By James G. Hodge, Jr., J.D., LL.M. and Lawrence O. Gostin, J.D.
Monkeypox is America’s newest emergency — and not a moment too soon. On August 4, 2022, Health and Human Services (HHS) Secretary Xavier Becerra declared monkeypox a national public health emergency(PHE). His declaration was proceeded by the global designation via the World Health Organization on July 23, and emergency pronouncements by multiple states (California, Illinois, New York) and cities (New York, Los Angeles, San Francisco) the week prior.
Designating monkeypox a national PHE is a turning point in U.S. response efforts following moribund early efforts over the first 100 days of the outbreak. Now, with over 7,500 reported cases across the U.S., and thousands more globally, the case for declaring a PHE is clear.
Unlike COVID-19, monkeypox infection is not usually fatal, but its symptoms can be painful and disabling. Persons may be infected for up to 3 weeks prior to experiencing early signs (e.g., fever, headache, muscle aches, respiratory symptoms, fatigue, rash). While COVID-19 spreads primarily via airborne routes, monkeypox is acquired typically via close physical/sexual contact or through contaminated surfaces. Most reported cases of monkeypox to date are among men who have sex with men (MSM), although select cases among women and children have also arisen. Absent considerable public health interventions, considerably greater numbers of U.S. cases are projected to follow.
Justifying a national PHE. As seen repeatedly during the COVID-19 pandemic, U.S. public health authorities and health care providers are struggling to come to terms with escalating cases of monkeypox. Grossly-underfunded and overwhelmed public health agencies are not able to conduct proper surveillance and face vast shortages of testing services, vaccines, and treatment. HHS’ 90 day, renewable PHE declaration under the Public Health Services Act (PHSA) can jump start essential public health interventions through interjurisdictional coordination, enhanced surveillance, vaccine distributions, real-time testing, and emerging treatments. Access to federal public health emergency funds are also available, although they are largely depleted.
HHS’ PHE declaration was coupled with President Biden’s appointments last week of Robert Fenton Jr. with the Federal Emergency Management Agency, and Demetre Daskalakis at the Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention (CDC), to coordinate monkeypox response efforts. If the President (with his advisors) later determine that monkeypox constitutes a national emergency under the Stafford Act or National Emergencies Act additional legal options surface – including waivers of select federal and state laws, more direct federal interventions, and temporary state-based deviations from Medicaid requirements. President Biden could also invoke the Defense Production Act to require private industry to produce medical countermeasures for limited periods.
Focus on communications. At the heart of public health interventions to stymie infectious disease spread are effective public health communications framed on accurate epidemiological data. For weeks, however, monkeypox surveillance activities have been spotty and inconsistent. A national PHE can help remedy these issues through federal incentives to encourage sharing of available health data among state and local public health agencies.
Over 50 state and local jurisdictions have entered data use agreements to share monkeypox surveillance and vaccine administration information directly with CDC. To enhance monkeypox testing capacity and generate more accurate results CDC upgraded its Laboratory Response Network in June to authorize testing among 5 private labs as well, ramping up weekly yields by nearly 10-fold.
Other federal entities like the Centers for Medicare & Medicaid Services and Veterans Affairs are mining their own data on available testing and hospitalization rates related to monkeypox. These enhanced surveillance efforts and other innovative data sharing practices significantly enhance real-time data at the core of public health communications.
Vaccine allocations. Unlike with COVID-19, where vaccines had to be conceptualized and developed under extreme stresses, the Food and Drug Administration (FDA) previously approved Jynneos vaccines as safe and effective in the prevention of monkeypox. So why are so many Americans unable to access vaccines? It comes down to supply and demand. Millions of doses of Jynneos vaccines in the national Strategic National Stockpile (SNS) expired earlier this year, and new production by Denmark’s Bavarian Nordic has been slowed as global requests rise.
HHS’ emergency interventions are at work already to alleviate this crisis. Recently, HHS has acquired and has sent over 600,000 doses of vaccine directly to states and localities. Hundreds of thousands of additional doses are in route. FDA Commissioner Robert Califf announced that the Administration may soon authorize “dose-sparing approaches” that can expand available vaccine supplies up to 5 times by altering injection methods.
Accessing treatment. Persons experiencing symptoms of monkeypox can be effectively treated with known pharmaceuticals, but accessing them, like vaccines, has proven monumental. To date FDA has designated the leading drug, TPOXX as “investigational,” meaning it is not easily available in the U.S. (despite other countries’ allowing ready access). Pursuant to emergency authorities allowed via the Food, Drug, and Cosmetic Act § 564, HHS’ Secretary may initiate an emergency use authorization (EUA) through FDA for TPOXX to facilitate its wider distributions to physicians and patients.
A distinct federal declaration under the Public Readiness and Emergency Preparedness Act (PREP) Act could improve access to treatments and vaccines as well. PREP Act declarations by HHS’ Secretary would facilitate rapid advancement of medical countermeasures by broadening their scope of use, providing significant liability protections, and authorizing interstate licensure reciprocity so health care workers can provide enhanced testing, treatment or vaccination efforts nationally (as pharmacists and others have done during the COVID-19 pandemic). Surprisingly a PREP Act declaration has not been issued to date.
Respect for patients. Decades ago the HIV/AIDS pandemic revealed damaging public health strategies can be if they stigmatize or discriminate against MSM communities. Latent responses to monkeypox at the federal and state levels have drawn comparisons between monkeypox and HIV/AIDS. Historic and modern discrimination of LGBTQIA+ populations tied to disease transmission justifies substantial health privacy protections, supportive messaging, and commitments to anti-discrimination practices and approaches designed to assure persons at risk of monkeypox gain access to medical countermeasures without experiencing discrimination in health care, workplace, or other environments.
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.
