Skip to main content
Premium Trial:

Request an Annual Quote

FDA Cracks Down on DTC Genetic Testing

The blogosphere is buzzing with the news that the FDA is finally cracking down on direct-to-consumer genetic tests, treating them as if they were medical devices and informing companies that sell them that they are selling medical devices without FDA approval. The New York Times' Andrew Pollack says the FDA has sent letters to five companies last week, saying they must have regulatory approval before selling the DTC tests. "Premarket review allows for an independent and unbiased assessment of a diagnostic test's ability to generate test results that can reliably be used to support good health care decisions," wrote the FDA's Alberto Gutierrez in the letters, as quoted by Pollack. The letters stop short, however, of telling the companies to pull the tests off the market, Pollack adds.

Gutierrez told Newsweek's Mary Carmichael that the reason the FDA is only just beginning to crack down on the tests is that the claims of the companies have been very vague and constantly changing, making it hard for the regulatory body to determine how they were being used. But recent findings have shown that the tests could be considered medical devices, Gutierrez says. "If you’re making a claim about [a genetic variant that affects the metabolism of the anticoagulant drug] warfarin, and somebody decides based on the result they get that they want to change their dosing, that is a fairly risky decision. That could affect their health," he told Carmichael.

Pharmacogenomics Reporter, one of the Daily Scan's sister publications, reported that these letters are what the FDA calls "untitled" letters, meaning the companies have been made aware of the FDA's concerns and have a chance to address them and make whatever changes the FDA deems necessary. Based on their responses, the FDA could upgrade to "warning" letters, which are more severe. PGx Reporter's Turna Ray also reported that several presenters at the Consumer Genetics Conference in Boston in the beginning of June said they thought federal regulation of DTC tests was "imminent."

Genomics Law Report's Dan Vorhaus says the letters may not be as significant to the five companies involved — 23andMe, Navigenics, Decode Genetics, Knome, and Illumina — as everyone thinks, especially since the FDA hasn't demanded that the companies remove the products from the market pending review. "So, at least for the moment, we may see little or no immediate change while these companies weigh their options internally and through discussions with the FDA," Vorhaus writes. He suggests the companies' best option would be to change the tests in such a way that would convince the FDA they no longer qualify as medical devices - "for instance by removing the ability of consumers to purchase the product without the participation of a healthcare provider."

Daniel MacArthur at Genetic Future thinks this turn of events could spell disaster for the personal genomics industry. "Excessive regulation would negatively impact on innovation in the field by increasing the barrier to entry for new products, as well as increasing costs for consumers," he says, adding that this move looks like it's motivated by publicity on the FDA's part — in the wake of the 23andMe test results mix-up — rather than by a genuine drive to protect consumers.

John Timmer at Ars Technica agrees that this development could put a freeze on further companies entering the DTC genetics market, and "significantly alter" the price of existing DTC genetics tests, but has a different opinion on what motivated the FDA to get serious about regulation. "It's pretty obvious that the DTC companies were promoting the ability of their services to offer information relevant to human health to one degree or another. … The FDA's action is as much about recognizing that reality as anything else," he says.