FDA Regulation of Direct-to-Consumer Genetic Testing Update


Last year, the Food and Drug Administration decided that allowing consumers access to their genetic information by means of direct-to-consumer tests might somehow be dangerous. The agency sent threatening letters to leading test companies and launched a series of hearings with the goal of imposing regulations on the nascent industry. The FDA held one such hearing earlier this week. Naturally some people testified in favor of maintaining genetic ignorance, but GenomeWeb Daily News summarizes some heartening testimony from Yale School of Medicine Professor David Hafler who

… suggested in his submitted comments that although personalized genomic technologies are new, they are growing more useful and they should not be restricted to prescription-only status.

Hafler, who is chairman of the university's Department of Neurology, stated that new research suggests that the concern that patients will develop anxieties from having their genetic information appears to be "unfounded."

Having such information also could be beneficial, he added. Recent research "indicates that having one's own genetic information can spark interest in health care and a greater intent to undergo screening tests," he said.

Hafler advised that better and more engaging genetics education will be helpful in avoiding some of the potential pitfalls of consumer genetics, and he added that leaving such testing only to doctors may not assist in that goal.

"In reality, a prescription requirement will silo the information into something only the physician understands or needs to think about, as many feel today about a number of different results they get back," he explained. "I wish to give ownership and with that responsibility of [genetic testing] data back to the patients."

Hafler also said that with more than 3,500 genetic associations already available, "the best use of the FDA's time then is not in regulating every single interpretation of genetic information.

"Give our patients the opportunity to make their own decisions while having the FDA instead focusing on setting up frameworks to ensure analytical validity for the technology and protecting consumers in a general way against misleading information," he advised.

Hafler is just about exactly right.  

The FDABlog* released this telling video yesterday of FDA Center for Devices and Radiological Health director Jeffrey Shuren apparently lying to a Congressional oversight committee last year about the research DTC companies are doing.

See also my happy adventures in direct-to-consumer genetic testing in my article, I'll Show You My Genome. Will You Show Me Yours?  If you're interested, go here to browse through my genetic information. And finally, see my column, Bioethicists Can't Handle the Truth, which shows that normal people have no problem handling genetic information that suggests they have greater risks for illnesses such as Alzheimer's Disease and breast cancer. 

One suggestion: Before regulating, why doesn't FDA commissioner Margaret Hamburg send off for some DTC genetic tests herself and see if they frighten or confuse her? I bet they won't. 

*Kudos to Michael Lee.