On August 4, 2022, Health and Human Services (HHS) Secretary Xavier Becerra declared monkeypox a national public health emergency (PHE). Already, the World Health Organization, several U.S. states (California, Illinois, New York) and major cities (e.g., New York, Los Angeles, Dallas, San Francisco) had declared their own emergencies. Now that Becerra has declared a national emergency more state and cities will likely follow.
Just two days earlier, President Biden appointed Robert Fenton Jr., a regional administrator with the Federal Emergency Management Agency (FEMA), as the White House’s new monkeypox coordinator. Fenton is an experienced leader in managing emergencies including logistics and supply chains. Demetre Daskalakis, director of the Division of HIV/AIDS Prevention at the Centers for Disease Control and Prevention (CDC), was also appointed as the deputy coordinator. His long-standing work at CDC is deeply trusted by LGBTQIA+ communities.
These two actions – the PHE and Monkeypox coordinators – signal a turning point in the U.S. monkeypox response after a lackluster start in the first 100 days.
With over 8,900 reported cases across nearly every state, and tens of thousands more globally, declaring monkeypox a national emergency means the U.S. is now battling 2 national emergencies simultaneously—COVID-19 and monkeypox. Monkeypox does not present the same level of risk to the U.S. population as COVID-19, the worst infectious disease pandemic since the Great Influenza Pandemic of 1918. But monkeypox requires urgent action before it spills over into the wider population.
Monkeypox symptoms can be painful and cause suffering, but thus far there have been no known domestic deaths. The monkeypox virus is not transmitted by airborne particles like SARS-CoV-2. Monkeypox spreads primarily by close skin-to-skin physical contact, but also can be spread via contaminated surfaces. While the virus has been detected in semen and blood, its direct sexual transmissibility is unconfirmed. The vast majority of reported cases are among men who have sex with men (MSM), although anyone can contract monkeypox through close contact. Cases among women and children have been reported. Unlike during the meteoric rise of COVID-19 in early 2020, effective vaccines and treatments are already available for monkeypox.
So why the need for a national PHE? Despite every lesson learned from COVID-19 on the critical need for core funding, timely surveillance, ample supplies, and delivery of vaccines and treatments, U.S. public health and health care systems cannot seem to get ahead of the monkeypox outbreak. Federal, state and local public health agencies are stretched thin due to chronic underfunding and diversion of resources to the COVID-19 pandemic. Dedicated funding for frontline state and local monkeypox responses is scant. Public health surveillance is sketchy. Testing and vaccines are in short supply. Access to available treatments is insufficient. Consequently, cases have exploded nationally over the last several weeks.
The problem lies not so much with a lack of preventive options to control monkeypox, but the failure to fully and effectively use them. HHS’ PHE declaration is designed to trigger enhanced national response efforts to contain monkeypox. Pursuant to legal authorities under the Public Health Services Act (PHSA), HHS can launch a series of critical responses to improve interjurisdictional funding and coordination, enhance surveillance, secure and allocate vaccines, and help assure greater access to testing and treatment.
National Coordination. Monkeypox is a textbook case for a PHE. Secretary Becerra declared the emergency pursuant to PHSA § 319, which authorizes a PHE for 90 days (subject to renewals), to address “significant outbreaks of infectious diseases or bioterrorist attacks.” Upon a declaration, the Secretary can “take such action as may be appropriate” to respond to the PHE, including initiating grants, contracts, and investigations into its “cause, treatment, or prevention.” HHS can also tap the Public Health Emergency Fund for critical support efforts, although remarkably funds are not currently allocated for this purpose.
The national PHE declaration signals to public and private sectors the seriousness of the emerging threat to health. National, state, and local declarations collectively mobilize opportunities for interjurisdictional coordination at the national level. Concerted, real-time actions supported by federal resources and timely communications based on epidemiological trends can help contain the spread of monkeypox before it spreads exponentially in MSM communities and the wider population, including college students heading back to campuses soon.
Public health surveillance. Effective communication strategies rely on accurate data. Extensive, timely, and widespread data sharing accord with proven public health surveillance practices particularly with infectious diseases like monkeypox (that are not primarily airborne). The U.S. public health system, however, currently lacks sufficiently strong surveillance to back up key interventions.
Since the “New Federalism” era in the early 1990s, the Supreme Court has limited the federal government from forcing states or their localities to comply with federal dictates. Federal agencies cannot command states to comply with national surveillance efforts, but it can incentivize them through spending and contracting supported by national emergency powers.
HHS is reporting that over 50 state and local jurisdictions have executed data use agreements to share monkeypox surveillance and vaccine administration information with CDC. The Centers for Medicare & Medicaid Services (CMS) is collecting its own data on available testing and hospitalization rates related to monkeypox. Other federal agencies like Veterans Affairs may survey its health information as well. These efforts will help immensely in profiling the spread of monkeypox through additional innovative data acquisition and surveillance sharing practices.
Testing Capacities. Reported monkeypox cases in the U.S. are undercounted due to sporadic testing and reporting. Persons may be infected for up to 3 weeks prior to experiencing early signs (e.g., fever, headache, muscle aches, respiratory symptoms, fatigue, rash). CDC’s initial reliance on its Laboratory Response Network (LRN), a collection of 67 federal labs in 48 states capable of processing more than 8,000 monkeypox tests per week, proved insufficient. On June 22, HHS authorized 5 private laboratories to perform testing as well, boosting the nation’s weekly testing capacity nearly 10-fold. Still, cases are undetected and undercounted, necessitating in part the PHE declaration.
Vaccine allocation and distribution. One of the graces of the current outbreak of monkeypox was the foresight to develop, produce and store FDA-approved Jynneos vaccines through coordinated public-private sector efforts. Yet multiple missteps contribute to supply shortages and administration of vaccines to at-risk Americans. Less than a decade ago, the U.S. had had 20 million Jynneos vaccine doses in the Strategic National Stockpile (SNS), but by May 2022 most doses had expired. Production of the two-dose vaccine produced by Denmark’s Bavarian Nordic awaits proper packaging to facilitate its use.
HHS’ emergency authorities can accelerate vaccine allocation and distribution. The Department reports sending over 600,000 doses of vaccine to states and localities, with hundreds of thousands of additional doses in route in the weeks ahead. Scaling up production is key. The White House has announced advanced contracts and other efforts to secure significant new supplies of vaccine.
Additionally, Commissioner Robert Califf announced on August 9 that FDA has approved an emergency use authorization (EUA) for “dose-sparing approaches” that will yield additional vaccine protections for tens of thousands of additional at risk persons (age 18 and older) using existing vaccine supplies. EUA determinations allow unapproved medical products or unapproved uses of approved medical products to be used more extensively in an emergency.
Treatment. FDA has designated tecovirimat (a.k.a. TPOXX) used to treat monkeypox as an “investigational drug,” essentially requiring a series of convoluted bureaucratic steps to acquire it. A national PHE can help expedite its distribution. Already, FDA application forms for doctors seeking access to the drug for their patients have been simplified. Pursuant to the Food, Drug, and Cosmetic Act § 564, HHS’ Secretary may also declare that an EUA for drugs like TPOXX is appropriate.
Innovative applications pursuant to separate federal declarations under the federal Public Readiness and Emergency Preparedness Act (PREP) Act could enhance access as well, although no declaration has been issued to date. PREP Act declarations by HHS’ Secretary would facilitate rapid advancement of medical countermeasures needed to “diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic; or to limit the harm such pandemic or epidemic might otherwise cause.” PREP Act declarations often include extensive allowances for use, authorize licensure reciprocity across states, and provide significant liability protections for persons involved in the chain of medical countermeasure distribution and administration.
Access. Even if drugs or vaccines can be secured through the SNS, patients are experiencing significant access limitations at swamped health care clinics in hard-hit urban areas due to health care worker shortages. HHS’ PHE authorizes deployment of federally-trained or organized medical personnel or teams. Coupled with a PREP Act declaration, other licensed health care workers across the nation can uniformly provide enhanced testing, treatment or vaccination efforts. During the COVID-19 pandemic, for example, HHS relied on PREP Act declarations to authorize pharmacists to directly administer vaccines notwithstanding conflicting state-based licensing limitations.
Additional emergency powers. HHS’ PHE declaration may later be coupled with a Presidential emergency declaration via the Stafford Act or National Emergencies Act to provide even greater legal options – including select waivers of conflicting federal and state laws, access to greater emergency response funds, direct federal interventions, and temporary state-based deviations from Medicaid requirements.
President Biden can mandate more extensive efforts to meet demand by invoking the Defense Production Act, essentially requiring private industry to produce more vaccine for limited periods. Though repeatedly relied on during the COVID-19 pandemic to generate rapid supplies of ventilators, syringes, and other medical countermeasures, the President has not fully signaled his use of the Act regarding the monkeypox outbreak to date.
Respect, dignity and inclusivity. Respect for patient privacy and dignity is vital. The HIV/AIDS pandemic revealed how a public health strategy that stigmatizes or discriminates against MSM communities is counterproductive. Policy formation and implementation must be accomplished through inclusive participation with affected communities. Comparisons of monkeypox infections to the start of the HIV/AIDS pandemic in the early 1980s are inevitable. In both cases, we have seen delayed federal responses and the potential for stigmatization among those at greatest risk. Historic and current discrimination experienced among LGBTQIA+ populations tied to disease transmission warrants strong attention to health privacy, supportive messaging, and anti-discrimination practices as surveillance and response efforts ramp up dramatically.
Designating the monkeypox outbreak as a national PHE offers considerably upgraded emergency authorities and flexibilities to coordinate responses across federal, state, and local agencies and providers. Wielding these powers effectively and fairly is key to ameliorating rising cases and resulting morbidity before the spread of monkeypox impacts greater numbers of Americans.
James G. Hodge, Jr., JD, LLM, is the Peter Kiewit Foundation Professor of Law and Director, Center for Public Health Law and Policy, at the Sandra Day O’Connor College of Law, Arizona State University, Phoenix, AZ.
Lawrence O. Gostin, JD, is the University Professor and Founding O’Neill Chair in Global Health Law at Georgetown University Law Center, Washington, DC. He directs the WHO Collaborating Center on National and Global Health Law.