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23andMe is Back on the Market — Finally

This article was originally published on November 5, 2015 in the San Francisco Chronicle.

Last week, 23andMe announced that it will once again provide direct-to-consumer genetic tests, nearly two years after the FDA ordered its original product off the market. Many are celebrating the return as a “triumph” and an illustration of how innovation, coupled with a capable CEO like Anne Wojcicki, can overcome regulatory hurdles.

Unfortunately, the product 23andMe now markets is a far cry from what it once offered. Instead of receiving interpretations of their own susceptibility to various diseases, consumers get results about their carrier status for genetic diseases. While helpful, this is a much less substantial service. As The New York Times explains, it provides results “of most interest to people planning to have babies . . . and there are separate carrier tests available through doctors from other laboratories.”

Meanwhile, the fact remains: when the FDA first ordered 23andMe to stop marketing its full Personal Genome Service (PGS), it exercised poor judgment and deprived consumers of agency over their health.

Through its PGS, 23andMe offered customers information about their ancestry and health, including genetic predisposition toward having, developing, or carrying a number of diseases.
But just before Thanksgiving 2013, the FDA demanded that the company stop marketing its PGS, insisting that it was subject to the agency’s “premarket approval” and “marketing authorization.”

This wait harms consumers who would otherwise have information about their potential health risks—and the ability to act on that information. As long as the PGS is stuck in FDA approval purgatory, new customers cannot access their personal health information and seek medical guidance about potential health risks. They have less knowledge, and control, of their own health.

The FDA’s rationale also demonstrated a flawed understanding of its own mandate. It feared that consumers with false positive test results “for breast or ovarian cancer” would “undergo a prophylactic surgery, chemoprevention, intensive screen, or other morbidity-inducing actions.” This concern assumes that, before undergoing such major treatment, consumers would not first want—and have—to be screened by a physician.

But a 2013 study controverts the agency’s fears, finding that all surveyed women who used direct-to-consumer genetic tests, and who were identified as having a mutation associated with an increased risk of breast or ovarian cancer, consulted a doctor after receiving the results. Those who opted for surgery consulted multiple doctors.

The FDA also expressed concern that consumers would forgo further testing if they receive a “false negative” for these types of mutation. Here again, the FDA assumed the worst about consumers. The agency’s role is not to limit choice because it thinks consumers cannot make good choices for themselves, but to ensure that the products themselves are safe.

The objective of FDA medical device approval is to determine whether the benefits provided by the device outweigh its potential risks. PGS data should undergo the rigor of scientific review, so long as there is compelling evidence that it may be harmful. The benefits of PGS are numerous yet, the risks remain unsubstantiated.

Wojcicki says she’s optimistic that the FDA will eventually approve 23andMe’s more ambitious PGS product. When that day does finally arrive, it will be great news for those who want greater agency over their health.

It’s a shame the FDA’s paternalism has delayed the moment for so long.

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