Decoding FDA DTC Policy: Part 4 – The Physician/Genetic Counselor Perspective

by | Nov 15, 2018 | FDA User Experience Study, Genetic Testing

Finding this post on or after Friday, November 16, 2018? This exploration of the affect on genetic counselors is part of a 5-part series on FDA DTC policy, which you can now find in its entirety as one post here. Feel free to read on, however, if you prefer to read it in daily chunks.



Scott D. Crawford, M.A., Shawn Fayer, M.Sc., M.S., C.G.C., Robert C. Green, MD, MPH

Note:  See Part 1 for further details about these authors.

The National Society of Genetic Counselors’ position statement on DTC testing from 2015 states that consumers have the right to make an informed decision on DTC genetic testing. As with other DTC tests based on SNP array technology, it is important that companies offering these tests are very clear when discussing their limitations. For instance, the 23andMe Personal Genome Service Pharmacogenetic Reports (PGSPR) panel is limited to those SNPs that are detectable by their array and is by no means an exhaustive list of all possible PGSPR variants within the genes investigated on this panel. It should also be noted that there are many PGSPR genes that are not being evaluated on this panel.

That said, the information consumers learn from this test could prove meaningful to their future health. For this reason, genetic counselors urge anyone who is considering this test to talk with their doctor or a genetic counselor either before or after purchasing a kit. Since PGx is still an emerging area of clinical genetics, many clinicians may not yet be comfortable discussing these results. Thus, it is ideal to start the discussion before testing and a genetic counselor is specially trained for such discussions.  Independent networks of fully licensed genetic counselors and physicians who are experts in genetics like Genome Medical are now available in all 50 states.

There are groups outside of the FDA who are working hard to inform the public about genetic links to health risks as well as pharmacogenetics. The Clinical Pharmacogenetics Implementation Consortium (CPIC) publishes a list of guidelines.

Return tomorrow for the final part in this series – “Decoding FDA DTC Policy: Part 5 – Final Thoughts

The contents of this post are not intended as, nor should be considered legal, regulatory, health, or any other form of advice for any specific situations – they simply represent the opinions of these authors.

About the Author

Scott D. Crawford

Scott D. Crawford is the Founder and Chief Vision Officer at SoundRocket. He is also often found practicing being a husband, father, entrepreneur, forever-learner, survey methodologist, science writer & advocate, and podcast lover. While he doesn’t believe in reincarnation, he’s certain he was a Great Dane (of the canine type) in a previous life.