On Nov. 22, the Food and Drug Administration flexed its regulatory muscles by sending a warning letter to a genetic-testing company that goes under the stylish name of 23andme.
The company was selling to the general public a $99 saliva-based test that could give customers information about some 240 genetic traits, which relate to a wide range of disease conditions. The FDA wants to evaluate 23andme’s product as a Type III device under the Medical Devices Act. These devices require premarket approval before they can be sold to the public.
Unlike Regenerative Sciences, LLC v. United States, where the FDA improperly claims that certain stem-cell procedures for joint disease amount to drug use requiring FDA approval, the FDA appears to be on solid legal ground here. The current definition of “medical devices” covers devices both used for the treatment and diagnosis of disease in the human body. But if legally sound, the FDA’s position is socially dubious: Getting premarket approval for hundreds of separate tests is arduous business, with prohibitive costs and enormous delay.
The FDA’s warning letter lists the dangers that could follow from allowing 23andme’s kits to be sold to the public, but it gives no balanced assessment of the benefits of such sales. For instance, the warning letter observes that a “false positive” on 23andme’s test “could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening or other morbidity-inducing action.” Fair enough. But the inverse is also correct: A true positive could lead a patient to undergo much-needed prophylactic surgery, chemoprevention, intensive screening or other morbidity-reducing actions.
The gist of the FDA’s position is that putting more information in the hands of the consumer leads to bad outcomes because it could result in overconfident actions by patients who have the temerity to treat themselves without physician assistance. But the FDA, and indeed anyone else, can always remind people that it is best to seek medical treatment for dangerous conditions because self-medication is a risky business — as if that fact were not known far and wide already.
In assessing a test like 23andme’s, the FDA should determine the relative proportions of good and bad outcomes from the test. There is no reason whatsoever for it to stop with its list of hypothetical bad outcomes, without inquiring into their frequency and severity. Some information on the efficacy of these kits is of course available in this case, given that they have been marketed for more than five years to about 475,000 customers.
The FDA should first collect some hard data on how those patients fared over that time. In dealing with these scenarios, however, the FDA always wants to put the burden of proof on companies to show that their products are safe and effective. It will never look at field results that the companies present that tend to support that result. The public would be better served, however, if the FDA collected clear and convincing survey evidence that the widespread use 23andme’s test generated the dangerous results that the FDA hypothesizes.
FDA overreach has heavy costs. When the FDA keeps a product off the market, downstream actions by individual consumers and their physicians cannot undo its mistakes. But if the product is let on the market, patients and physicians need not use it if its risks outweigh its benefits. Let the FDA and experts warn away, so long as they do not ban products, which given standard patterns of usage may do far more good than harm. It is time that Congress recognized that much of the danger to patient comes from the FDA. Its vaunted mission is “Protecting and Promoting Your Health.” I for one wish it would quit trying to protect mine and that of other people who would like to control their own lives.Richard Epstein is the Laurence A. Tisch Professor of Law at NYU Law School and a visiting scholar with the Manhattan Institute, which published a longer form of this column as well as a longer paper by Professor Epstein on the pending Regenerative Sciences litigation.