On Feb. 1 the White House announced it was buying 8.4 million Ellume at‐home, self‐administered diagnostic tests it hopes to get to consumers across the country starting later this month. The at‐home test is cheap and rapid and will enable people who have no COVID symptoms but are nonetheless infected and contagious, to test themselves for the disease. It has been a great challenge to stop the virus from being spread unwittingly by people who are asymptomatic carriers, who may make up 30 percent or more of people infected with the virus. This test should therefore be a great help in getting the pandemic under control. The Ellume at‐home test received Emergency Use Authorization from the Food and Drug Administration in mid‐December 2020.
At‐home self‐administered tests have actually been available at least since last November, when the FDA granted Emergency Use Authorization to the Lucira at‐home self‐administered test. But incomprehensibly the FDA requires people to get a prescription from a health care practitioner in order to purchase the test to self‐administer at home. And providers are instructed to give a prescription only to patients who are symptomatic. These requirements, of course, cancel out any advantages an at‐home test provides controlling the pandemic.
As we discussed last week at a Cato online policy forum, the FDA has a history of restricting the public from at‐home tests that directly provide them with information about their health status—ranging from at‐home pregnancy tests to at‐home HIV tests to at‐home salivary diagnostic genetic tests. The FDA is paternalistically concerned that autonomous adults may improperly apply the information they learn about themselves—an overly‐broad interpretation of its responsibility to assure the “safety” and “efficacy” of newly developed tests.
It is good that we will finally get to see at‐home tests make their way to the general public. It is a shame that the public needlessly waited so long.
Commentary by Jeffrey A. Singer. Originally published at Cato At Liberty. https://www.cato.org/blog/home-self-administered-covid-tests-without-prescription-may-finally-be-available-it-didnt-have