Last chance to give the FDA your views on consumer genetic testing services

Some time ago I complained about Maryland restrictions on direct-to-consumer genetic testing. The FDA is currently deliberating about whether to impose similar restrictions for the entire U.S., essentially forcing anyone wanting access to their own genetic data to do so only through their doctor.

If you’re at all interested in this particular issue, or if you’re concerned about government restrictions on personal freedom in general, I urge you to submit a public comment before the deadline of midnight tonight (Monday, May 2). (Note that the page has a timeout feature, so if your comment is more than a sentence or two I advise you to compose and save it beforehand and then paste it into the comments field. Also, for really long comments you can upload a Word or PDF document.)

You can find some good background information in a post at the Genetic Future blog, including some links to other people’s comments. However as a layman here’s what I think are the key points:

First, we’re not talking here about potentially toxic drugs or about potentially dangerous medical tests (e.g., X-rays, CAT scans, etc.) where there’s a truly valid concern about consumer safety. There’s no direct risk of harm from genetic testing, so opponents have to fall back on hypothetical scenarios about people suffering psychological harm or otherwise doing bad things based on the results of testing. To the extent that such scenarios are likely (and that’s the subject of much dispute) that’s an argument for companies providing more context for results and appropriate cautions, not an argument for prohibiting people entirely from having access to their own genetic data unless it’s through their physician.

Second, people already have access to lots of information that’s relevant to their personal health. For example, people can find out a lot from their own family history, e.g., whether their parents, grandparents, siblings, etc., have had higher-than-normal incidence of heart disease, breast cancer, mental illness, rare diseases of various sorts, and so on. They can also take their own temperature, get a blood pressure reading at their local supermarket, and even do home testing for cholesterol. They can then go online and research the implications of this and other information on health information web sites maintained by government agencies, hospitals like Johns Hopkins and the Mayo Clinic, and commercial ventures like WebMD and Healthline. I don’t believe that genetic tests as currently offered direct to consumers are so qualitatively different that they justify a significantly more stringent regulatory framework.

Finally, some level of regulation is arguably appropriate. It’s entirely reasonable that government adopt regulations to ensure that genetic tests are done in an accurate manner, that standard data formats are used to allow people to transfer their genetic data between services, that health-related information provided in association with tests be written or reviewed by physicians and qualified geneticists, and that false advertising and unethical practices be prohibited.

The bottom line is that it doesn’t make sense to adopt heavy-handed regulations in advance of any real evidence that it’s required. It’s bad for consumers looking for information relevant to their personal health, and bad for the emerging personal genomics industry, which might otherwise become a significant driver of economic growth and health care cost reductions. If you agree, head on over to the comments page and tell the FDA what you think.