Is FDA's Crackdown on Direct-To-Consumer Genetic Testing a Violation of the First Amendment?

In November 2013, the U.S. Food and Drug Administration (FDA) ordered the company 23andMe to stop offering its direct-to-consumer DNA testing service, which provided individuals with $99 assessments of their genetic risk for almost 200 disorders. Experts now examines whether this move by FDA is a violation of the First Amendment, or a necessary step to protect consumers.

23andMe seemingly made it easy for individuals to decode their own genome without having to go through a physician. Using a kit the company provided, an interested individual mailed in a saliva sample that got analyzed by 23andMe for a broad spectrum of genes and mutations. Many initially hailed this Personal Genome Service (PGS), as 23andMe called it, as a medical revolution. It gave people direct access to critical information about their health risks while allowing them to contribute to a genetic database that could serve as a valuable resource for medical researchers. When the company failed to provide FDA with evidence of the PGS test’s validity, though, the agency shut down the operation in order to protect consumers from receiving invalid test results that could lead people to seek unnecessary — or not seek necessary — medical treatment.

“Direct-to-consumer companies should have a sense of responsibility to provide tests that are only clinically valid and can be used in ways to provide information about diagnosis, treatment, management, or prevention of a disorder,” said Baudhuin. “Including a large group of incomplete and/or meaningless tests with unvalidated risk calculations confuses the consumer, demeans the overall test, and contributes to wasted healthcare time and money.”

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