FDA Streamlines Review Process for Direct-to-Consumer Genetic Testing

Published December 3, 2017

The U.S. Food & Drug Administration (FDA) is developing a more efficient process for obtaining government approval for direct-to-consumer genetic testing for health risks.

In 2015, FDA demanded 23andMe stop selling the Personal Genome Service Genetic Health Risk test, a procedure testing consumers’ genetic samples for predispositions to genetic health risks (GHRs), because the company had not received government permission, known as pre-market review, to do so.

On November 6, 2017, FDA Commissioner Scott Gottlieb, M.D., issued a statement reversing the agency’s policy and announcing a new, faster review process for consumer GHR services.

GHR test manufacturers will be exempted from the normal FDA pre-market review procedure for each individual new product or test. Instead, GHR manufacturers will undergo a one-time review, similar to how FDA certifies the accuracy and reliability of digital health technologies.

Regulations Stifling Innovation

Devon Herrick, a policy advisor to The Heartland Institute, which publishes Budget & Tax News, says FDA has a history of inhibiting consumer product innovation.

“The FDA under the Obama administration never wanted to allow access to direct genetic testing,” Herrick said. “Like other medical regulators, FDA has a natural bias to control access to medicine.”

FDA bureaucrats assumed consumers were incapable of properly judging information, Herrick said.

“In the past, the FDA assumed individuals were not in a position to understand the results of genetic testing,” Herrick said. “There are numerous pathways that affect genetic expression. No one genetic test can positively predict breast cancer, Alzheimer’s, or other conditions, and the FDA wanted a doctor to explain those facts to everyone who had a genetic test.”

Bio-Data Bottleneck

Many direct-to-consumer medical tests were once prohibited by government regulators, Herrick says.

“Years ago, the FDA refused to allow over-the-counter tests for AIDS, because the agency wanted all those with a positive test result to have counseling along with the test results,” Herrick said. “For that matter, even home pregnancy tests were somewhat controversial when they first arrived.”

The new policy is a win for consumers interested in taking more responsibility for their own health, Herrick says.

“This is a great development,” Herrick said. “Gottlieb wants to empower consumers to make more of their own medical decisions.”

Kept the Gates Closed

Jeff Stier, a senior fellow with the National Center for Public Policy Research, says the old policy enshrined doctors as the gatekeepers of medical data.

“The reason the previous FDA didn’t allow this is that they wanted everyone to go through a doctor to get basic information about themselves,” Stier said.

Power to the People

The new FDA policy will enable better medical decision-making, Stier says.

“It’s a freedom-oriented move, without sacrificing needed regulations,” Stier said. “It will still be regulated, but they can choose to get genetic counseling, which may be a good idea, but you won’t have to go to a doctor to get consent.

“Say the patient is predisposed to Alzheimer’s,” Stier said. “We think we know that staying active reduces the risk, and knowing that you’re predisposed could make an impact on your decision of how to change your behavior.”