The FDA is awake and on the job.

Fortunately, before Walgreen’s started selling consumer genetic kits on Friday, the FDA notified the company, Pathway, that it challenged the legality of selling this test without its approval. Walgreen’s position is clear. The FDA can decide.

Pathway officials probably are unhappy about this development. However, the FDA may be saving Pathway from what has to be a class action lawsuit just waiting to happen.

In our opinion, the company’s announced plan reflected a lack of understanding of the nature of these tests and the serious effects they may have on people’s lives.

Pathway promised telephone support for buyers before they used the test and afterward. Who would be doing this customer support? Qualified genetic counselors? There are not enough of them as it is. Pathway really may not know what “after” is like for someone who has learned devastating news about a genetic-linked medical risk. Was Pathway really ready to provide  hours of counseling to patients who just learned that they carry genes which, for instance, should not be passed on to children? How was this going to work for the people who got the worst kinds of genetic news? They did not say.

The company also assured the public that their privacy would be protected. The company did not say how it intended to protect the most personal medical information of all—what we are made of.

One security breach and, literally, all of the customer’s secrets would come tumbling out of Pathway’s computer.

Pathway planners should have been more careful about lunging into this business as if it were a consumer service.

The FDA may be about to save Pathway hundreds of millions of dollars in litigation costs.

The FDA also is protecting the medical privacy of the American people.

The FDA also is taking the right steps to evaluate this product as the medical tool that.

If reason prevails, the test does need FDA approval before selling it.

Stay tuned.

The New York Times

“Walgreens said late Wednesday that it would postpone selling a personal genetic test through its drugstores after the Food and Drug Administration challenged the legality of the test.

“The developer of the test, Pathway Genomics, said Tuesday it would sell its product through Walgreens starting Friday. While similar tests have been sold over the Internet for more than two years, this would be the first such test sold through drugstores, making such testing more accessible. (Emphasis added)

“That appeared to catch the attention of the F.D.A. In a letter to Pathway that was written Monday but made public late Wednesday, the agency suggested that Pathway’s test needed regulatory approval before it could be sold.”

…”The F.D.A. is also looking at the legality of similar direct-to-consumer genetic tests, an agency official said.“ (Emphasis added)

Source: New York Times, May 12, 2010