Testing Freedom

In the latest Discourse Magazine I discuss the FDA’s long-standing fear and antipathy toward personalized medical tests and how this violates the 1st Amendment.

In 1972, the FDA confiscated thousands of home pregnancy tests, declaring that they were “drugs” meant to diagnose a “disease” and thus fell under the FDA’s regulatory dominion. The case went to the U.S. District Court for the District of New Jersey, and Judge Vincent P. Biunno ruled that the FDA had overstepped. “Pregnancy,” he said, “is a normal physiological function of all mammals and cannot be considered a disease … a test for pregnancy, then, is not a test for the diagnosis of disease. It is no more than a test for news….” As a result of Judge Biunno’s ruling, home pregnancy tests are easily available today from pharmacies, grocery stores and online shops without a prescription.

These days, debates over home pregnancy tests from the 1970s seem anachronistic and paternalistic. Yet the same paternalistic arguments appear again and again with every new testing technology. In the late 1980s, for example, the FDA simply declared that it would not approve at-home HIV tests, regardless of their safety or efficacy. As with pregnancy tests, the concern was that people could not be trusted with information about their own bodies…the first rapid at-home HIV test was developed and submitted to the FDA in 1987 [but] it took 25 years before the FDA would approve these tests. (Now, you can easily buy such a test on Amazon.)

…The FDA has a vital role in ensuring that tests are clinically accurate—tests should do what they say they do. Tests don’t need to be perfectly accurate to be useful (think of thermometers, personality tests and tire pressure gauges), but if a test advertises that it measures HDL cholesterol, it should do that within the tolerances the firm promises. The FDA has the technical knowledge to ensure that tests work, and that’s a skill that Americans value from the agency.

What Americans don’t want is to be told they can’t handle the truth. Yet when it came to at-home tests such as pregnancy tests, HIV tests and genetic tests, that’s exactly the reasoning the FDA used—and continues to use—to suppress information. The FDA should ensure that tests are safe, but “safety” means physical safety. The FDA may not declare a product unsafe because it might produce dangerous knowledge. Patients have a right to know about their own bodies. Our antibodies, ourselves. The FDA has authority over drugs and devices but not over patients.

Judge Biunno had it right back in 1972 when he said that diagnostic tests produce “news.” Test results, therefore, are a type of speech that fall under the First Amendment right to freedom of speech. The Supreme Court has repeatedly rejected restrictions on freedom of speech based on “a fear that people would make bad decisions if given truthful information”; thus, FDA restrictions on tests based on such fears are unconstitutional. The question of whether consumers will respond “safely” to test results is no more relevant to the FDA’s regulatory authority than the question of whether readers will respond safely to political news published in The New York Times. The FDA does not have the constitutional authority to regulate news.