On Wednesday, the Food and Drug Administration (FDA) suddenly decided to impose their regulatory authority on personalized genetic test kits after Walgreens and Pathway Genomics announced they'd be selling them in local pharmacies. But, what triggered this response from the FDA?
* Are they new? No. These kits have been available to consumers via the Web for three years.
* Have they been off the regulatory radar screen? No. As far back as 2008, the rapid emergence of genetic testing fueled the passage of GINA, a federal law prohibiting health insurers and employers from discriminating on the basis of genetic information.
* Have these companies been quietly launching their strategy and staying invisible? No. They have made major investments in marketing with an abundant amount of media coverage in women's magazines and news shows.
So, why did the FDA choose to take a stand now?
Maybe the agency was dealing with higher priority issues. The FDA is busy and constantly putting out other fires, resources are limited, and the number of people buying these kits off the Web has been relatively small. But, with the announcement that kits would available in 6,000 local pharmacies, they may have been concerned about a surge in use and the need to fulfill their responsibility to protect the public. A "noble" act, I am sure.
But, were there other underlying forces? Who was nudging the FDA? And, why?
The American Medical Association recommends that "genetic testing only be made available under the supervision of a qualified health care professional."
Hmmm... the most powerful lobbying organization within the traditional medical establishment believes that only clinicians should be the keeper of the keys to our personal DNA information. By the way, does "qualified" include mean nurses, pharmacists, and licensed genetic counselors...or is it really just a code word for "doctors?"
Is the AMA advocating for better health and the rights of consumers, OR...
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