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Point of View : Aug 1, 2010 (Vol. 30, No. 14)

Justifying Regulation of DTC Tests

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

Goals of Consumer Regulation

So what are the goals of consumer regulation? The simplest reason behind some kinds of regulations is to increase efficiency by standardizing things like weights and measures and various technical protocols that make it easier for business to be conducted. Here, government plays a simple yet important coordinative function. But, perhaps, the most obvious reason for regulations in at least some domains is consumer protection.

Some regulations seek to protect consumers by means of outright prohibitions, such as the prohibition on retail sales of heroin. Other regulations protect consumers by requiring businesses to provide prospective customers with information. Among information-based protection regulations, we can further distinguish two forms: regulations that require making sure consumers are informed of dangers (e.g., the dangers of cigarettes) and regulations that require giving consumers the information to makes sure that products meet their particular needs (e.g., the need for particular nutritional characteristics in foods).

Sometimes, of course, regulations lack good justification. Regulations are made by humans and are hence subject to the full range of human flaws. But it’s important to see—and differentiate among—the various ethical justifications that make sense of various regulations in the first place.

"It's Only Information"

Finally, a word about regulating information-based services. Some have expressed shock at the idea that government might want to regulate a service like genetic testing, a service that, after all, merely provides information. Of course, the idea that test results are “merely information” is far from reassuring.

Information can obviously be dangerous in many ways. This is not to say that the kind of information produced by a whole-genome scan is particularly dangerous; it’s just a reminder that information-based services are not inherently risk-free.

In part, the worry here is related to the difference between data and information. After all, the reason that the results of tests by a company like Navigenics or 23andMe are worth paying for is that those companies don’t just give customers a series of C’s, G’s, A’s and T’s. They also provide some level of interpretation. And such interpretation is an inherently normative process—a process of deciding how to interpret the data, and which information, at which level of complexity, ought to be delivered to the paying customer. There really is nothing “mere” about information in a context like this.

Another perspective from which to criticize regulation of DTC genetic tests points out that such regulations erect barriers to individuals gaining information that is, after all, about them. How can government deny me information about myself? But it’s critical to see that denying a company the unfettered right to sell something is importantly different from denying consumers the right to buy it. It’s also important to see that sometimes we put regulations in place not to because every consumer needs protection but because some do. Not all such regulations are justifiable; but surely at least some are, and the debate needs to be conducted in recognition of that fact.

Conclusion

None of this implies that companies wishing to sell genetic testing services directly to consumers ought to be whole-hearted fans of maximal government regulation. There’s room for honest disagreement about the usefulness of various tests and about the possibility that consumers will be harmed or even just misled by them. But it’s pretty widely understood that having good, clear regulations can, in fact, be in the interests of business.

Clear regulations, after all, provide a stable environment in which to invest and may well provide a measure of safety from ad hoc administrative rebuke (by agencies like the FDA or the Federal Trade Commission) or even from plaintiffs’ attorneys. But my larger point here is that companies in the DTC genetic testing field need to formulate their responses to the question of regulation in a way that demonstrates a sensitivity to the legitimate goals of regulation. For the goals of regulation are, at heart, the goals of the free market itself: to foster exchanges of goods and services that truly do end up making life better for us all.