Journal of Free Speech Law: "Freedom of the Test," by Prof. Alex Tabarrok

Here is an excerpt; the full article is here:

At-home testing—DNA testing, for example—is one of those personalized medicine advances that would have been unthinkable not too long ago. DNA tests can tell us about our ancestry, which diseases we may be especially prone to, and which drugs might work especially well or poorly for our body.

Personalized medicine can adjust medications not only to DNA which is unchanging but also to the dynamic response of RNA, proteins, and metabolites. Chen et al. describe how a patient was treated via a “personal omics profile (iPOP), an analysis that combines genomic, transcriptomic, proteomic, metabolomic, and autoantibody profiles from a single individual over a 14-month period.” Studies like this point to a future in which we will be able to measure a disease or an infection and a body’s response across many different variables in close to real-time. A personal omics profile could thus optimize healthcare strategies not just to a particular person but to a particular person at a particular time and place.

And we do have a history of making use of some aspects of personalized medicine in the United States. While the most advanced tests and devices are not yet integrated with the medical mainstream, pregnancy tests and AIDS tests have been common for years. The recent COVID pandemic also illustrated the value of real-time, at-home tests for viral antigens. Popular wearables like Fitbit are relatively simple medical devices that provide real-time measurements for things such as blood oxygen levels, skin temperature, and heart rate. Much more will be possible as sensors become cheaper, more refined, and more integrated with our bodies….

Personalized medicine, however, has advanced at a far slower rate than the underlying data and technology. U.S. Food and Drug Administration (FDA) regulation has slowed adoption and increased costs for tests and devices that inform patients about their own bodies. In fact, the FDA has a long-standing fear and antipathy towards personalized medical tests.

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 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 today easily available from pharmacies, grocery stores, and online shops without a prescription….

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