FDA to Issue Emergency Use Authorization for Monkeypox Tests

Even as the COVID-19 public health emergency (PHE) nears its inevitable conclusion, it appears that the FDA will remain active on the Emergency Use Authorization (EUA) front. In a move to expand access to lab testing for monkeypox, the U.S. Department of Health and Human Services (HHS) has authorized the FDA to issue EUAs for in vitro diagnostic tests for the virus.   

The FDA’s EUA Powers

FDA approval of new lab tests is a lengthy process that’s ill-suited for public health emergencies involving new and previously unknown diseases requiring rapid government response. That’s why the Federal Food, Drug, and Cosmetic Act includes a provision, section 564, giving the HHS Secretary authority to allow the FDA to authorize use of unapproved medical products or unapproved uses of medical products during a PHE.

What used to be a relatively obscure provision resorted to only on rare occasions, section 564 became and remains a crucial element in the federal government’s response to the COVID-19 PHE, enabling hundreds of new lab tests for detecting the SARS-CoV-2 virus that causes coronavirus to reach the market.

Lab Tests & Monkeypox Response

As with COVID-19, the federal government has made expansion of access to testing a priority in its monkeypox response strategy. Like SARS-CoV-2, the monkeypox virus responsible for the current outbreak was an unknown virus for which no lab tests were currently available. In June, HHS partnered with five major diagnostics companies—Quest Diagnostics, Labcorp, Mayo Clinic Laboratories, Aegis Sciences, and Sonic Healthcare—for rapid development of new tests for monkeypox for national distribution via the US Centers for Disease Control and Prevention (CDC) public health Laboratory Response Network (LRN). However, access challenges remain.

Having declared a PHE for monkeypox on Aug. 4, HHS ramped up its response effort by once more giving the FDA the green light to clear monkeypox tests on an EUA basis. Under section 564, FDA may provide EUA clearance to a monkeypox test product if it determines that, among other things:

• The product may be effective in diagnosing, treating, or preventing the emergency disease or condition;
• The known and potential benefits of the product outweigh its known and potential risks; and
• There’s currently no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition.

HHS Secretary Xavier Becerra described the action as “an important step forward in our monkeypox response” designed to speed up “development of more validated monkeypox tests and expand access to testing.”

The move comes as no surprise. As of Sept. 7, when the announcement was made, there were 21,274 cases confirmed in the US and 56,026 cases globally, according to the CDC. HHS reports that current testing capacity in the US has increased to more than 80,000 tests per week with about 86 percent testing capacity available.

The Monkeypox EUA Strategy

On the same day that HHS announced that it was allowing EUA clearance for monkeypox tests, the FDA issued guidance outlining how it intends to exercise its new authority. First priority for EUA review will go to submissions from “experienced developers with high manufacturing capacity” for high-throughput tests where samples can be collected at home, and rapid antigen tests.

The FDA also says it doesn’t plan to enforce certain federal regulatory requirements for laboratory developed tests for monkeypox used by labs and used without EUA, provided that tests are “appropriately validated” and that the labs notify the FDA of their use within 30 days of making the product available.  

The monkeypox policy is surprisingly similar to the market-now-and-get-permission-later approach the agency took in allowing serology antibody and other non-molecular COVID-19 tests to reach the market without first completing FDA review. With the agency’s guard down, dozens of junk antibody tests were able to penetrate the US market. The FDA quickly corrected what it would later acknowledge was a flawed policy, cracking down on the dubious tests, tightening review and product standards, and promising not to repeat the mistake when responding to future PHEs. 

But the FDA’s tactics are a little different this time. The agency says it won’t object to use of monkeypox antibody tests developed and performed by CLIA-certified labs operating under academic medical centers, as long as test results are used alongside other diagnostics for direct medical care of the patient. 

“This should mitigate the potential misuse of monkeypox serology test results while also fostering research from availability of data from serology testing of patients,” according to the FDA.