I have been following health care consumerism for several years now. Particularly, the “Direct Access” or “Direct To Consumer” laboratory testing market. While analytic lab testing has led out in this area, genetic testing has received all the regulatory attention, national press, and policy efforts (GINA).So it is no surprise that consumer genetic movement would be the first legal test of the Health 2.0 movement. As reported by Matthew Holt here on THCB, and a host of national outlets (Wired has had extensive coverage here, here, and here), there seems to be quite a hornets nest unleashed by our friends at the California and New York Departments of Health who are attempting to prevent consumers from accessing their own genetic information.
Thanks to some transparency efforts of the blogosphere, you can read the actual cease and desist letter written by Karen Nickels, the California Department of Pubic Health Chief of Laboratory Field Services. I actually know Karen Nickels personally. She has been a long time steward of ensuring regulatory exactness of all things laboratory within the State of California for 30+ years. She has a well deserved reputation as one tough cookie for the “precision” with which she carries out her dutiesUltimate Genetic Fighting – Which Genetic Variation Wins?
In my interactions with her, she was succinct, well versed, and uncompromising on her interpretation of the letter of the law. With great effort, and mutual patience, I was able to convince her that the letter of the law has fallen way behind the speed of technology and that adaptations would need to be made to the consumer laws to account for the new direct to consumer analytic testing market. To her credit, she was able to recognize my points and make accommodations that acknowledged some technical advances yet remained consistent within her interpretation of the current regulatory framework.
Unfortunately, the letter which has been made public seems to once again misjudges the product offerings, misunderstands how the solution is offered, and misinterprets the situation while regressing back to a very narrow interpretation of the law and myopic view of consumer testing.
Here is the nuts and bolts of the letter:
- All clinical labs receiving CA specimens or processing specimens originating in CA must possess a valid CA clinical laboratory license or registration (CA Business and Professional Code Section 1241).
- Consumers are prohibited from ordering tests (with a few FDA approved exceptions) without a physician order (CA Business and Professional Code Section 1288).
- Finally, in order to obtain a CA clinical laboratory license, organizations need to provide satisfactory documentation to verify that laboratory tests being offered meet performance specifications.
These are all well and good and reasonable requests from the regulatory agency. Unfortunately, the CA Department of health immediately leaps to the conclusion that these companies don’t possess a license or a physicians order and therefore must not be meeting the requirement. Furthermore, in the most egregious abuse of personal liberty, the letter goes on to say that GENETIC TESTING IS PROHIBITED FOR CALIFORNIA RESIDENTS.
I salute Navigenics and 23andMe as they give their own form of salute to the CA Department of Health. These companies are absolutely RIGHT and the CA Department of Health is absolutely WRONG in this case.
Navigenics and 23andMe use third party labs that ARE licensed by CA regulatory bodies to process the genetic samples and perform genetic testing. I am certain that these labs absolutely meet every criteria and CLIA performance specification accepted by the CA Department of Health. Furthermore, I am positive that both Navigenics and 23andMe have CA licensed physicians who approve consumer orders and release results to consumers all within compliance of every CA law governing physician fudiciary duty. And finally, as a consumer, I want to let the CA Department of Health know that I have every constitutional right to order any test I want (particularly when I am paying for it) that does not cause me direct harm, inure harm to others, or misdirect scarce public resources.
Having met the criteria above, on what basis does the CA Department of Health have to issue “Cease and Desist” letters to these companies? They are concerned that the tests costs too much? They are concerned about false marketing? They are concerned about accuracy of labs THEY have already certified? It’s actually quite embarrassing given that the Department has completely misunderstood how the process works and how technology is enabling people to learn more about their health than ever before.
The appropriate solution is for CA Department of Health to create a forum where their regulatory concerns can be aired out, and the companies can explain to the department how their technology, the business models, their testing and compliance framework, and their overall objectives are consistent with the laws. Navigenics CEO Mari Baker has just requested such an opportunity.
Conversation or Cat Fight? Two fiercely independent woman. One intractable issue. Millions of dollars at stake. Tens of millions of people watching. Vegas odds, anyone?
Lets get ready to Rummmmmbbbble!
Can you please point out the sentence in her letter that says genetic testing is prohibited for California residents? I read the letter twice and don’t see it (although it is hard to read without a microscope.)
At the risk of repeating myself in comments on previous posts on this matter, there is nothing new or unusual in this letter from a regulatory agency to a laboratory. As a former medical laboratory director, I can certify that these are standard requirements and are directed toward protection of the patient (or “consumer”, if you must) from substandard quality laboratory testing.
Just because the outsourced third party lab has a license isn’t enough. Note her letter says “….or receive biological specimens….” These companies are receving biological specimens. Who is assuring that they are not contaminating or otherwise damaging these specimens before they reach the third party, licensed laboratory? For instance, suppose the specimen has to remain frozen at a certain temperature during transport, or has to reach the testing lab within 48 hours before it deteriorates; who is assuring that?
Again, one may see conspiracy in this action, but it is nothing more than a government doing what governments do – enforcing the rules as it sees them. Personally, I don’t think it’s a bad idea since profit making companies will cut every corner they can in this field and someone must be supervising them.
As for the necessity for a physician’s order, yes, one may quibble with that as being outdated. However, it again is standard nationally, not something dreamed up to persecute genetic testing companies! Know whereof you speak before misleading people.