Regulation Expert Weighs In on FDA Letter to 23andMe

“Regulation Expert Weighs In on FDA Letter to 23andMe.” Mendelspod.com.

On Monday, November 25th, the FDA sent a letter to the direct-to-consumer genetic testing company, 23andMe. The letter has received a bit more attention than the average FDA correspondence. The letter was addressed to 23andMe CEO, Anne Wojcicki, and told her that the company’s Personal Genome Service was in violation of the Federal Food, Drug and Cosmetic Act. The FDA requested that the company “immediately discontinue marketing” the test until it receives authorization.

Since the letter came out, there has been much discussion in the life science industry and with the public at large. Some say the letter reveals an over reaching, paternalistic government agency trying to hold back the inevitable, while others see the opportunity for a turning point for a diagnostics industry.

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