Experts Side with FDA Over 23andMe

You may have heard by now that the Food and Drug Administration (FDA) has ordered 23andMe to halt the marketing of its health-related direct-to-consumer DNA test kits. (It is still allowed to sell its DNA test kit for genealogy purposes). Many saw this as a controversial decision.

The FDA had concerns about the potential health risks that a consumer could face after receiving inaccurate results from the DNA test that 23andMe offers. The test kits do not require people to speak with a doctor about the results. This could lead people to make inaccurate choices about their health care. Therefore, the FDA required 23andMe to discontinue selling its Personal Genome Service (specifically, the health related information about a person’s DNA) until such time as it receives FDA marketing authorization.

On the other hand, there are people who disagreed with the decision that the FDA made. Some genealogists worried that the decision made by the FDA could slow down their genealogy research. Others (including patients’ right advocates) felt that the FDA had neither the expertise nor the right to make the decision it made.

Now, two experts have stated their opinions about the controversy. Each say that the FDA has done the correct course of action. That is the view of Boston University bioethicist George Annas and Northwestern University’s Dr. Sherman Elias, who is a professor of obstetrics and clinical genetics.

They wrote “The FDA was right to issue a warning to 23andMe”. They note that the field of consumer genomics is new and rapidly changing. This could easily result in health information that is incorrect, incomplete, or unexplained. The experts point out that the FDA is insisting that the health related genetic services that are offered by companies like 23andMe be reliable, accurate, and promised to work as intended. “That is traditional consumer protection, and what the public expects from the FDA” the two experts wrote.

On the other side of the issue, 23andMe founder Anne Wojcicki argues that genetics could be used for preventative medicine. and to bring down the cost of health care. She said that the FDA’s decision “slowed up the number of people signing up” with 23andMe.

Even so, 23andMe has 650,000 people in their database and that they have more data on genetics than anyone else in the world. People who had purchased a direct-to-consumer DNA kit from 23andMe could choose to allow their genetic information to be shared with others. This could, potentially, result in finding a cure for a fatal disease.

Image by Sergio Calleja on Flickr.

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