Defending Our Right to Test: How the FDA Restricts Direct‐to‐Consumer At‐Home Testing
Featuring Nita A. Farahany, JD, PhD (@NitaFarahany), Robinson O. Everett Professor of Law, Professor of Philosophy, Duke Law School; Jessica Flanigan, PhD (@missjessica), Associate Professor of Leadership Studies and Philosophy, Politics, Economics, and Law, Richard L. Morrill Chair in Ethics and Democratic Values, University of Richmond; moderated by Jeffrey A. Singer, MD (@dr4liberty), Senior Fellow, Cato Institute.
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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.
Additional Resources
- “Don’t Try This at Home: The FDA’s Restrictive Regulation of Home‐Testing Devices,” by Shelby Baird
- “Respect Patients’ Choices to Self‐Medicate,” by Jessica Flanigan
- “A Prescription Is Not Required for an At‐Home Pregnancy Test or an At‐Home HIV Test—Why Require One for an At‐Home COVID Test?,” by Jeffrey A. Singer
- “Drug Reformation: End Government’s Power to Require Prescriptions,” by Jeffrey A. Singer and Michael F. Cannon
- “Regulation: The FDA Is Overcautious on Consumer Genomics.” by Robert C. Green and Nita A. Farahany
