The Food and Drug Administration has a message for the personal genomics revolution: slow down. Personal DNA tests have been available for years now from companies like 23andMe and Pathway Genomics, and the direct-to-consumer tests have sold briskly even while the companies tried to sort out whether or how their systems would be regulated by the FDA. Then last month, Pathway took the next big step, offering to sell their tests over the counter in the nation's largest drugstore chain, Walgreens. For the FDA, that was one step too far, and it began to make noise about regulation. Now the agency's leader in this field, Alberto Gutierrez, has sent official letters to all the major personal DNA-testing companies saying it intends to regulate the tests as medical devices, and that the companies must provide evidence of their scientific validity.
The letters, posted on the F.D.A. Web site on Friday, say the companies must apply for approval or discuss with the agency why certain test claims do not require such approval. But the letters stop short of saying the tests must be taken off the market until they are approved. Dr. Gutierrez said in an interview that it would be unfair to remove the tests from the market because the agency had not clearly told the companies that the devices needed approval [The New York Times].
Should your access to your own genome really be controlled by the FDA? As we noted when we covered the reasons why it might be a bad idea
for Walgreens to carry the tests, it's the consequences of that information that have the regulators concerned. The personal genomics companies don't just send you a report with a bunch of A's, C's, G's and T's: They interpret the data, and sometimes give risk assessments for disease. Gutierrez says the companies must account for that.
Gutierrez said in an interview that if a person can do nothing about a genetic risk discovered through a test, "that at least should be stated somewhere." He added that companies are also responsible for anticipating possible harm from a test -- such as a person adjusting their drug doses on the basis of a result -- and should take steps to "mitigate that risk" [Washington Post].
Just how those companies will "mitigate that risk" enough to satisfy the FDA remains unclear. But the risk of people using information that hasn't been seen by doctors to self-medicate was enough for the FDA to reverse its previous position. Genome.gov
, the site of the National Institutes of Health's National Human Genome Research Institute, states:
The Food and Drug Administration (FDA) regulates tests sold as "diagnostic devices," that is, tests manufactured by one company and then sold as a kit to a laboratory for genetic testing. However, the FDA does not regulate "home brew" tests, that is, tests that are both manufactured and performed by the same laboratory. Many common genetic tests (including the BRCA breast cancer gene tests) fall into this category. Because of this regulatory exception, genetic testing services using home brew tests can be marketed directly to the medical community -- and the public -- without FDA regulation or oversight.
Not anymore. These tests qualify for that "home brew" definition, The New York Times says
, but the FDA has clearly chosen to jump into the regulation ring. The companies' statements sound like they intend to comply. But this new regulatory process could slow the race to get more and more genetic testing into the hands of consumers. Walgreens first said that Pathway Genomics had reassured them the tests it was going to sell didn't require FDA approval, but then decided to put its plans on hold
after the FDA complained and Congress said it might investigate. And 23andMe, one of the highest-profile companies in the group, didn't do itself any favors this month when it goofed and gave up to 96 customers the wrong genetics reports
. Related Content: 80beats: 5 Reasons Walgreens Selling Personal DNA Tests Might Be a Bad Idea
Image: flickr / nosha