By Bruce Japsen and Sandra M. Jones | Walgreen Co. reversed a decision to carry genetic test kits in its stores after the U.S. Food and Drug Administration began looking into the supplier.
The Deerfield-based drugstore had planned to begin stocking its shelves with the Pathway Genomics home test kit on Friday, as reported by the Tribune yesterday. Walgreens’ decision was announced within hours after the FDA released an enforcement letter sent to San Diego-based Pathway giving it 15 days to respond to the agency’s request for information regarding its controversial genetic home test kit.
“In light of the FDA contacting Pathway Genomics about its genetic test kit and anticipated ongoing discussions between the two parties, we’ve elected not to move forward with offering the Pathway product to our customers until we have further clarity on this matter,” Jim Cohn, a Walgreens spokesman, said late Wednesday.
In a letter dated May 10 and released this evening, FDA Deputy Director for Patient Safety and Product Quality James Woods said the agency has been “unable to identify any Food and Drug Administration clearance or approval number” for the product.
The kit, sold under the brand name Insight, comes with a vial and a shipping envelope. Buyers send a sample of their saliva to a Pathway Genomics laboratory, and receive their genetic health report online for a fee.
“If you do not believe that you are required to obtain FDA clearance or approval for the Genetic Health Report, please provide us for the basis for the determination,” Wood said in his letter to Pathway Genomics.
Pathway was scheduled to start selling its genetic home test kit at Walgreens drugstores Friday and CVS stores in August. The home tests claim to assess the risk of dozens of health conditions, including Alzheimer’s disease, breast cancer and heart disease. But some scientists and physicians worry consumers will misuse or misunderstand the results of the tests.
Pathway officials have said they believe the test is in compliance federal regulations.
“Pathway works very diligently to ensure that our business is compliant with all applicable regulations and guidelines,” Pathway said in a statement issued Wednesday in response to the FDA’s inquiry. “Our laboratory is federally CLIA-certified and state-licensed. We have provided the same personal genetic report to customers for the past year, and are continuing discussions with the FDA about the regulation of personal genomic information.”
C’mon Walgreens!Show some backbone!
Interesting. So to take this down the conspiracy road…..once they have my dna will Pathway or their parent company sell the information? If I have some “special” attribute will some agency come hunt me down to “obtain” it? Give it to insurance companies and I will lose coverage or expect a rate hike in the future? Hmmmm is “knowing” worth it?
I wonder why they decided to carry this product in the first place? Knowing that it wasn’t FDA approved- it’s a little scary that they would think about putting it on their shelves in the first place.
It is also kind of irresponsible as a “healthcare” provider to put this kind of thing out there. Here’s a test that may show you have a predisposition to cancer( etc) and you can deal with that at home.
If you seek this kind of test with your doctor there is mention of counseling and the results are read by a professional. It seems kind of sleazy for a pharmacy to offer this type of item.
I hear that the kit comes with a rope, so if the results are too depressing, you can hang yourself.
It concerns me that Walgreen’s is also sells prescription policy/coverage to many large corporations. Pharmacies are part of our health care system. It seems kind of irresponsible to be involved in hawking these type of products in the first place.
“Amid controversy” They are not moving forward.. uh- cause the FDA started looking into it.. otherwise it was a go..
No one thought- What’s the reliability of this product? before now? (a test saying you might have cancer, parkinsons’ etc is pretty extreme). What about the customer purchase records and test result information for this product- how were they going to handle that? It nice to know that they gave the product so much thought- a pharmacy America can trust?
I think they are showing some backbone!