 In the United States, medications and tests utilized to asses medical conditions may only be introduced into the stream of commerce once they pass numerous, stringent requirements. However, when a public health emergency surfaces that could be managed effectively with products and therapies not yet approved, provisions in the law permit the FDA to fast track biologics, diagnostic tools and other medical equipment.
On February 4, 2020, the Secretary of the Department of Health and Human Services (HHS) determined that COVID-19 posed a public heath emergency to U.S. citizens. By declaring this public health emergency, the Secretary of HHS triggered section 564(b)(1)(C) of the Federal Food, Drug and Cosmetic Act. In accordance with this provision, the FDA Commissioner may allow unapproved medical products, or unapproved uses of approved medical products, to be used to test for or to treat the life-threatening disease causing the health crisis. For each item approved to assess, treat or protect against COVID-19 during this time period, an Emergency Use Authorization (EUA) is issued. To date, the following EUAs have been issued: MEDICATIONS March 28, 2020
DIAGNOSTICS February 4, 2020
In the above list, 27 products have been approved to provide a qualitative assessment of COVID-19 in the upper and/or lower airway. Three of those products can be performed at the location where the patient is being tested. One additional product has been approved to test for antibodies in whole blood, serum or plasma. Normally, it takes months or years to have a new test approved or to have a medication approved for off-label use. Under this circumstance, the speed with which these tests was developed is truly remarkable. Also, national testing will certainly be accomplished more rapidly as a result of the FDA’s issuance of these EUAs. If you know someone who is exhibiting signs, tell that person to do a search for testing locations in or around their communities. As the number of companies approved to manufacture tests increases, the number of available tests will increase, and commensurately, the number of testing sites will increase. Early detection can help manage the virus. QUESTIONS YOU MAY HAVE
Below is a link to the FDA website listing all EUAs issued to date in response to COVID-19: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov
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