Article

FDA Must Enable More Testing To Contain Monkeypox Spread

Law360
July 27, 2022

Initially published in Law360

Since the U.S. confirmed its first monkeypox case on May 18, there are now 3,591 reported cases.[1] So far, the number of reported cases closely mirrors those numbers reported during the early months of the COVID-19 pandemic. Globally, there are now over 19,000 monkeypox cases, with deaths reported in Africa.

Now, over two months after the first reported case in the U.S., the World Health Organization declared that the monkeypox outbreak constitutes a global health emergency.[2]

While the number of reported cases seems relatively small at this time, accurately tracking the number of reported cases correlates to the ability to test and diagnose monkeypox, and the response to test suspected cases of monkeypox has been abysmal. Diagnostic testing for monkeypox is critical to stop the spread of the virus. Yet, in the first six weeks of the outbreak, all U.S. laboratories combined ran a total of just 2,000 orthopoxvirus tests.[3]

A month after the first confirmed monkeypox case, the U.S. Department of Health and Human Services, through the Centers for Disease Control and Prevention, began shipping orthopoxvirus tests to five commercial laboratories. These labs are just coming online, with Mayo Clinic Laboratories and Quest Diagnostics Inc. beginning to test for monkeypox on July 11 and July 13, respectively.

Now, U.S. laboratories collectively can process roughly 60,000 orthopoxvirus tests per week. With increased testing we may get a more accurate picture of how many individuals are impacted and where it is spreading fastest, and most importantly, where to dedicate resources to suppress transmission and disease spread.

However, a limited capacity to run the orthopoxvirus tests — and a limited case definition for who can actually receive it — explains those images on television of longs lines and frustrated individuals who just cannot get the care that others receive, such as access to the orthopoxvirus vaccine or U.S. Food and Drug Administration-approved medications such as Tecovirimat.[4]

In the end, the current reported amount of monkeypox cases does not reflect the true scope of this outbreak as testing is only beginning to ramp up.[5] This is problematic, as the Centers for Disease Control and Prevention will only report confirmed cases in its online database. Other public health officials are losing faith that we have control of this disease, indicating that testing capacity is coming online when we have likely already lost control of the spread of monkeypox.

According to National Institute of Allergy and Infectious Diseases Director Anthony Fauci, "We don't know the scope and the potential of it yet, but we have to act like it will have the capability of spreading much more widely than it's spreading right now."[6]

Taking it one step further, former FDA Commissioner Scott Gottlieb did not hold back with his stark warning by saying we are already in a pandemic — and warned that we have failed to contain the spread of monkeypox.

In an interview with Face the Nation, Gottlieb stated, "I think the window for getting control of this and containing it probably has closed. If it hasn't closed, it's certainly starting to close."[7]

There are many parallels to the conversations around testing availability for monkeypox when compared to those conversations had at the beginning of the COVID-19 pandemic. Just as with monkeypox, lack of testing during the early stages of COVID-19 allowed the number of infected individuals to grow quickly while the number of reported cases remained relatively small for months.

To put it in perspective, there were 15 confirmed cases of COVID-19 on Feb. 15, 2020. One month later, there were roughly 4,000 reported COVID-19 cases.[8] Two weeks after that — at the end of March 2020 — there were roughly 184,000 reported COVID-19 cases.[9]

Why the exponential growth in the number of reported COVID-19 cases? Testing availability. By the end of April 2020, the FDA authorized roughly 100 test and sample collection devices for emergency use. It is impressive to think that three months prior — at the beginning of the COVID-19 pandemic — not one test existed, considering the disease is caused by a novel virus.

In comparison, there is a test that exists for monkeypox at this time, but it is not easy to perform. Further, from a public health perspective, the test does not help much as it relates to suppressing transmission.

The CDC's FDA-cleared nonvariola orthopoxvirus test can detect monkeypox via lesion sample. Lesion sampling involved performing a test for monkeypox by swabbing the blisters or pimples that appear on the body.

However, by the time an individual shows blisters or pimples — ranging from a few to a few thousand — they may have already had the disease for up to three weeks. An individual is most contagious when showing blisters or pimples, and this stage lasts for an additional two to four weeks.

In the end, contracting monkeypox can be a seven-week-long ordeal. While COVID-19 now has a death rate of roughly 1.7%, the monkeypox strain impacting the U.S. has a death rate of around 3%, with its sister variant in Africa having a death rate of around 10%.[10]

Six days before the U.S. confirmed its first case of monkeypox, the U.S. Government Accountability Office issued its report on the steps FDA took to make testing available during the COVID-19 pandemic.[11]

The report is a reminder of the swift action the FDA took during the early stages of the COVID-19 pandemic to ensure testing availability in a shorter period of time through its emergency use authorization authority. The FDA's actions allowed for numerous unauthorized tests — that otherwise would have had to go through the FDA's premarket review — to be made available to detect the virus that causes COVID-19.

The GAO report is an important reminder on testing availability and accessibility in the early stages of disease spread. By the end of December 2021, there were almost 400 tests for COVID-19, with more coming out.

Unfortunately, such swift action has not been replicated in these early stages of the monkeypox outbreak. The GAO's report recommended that the FDA "develop a policy for the use of enforcement discretion regarding unauthorized tests in future public health emergencies."[12]

Who could imagine that just a little over two years later, we would now be facing another global health emergency? However, no policy exists from the FDA yet. Unrealistically, the FDA would have had to develop the policy just two months after the GAO's report and recommendation.

A lack of testing availability may be one of the reasons that we are facing another health emergency. Now that the World Health Organization declared a public health emergency, the FDA must act as swiftly as possible to contain this terrible disease.


Ryan Michael Fournier is a partner at Wiley Rein LLP.

The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

[1] As of July 27.

[2] See N. Grover, J. Revill, and J. Rigby, WHO Declares Global Health Emergency Over Monkeypox Outbreak, July 23, 2022, available at https://www.reuters.com/business/healthcare-pharmaceuticals/monkeypox-outbreak-constitutes-global-health-emergency-who-2022-07-23/.

[3] See https://www.npr.org/2022/07/09/1110667122/there-has-been-a-shortage-of-testing-and-vaccines-for-monkeypox.

[4] FDA approved Tecovirimat for the treatment of smallpox on July 13, 2018. There are roughly two million doses stockpiled in the U.S. Strategic National Stockpile and has been shown to be extremely effective against the treatment of Monkeypox. However, only a select few of individuals actually receive Tpoxx given it is estimated to take roughly 3-5 hours of paperwork to obtain for one patient.

[5] See N. Thomas, NYC Monkeypox Numbers are 'Definitively' Not the Full Picture, Health Official Says, July 19, 2022, available at https://www.cnn.com/2022/07/19/health/nyc-health-commissioner-monkeypox/.

[6] C. Hassan, A. Elamroussi, As Fauci Warns Monkeypox Needs to be Taken More Seriously, Former FDA Commissioner Says the Window to Control it 'Probably has Closed,' CNN Health, July 17, 2022, available at https://www.cnn.com/2022/07/17/health/monkeypox-cases-undercounted-fauci/index.html.

[7] Interview with Dr. Scott Gottlieb, Transcript: Dr. Scott Gottlieb on 'Face the Nation', July 17, 2022, available at https://www.cbsnews.com/news/scott-gottlieb-transcript-face-the-nation-07-17-2022/.

[8] See www.worldometers.info/coronavirus/country/us.

[9] Id.

[10] https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/vaccine-standardization/smallpox.

[11] U.S. Government Accountability Office, COVID-19 – FDA Took Steps to Help Make Tests Available; Policy for Future Public Health Emergencies Needed, May 2022, available at https://www.gao.gov/products/gao-22-104266.

[12] Id.

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