Annas: Time for ‘Serious Dialogue’ about Genetic Testing.

The November warning by the Food and Drug Administration  ordering the company 23andMe to cease marketing its personal genetic-testing kit should serve as an opening for policy makers to create a “regulatory framework” for the growing genome-sequencing industry, BUSPH Professor George Annas and a colleague write in the New England Journal of Medicine.

Annas, professor and chair of the Department of Health Law, Bioethics and Human Rights, and Dr. Sherman Elias of the Department of Obstetrics and Gynecology at Northwestern University’s Feinberg School of Medicine, say the FDA’s action was justified, given that the company had not shown that it had clinically validated its testing system for its intended uses.

“That is traditional consumer protection and what the public expects from the FDA,” they said.

But they also argue that the resulting marketing shutdown provides the “opportunity for serious dialogue that could be a basis for setting standards not just for 23andMe, but for the entire industry.”

As the cost of genetic sequencing continues to fall, they write, “millions of people will probably have their genomes sequenced. That will turn out to be the easy part. The difficult part will be, as it is today, the clinical interpretation of an individual’s genome and the making of useful recommendations to the patient– consumer. Put another way, the heart of this debate is not the cost of the sequencing . . . but rather whether the information produced can be used in ways that improve our health.”

Read the full “Perspective” piece here: http://www.nejm.org