreads between people, (2) the disease kills, and (3) the disease spreads worldwide.[14] At the time this article was written, the CDC had recognized that COVID-19 met the first two criteria and is quickly moving towards meeting the third.[15] As the coronavirus moves closer to becoming a pandemic, there are many laws and regulations that may apply to the federal government’s response.
- Public Health Service Act
The Public Health Service Act (“PHSA”) gives the U.S. Department of Health and Human Services (“HHS”) broad authority to respond to public health emergencies. Most notably, the act gives the secretary of HHS the ability to declare public health emergencies.[16] In the case of a disease, the Secretary only needs to consult with public health officials as may be necessary to declare an emergency.[17] Once the Secretary determines that a public health emergency exists, she may make grants, provide awards for expenses, enter into contracts, and conduct investigations into the cause, treatment, or prevention of the disease causing the emergency.[18]
Additionally, the act establishes a Treasury fund designated as the “Public Health Emergency Fund” which the Secretary may use to rapidly respond to a public health emergency.[19] The PHSA allows the Secretary to use this fund to facilitate coordination between federal, state, local, tribal, and territorial jurisdictions.[20] It also allows the Secretary to make grants, provide awards, enter into contracts, conduct investigations, facilitate research, strengthen bio surveillance capabilities, support initial emergency operations, and carry out any other activity the Secretary determines is appropriate.[21] The broad authority given to HHS by this statute allows for a coordinated and centralized response in the case of a pandemic.
The PHSA also establishes the National Disaster Medical System (NDMS).[22] The NDMS is a coordinated effort by HHS, the Department of Homeland Security, the Department of Defense, and the Department of Veterans Affairs to combat public health emergencies.[23] During a pandemic or other public health emergency, the Secretary can activate NDMS to provide health and human services to victims.[24] The Secretary also has the ability to ensure NDMS is present at certain locations for limited periods of time based on a determination that such location is at risk of a public health emergency. Structurally, the PHSA gives the Secretary of HHS great authority over the coordinated effort of several Federal agencies. In this sense, it recognizes the need for efficient decision making in cases of public health emergencies.
The PHSA also allows the Secretary to enhance medical surge capacity.[25] In order to increase surge capacity, the Secretary may acquire, deploy, and operate mobile medical assets and work with other agencies to identify federal buildings and facilities from which health services may be administered in the case of emergency.[26] This allows the Secretary to use federal buildings and mobile units to administer care to infected people and relieves some of the hospital crowding caused by a widespread disease.
Finally, the PHSA allows the Secretary of HHS to take measures to prevent the entry and spread of communicable diseases from foreign countries and between the states.[27] HHS has interpreted this statute to allow for the CDC to detain and medically examine people arriving into the U.S. and travelling between states who are suspected of carrying communicable diseases.[28] The director of the CDC can authorize the apprehension, medical examination, quarantine, isolation, or conditional release of individuals to prevent the spread of disease.[29] This means consent is not required for the government to quarantine you from others. But have no fear! If you are quarantined under this section, the Director must arrange for your food and water, accommodations, medical treatment, and methods of communication.[30]
- Robert T. Stafford Disaster Relief and Emergency Assistance Act
The Robert T. Stafford Disaster Relief and Emergency Assistance Act allows the President to do several things when facing a pandemic. First, the President may declare an emergency at the request of a state or other jurisdiction if an emergency is beyond the state or other jurisdiction’s response capabilities.[31] Second, the Stafford Act allows the President to declare a national emergency without a gubernatorial request if the primary responsibility for the response rests with the federal government and the emergency involves an area that the federal government exercises exclusive authority over.[32] Once an emergency is declared, the Stafford Act allows the President to direct federal agencies to utilize resources in support of any State or local efforts, coordinate disaster relief assistance, provide technical and advisory assistance, provide emergency assistance through federal agencies, and assist in the distribution of food and other supplies.[33] The Act also allows the President to provide accelerated Federal assistance where necessary to save lives, prevent human suffering, or mitigate severe damage.[34]
The Stafford Act allows federal resources to be used in coordination with the State or jurisdiction’s response efforts.[35] In this way, it provides a safety net for states that may not have the resources to handle large scale disasters.
- Federal Food, Drug and Cosmetic Act
The Federal Food, Drug and Cosmetic Act is the enabling statute for the Food and Drug Administration (FDA).[36] During public health emergencies, the Act allows the FDA to authorize the sale of products that are not yet approved, licensed, or cleared for commercial distribution.[37] During a pandemic, this provision would allow for tests, vaccines, and other helpful medications to be quickly available to the public without having to go through the burdensome process of becoming FDA certified.
The FDA already exercised its emergency powers in reaction to COVID-19. The FDA implemented a policy to allow certain laboratories to develop and use COVID-19 before the FDA has completed its review of the Emergency Use Authorization requests.[38] This policy was aimed at quickly expanding the United States’ testing capabilities and displays the flexibility of the FFDCA during times of emergency.
- Conclusion
While the idea of a deadly disease quickly spreading around our communities is a harrowing thought, rest assured that the Federal Government is well equipped to fight it. And if you happen to get quarantined, don’t panic, enjoy the alone time, and know that the federal government will keep you fed. Oh, and please remember to wash your hands.
[1] Alina Bradford, Penicillin: Discovery, Benefits and Resistance, Live Science (May 30, 2019), https://www.livescience.com/65598-penicillin.html.
[2] Id.
[3] Stephanie Pappas, How do Vaccines Work?, Live Science (June 1, 2010), https://www.livescience.com/32617-how-do-vaccines-work.html.
[4] Catharine Paddock, Taking Antibiotics for Viral Infections Can Do More Harm Than Good, CDC, Medical News Today (Nov. 20, 2011), https://www.medicalnewstoday.com/articles/237975#1.
[5] Naveed Saleh, Brief Guide to Antiviral Drugs, Verywell Health, https://www.verywellhealth.com/brief-guide-to-antiviral-drugs-1124123 (last updated Oct. 28, 2019).
[6] Berkeley Lovelace, The Slow Race to Make a Coronavirus Vaccine is on as Nations Try to Speed Yearlong Process, CNBC (Jan. 31, 2020, 2:31 PM), https://www.cnbc.com/2020/01/31/coronavirus-why-it-takes-at-least-a-year-to-make-a-vaccine.html.
[7] Jennifer Calfas & Jim Carlton, Coronavirus Spreads in California, New York as U.S. Death Toll Rises to 11, Wall St. J., https://www.wsj.com/articles/coronavirus-spreads-in-washington-state-as-amazon-worker-tests-positive-11583318127 (last updated Mar. 4, 2020).
[8] Julia Hollingsworth et al., February 29 Coronavirus News, CNN, https://www.cnn.com/asia/live-news/coronavirus-outbreak-02-29-20-intl-hnk/index.html (last updated Feb. 29, 2020).
[9] Calfas & Carlton, supra note 7.
[10] Hollingsworth et al., supra note 8.
[11] Nancy Messonnier, Director, CDC Nat’l Ctr. for Immunization, CDC Telebriefing Update on COVID-19 (Feb. 26, 2020).
[12] Id.
[13] Lesson 1: Introduction to Epidemiology, CDC, https://www.cdc.gov/csels/dsepd/ss1978/lesson1/section11.html (last visited Mar. 2, 2020).
[14] Debora MacKenzie, Covid-19: Why won’t the WHO Officially Declare a Coronavirus Pandemic?, New Scientist (Feb. 26, 2020), https://www.newscientist.com/article/2235342-covid-19-why-wont-the-who-officially-declare-a-coronavirus-pandemic/.
[15] Coronavirus Disease 2019 (COVID-19) Situation Summary, CDC, https://www.cdc.gov/coronavirus/2019-ncov/summary.html (last updated Feb. 29, 2020).
[16] 42 U.S.C. § 247d(a) (2006).
[17] Id.
[18] Id.
[19] Id. § 247d(b)(1).
[20] Id. § 247d(b)(2)(A).
[21] Id. § 247d(b)(2)(A)–(F).
[22] 42 U.S.C. § 300hh-11(a) (2006).
[23] Id. § 300hh-11(a)(2)(A)–(B).
[24] Id. § 300hh-11(a)(3)(A)(i).
[25] 42 U.S.C. § 300hh-2 (2018).
[26] Id. § 300hh-2(b)–(c).
[27] 42 U.S.C. § 264(a) (2018).
[28] Legal Authorities for Isolation and Quarantine, CDC, https://www.cdc.gov/quarantine/aboutlawsregulationsquarantineisolation.html (last visited Mar. 2, 2020).
[29] 42 C.F.R. § 70.6(a) (2019).
[30] Id. § 70.6(b).
[31] 42 U.S.C. § 5191(a) (2018).
[32] Id. § 5191(b).
[33] 42 U.S.C § 5192(a)(1)–(7).
[34] Id. § 5192(a)(8).
[35] Id.§ 5192.
[36] 21 U.S.C. § 360bbb-3(a)(2) (2018).
[37] Id.
[38] Press Release, FDA, Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics (Feb. 29, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-new-policy-help-expedite-availability-diagnostics.
