FDA lightens up on ‘outrageous’ direct-to-consumer genetic information ban

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Food and Drug Administration (FDA) head Scott Gottlieb is reeling in his agency’s outrageous four-year ban on direct-to-consumer genetic testing.

Under the Obama administration, the FDA sent a letter to the genetic testing company 23andMe warning that the company was “marketing the 23andMe Saliva Collection Kit and Personal Genome Service…without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act.”

The folks at 23andMe had little choice but to knuckle under to the agency’s demands and stop testing new customers.

In April of this year, the FDA finally allowed the company to supply customers with genetic health risk information for 10 different conditions, including late-onset Alzheimer’s disease, Parkinson’s disease, celiac disease, and hereditary thrombophilia (harmful blood clots). Before the ban, the company had been providing its users with some genetic insights with regard to all of those health risks and about 140 others.

Gottlieb’s statement dramatically loosens his bureaucracy’s stranglehold on direct-to-consumer genetic testing. After genetic health risk test manufacturers have passed through a one-time FDA review ensuring that they meet the agency’s requirements for accuracy, reliability, and clinical relevance, any subsequent additional health risk tests will not need to undergo further review.

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post: The FDA Will Finally Let You See Your Genetic Information