The Food and Drug Administration announced on November 17 that it gave emergency use authorization (EUA) for the first at‐home diagnostic test for COVID-19. The Lucira COVID-19 All‐in‐One test kit is designed to be self‐administered. People can collect their own sample using a nasal swab, swirl the swab in a vial, and get the test result in 30 minutes.
The FDA requires people to get a prescription from a health care practitioner in order to buy and use the test. Children under 14 are required to have the test performed by a health care practitioner. Patients who present to doctors’ offices, urgent care centers, clinics, or hospitals may still self‐administer the test once it is prescribed, but if the patient is 14 or under the practitioner must perform the test.
This is a welcome development. The ability to perform the test at home and get quick results should provide great assistance in identifying and isolating infected and contagious people, and help bring the spread of the virus under better control. But, why should this require a prescription?
At home pregnancy tests are self‐administered, are about 99 percent accurate—as effective as a urine pregnancy test taken in the doctor’s office—and can be purchased over‐the‐counter in most pharmacies without a prescription.
The Ora‐Quick In‐Home HIV Test Kit was approved by the FDA to self‐administer in 2012. The kit provides the result on an oral sample in 20–40 minutes. It is available in stores and online without a prescription for anyone over age 17.
As Michael F. Cannon and I discuss in “Drug Reformation: Ending Government’s Power to Require Prescriptions,” prior to the passage of the 1951 Durham‐Humphrey Amendment to the Food, Drug, and Cosmetic Act of 1938, it was up to the manufacturer to decide whether to require a prescription. The manufacturer’s decision was governed by liability concerns as well as concerns about its reputation.
Placing that power in the hands of the FDA disrespects patient autonomy and the right to self‐medicate. It increases the cost of obtaining medications by requiring visits to doctors’ offices and pharmacies and may contribute to higher drug prices. As we explain in our paper, it also makes patients less safe.
Additionally, it brings politics into the prescription vs over‐the‐counter decision‐making process. That’s why it took twelve years and a court order before the emergency contraceptive Plan B became available OTC without age restrictions. It also has something to do with why oral contraceptives require a prescription in the U.S. while they are over‐the‐counter in more than 100 countries.
Forcing people to get a prescription for the at‐home COVID test burdens them with the expense in time and money of going to a doctor’s office to get the prescription when they don’t even need the doctor to perform the test. It also subjects them to the risk of contracting COVID, if they don’t already have it, from other patients in the waiting room or lobby. In short, it erases many advantages of an at‐home test.
The FDA did good when it gave the COVID-19 at‐home test an EUA. It would be even better—and less paternalistic—if it let people buy the test kit without a prescription.