Leading the Way in Life Science Technologies

GEN Exclusives

More »


More »
August 01, 2010 (Vol. 30, No. 14)

Justifying Regulation of DTC Tests

Good Policies Are in the Best Interests of Direct-to-Consumer Companies and Consumers

  • Click Image To Enlarge +
    Chris MacDonald, Ph.D.

    The Food and Drug Administration recently signaled, in no uncertain terms, its intention to regulate the provision of direct-to-consumer (DTC) genetic testing. As reported by a number of news outlets, the FDA sent letters (dated June 10) to Knome, 23andMe, deCode, Illumina, and Navigenics stating that the agency regards the tests those companies market as medical devices, and hence they require premarket approval.

    The response by the companies involved is varied. Some have indicated an intention to resist the FDA’s move to regulate them. Others have welcomed it. Pundits and scholars have disagreed among themselves, too. Some have argued that this move oversteps the FDA’s proper authority. Others have disagreed, citing the FDA’s overall mandate to protect consumers.

    It’s tempting to think of DTC genetic tests as being in a class of their own, as far as ethics and regulation go. In their complexity, genetic tests are much like (heavily regulated) pharmaceuticals. But as a source of “mere information,” a genetic test is more like a (loosely regulated) home-pregnancy test.

    Then again, given the possibility that test results could be the basis for life-changing decisions, genetic test might be analogized to (totally unregulated) self-help books. Add to these various dimensions the fact that genetic tests are new, unfamiliar, and rapidly evolving, and it’s easy to start thinking of DTC tests as being in a league of their own. But when it comes to regulation, the problems really are quite general, and so we can shed light on the question of regulating DTC genetic tests by thinking about the ethical rationale for regulation.

  • Justification for Markets

    But if we really want to understand the “big picture,” the full ethical context within which to situate the question of regulating DTC genetic tests, it’s worth considering the way in which the ethical justification of regulation is rooted in the ethical justification of market behavior more generally.

    We generally think that people ought to be free to buy and sell according to their own needs, interests, and preferences. This implies a freedom to conduct exchanges in a relatively self-centered (or profit-seeking) way. But it’s worth considering what the ethical underpinning is for that freedom.

    The ethical underpinning lies in the idea that free exchange on the market is mutually beneficial, and that a relatively free market is good for society, as a whole, in the long run. But it’s widely recognized that, whatever the properties of ideal markets, real markets are far from perfect, and in order to be beneficial for all concerned, they sometimes need to be nudged or even bridled by regulation.

    We often see the least need to impose regulatory restrictions when trade goes on among equals, on a roughly level playing field. So, for example, when two companies, both with a sophisticated technical understanding of the product being bought and sold, do business, there seems to be relatively little need for regulation. Regulatory agencies (and courts for that matter) have little to do but act as a kind of referee.

    But in the world of retail—selling things directly to a large number of very imperfectly informed consumers—the situation is somewhat different.

Related content