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Novel coronavirus testing moves ahead under special section of U.S. federal code

U.S. federal actions come as authorities work to swiftly respond to emergencies
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In 2009, the Food and Drug Administration made available a means to approve new drugs, devices, or indications for use during a time of emergency. FDA is collaborating with public and private enterprises to speed the American response to novel coronavirus. FDA’s regulatory vehicle to do this is called emergency use authorization (EUA).

EUA authority stems from Section 564 of the United States Federal Food, Drug, and Cosmetic Act (FFDCA) and permits the Food and Drug Administration (FDA) to use unapproved medical products—everything from devices to drugs—to diagnose, treat, or prevent serious diseases or conditions.

EUAs have become increasingly common in the past decade as the agency moves to respond quickly to fast-spreading viruses and other public health emergencies. On February 4, 2020, the Department of Health and Human Services issued one to combat the new coronavirus (SARS-CoV-2). On February 29, 2020, the FDA issued guidance which went into effect immediately for diagnostic lab testing of the virus.

The February 29th announcement authorized use of real-time reverse transcriptase polymerase chain reaction (RT-PCR) diagnostic panels developed by the Wadsworth Center at the New York State Department of Public Health; oligonucleotide probes and primers made by Integrated DNA Technologies (IDT) are included.

The announcement also means more labs can apply to conduct testing of SARS-CoV-2, explains Time. Before it, only two CDC labs and a few state ones could test for COVID-19. Expanding the testing network was key, as the nation’s low infection rate could simply have been due to the challenges associated with testing.

While the EUA directed at SARS-CoV-2 is hogging the limelight, it’s just one of several EUAs currently in effect. Other active EUAs cover:

  • Anthrax
  • Ebola
  • Freeze dried plasma (to support American military personnel)
  • Enterovirus D68
  • H7N9 Influenza
  • Middle East Respiratory Syndrome (MERS)
  • Nerve agents
  • Zika virus

The go-ahead issued by the FDA on February 29, 2020, was for the “presumptive qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal/oropharyngeal swabs and sputa collected from individuals who meet CDC COVID-19 clinical and/or epidemiological criteria (for example, clinical signs and symptoms associated with COVID-19, contact with a probable or confirmed COVID-19 case, history of travel to a geographic locations where COVID-19 cases were detected, or other epidemiologic links for which COVID-19 testing may be indicated as part of a public health investigation) pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act.”

An allied EUA was also issued on February 29, 2020, for personal protective equipment (PPE).

The February 29th EUA was issued just 48 hours before the head of the FDA promised that 1 million coronavirus tests would be available within days. The oligonucleotide probes and primers that go into those tests, as The New York Times noted, are being produced by IDT and sent to academic, health care, public health, and commercial labs around the country.

“The process of getting a test kit out and putting it into production is not something that happens literally overnight, in particular when you’re talking about a million tests,” Eric Blank, the chief program officer at the Association of Public Health Laboratories, told The New York Times.

EUA components include:

  • FDA approval: needed
  • Institutional review board approval: not needed
  • Informed consent: as required by the FDA
  • Specific protocol trainings: none
  • Adverse event monitoring: to the extent practicable given the circumstances of the emergency
  • Recordkeeping and access: to the extent practicable given the circumstances of the emergency
  • Duration of approval: for the duration of the EUA declaration under which it was issued

On a side note, EAUs are not the same as INDs and IDEs. INDs, or Investigational New Drug exemptions, are for the use of unapproved drugs or biologics. IDEs, or Investigational Device Exemptions, are for the use of unapproved medical devices.

In a press conference on March 2, Timothy Stenzel, the director of the Office of In Vitro Diagnostics and Radiological Health at the FDA, noted that labs could also choose to purchase IDT oligonucleotide probes and primers. Labs with a lot of oligonucleotide probes and primers can verify the test as they normally would any lab developed test in the lab prior to use, and then move on to clinical testing without the need of applying for their own EUA.

The FDA backed up the EUA with fact sheets for both healthcare providers and patients. The fact sheet for patients notes that the test (which they may have just been given) “is not yet approved or cleared by the United States FDA” but that it was included under the EUA umbrella.

For the most up-to-date information on the outbreak, visit the Centers for Disease Control and Prevention website.