When in November 2020 the Food and Drug Administration (FDA) proudly announced that it had approved the first at-home self-administered test for COVID-19, there was one catch: patients must get a prescription from a licensed health care practitioner (who is instructed to prescribe it only to symptomatic patients) to purchase and self-administer the test. This not only defeats the purpose of an at-home test but runs counter to the goal of restraining contagion.
This is not the first time the FDA has obstructed individuals from obtaining information about their health status. In the early 1970s, the FDA temporarily halted at-home self-administered pregnancy tests. The FDA restricted at-home HIV tests, developed in the late 1980s, well into the early 21st century. Currently, the FDA strictly curtails the development of at-home genetic testing, useful in screening for hereditary diseases. In every instance, regulators paternalistically cited concerns that patients may use the obtained information unwisely.
Does this regulatory conduct exceed authority granted by the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1938? Should regulatory authority be more clearly restricted to the safety and accuracy of at-home tests? Most important, is the FDA violating the fundamental right of autonomous adults to obtain information about their health status? Two experts on law and medical ethics will reply to these and other questions.