Following up on the rumours I posted about yesterday regarding a potential bid by the FDA to choke of direct-to-consumer genetic testing companies' supply of genotyping chips, I received the following statement by email from 23andMe's PR firm:
23andMe is engaged in an ongoing process with the FDA.
23andMe understands that Illumina is also engaged in such a process.
23andMe has no reason to believe there will be an interruption in the supply of Illumina chips at this time.
I understand we'll have some more clarity on this issue from the FDA tomorrow.
I guess the FDA don't do clarity. This story does not look like it is over yet, see Mary Carmichael
Right. But as part of that deliberation process, when you guys are considering whether to approve a device or not, do you take into account the cost that would impose on companies or the general impact on the industry?
AG: No. No. Our review does not, no, we donât take into account cost.
EM: And Mary, that cuts agencywide. That is not considered in any of our reviews.
What the heck? The FDA doesn't take costs into account? Huh?
How are we supposed to control costs in healthcare then?
If this is an 'agency wide' policy this is a serious issue and much bigger than DTC.
Their clarification is also clear as mud
Okay. Thank you. I thought I had seen some obscure law saying there was a requirement to take into [account] costs â¦ Yes. Here it is. This is actually on the FDA Web site: âAs part of its mission to supply economic analysis to decision makers, the Economics Staff in the Office of Planning conducts economic analyses of all important proposed and final regulations issued by the Food and Drug Administration. Each economic analysis includes an assessment of the costs, benefits, and cost-effectiveness of the action.â So this is right on the Web. How can you not takeâ
AG: So that is just, if you look at the first part, that is for all new guidances, for new rules and regulations.
EM: Which this is not.
AG: This is neither a rule nor a regulation.
So...they are relying on a creative interpretation of the law which allows them to vastly expand their authority to cover thousands upon thousands of clinical labs without actually going through any kind of formal rulemaking process, or doing even the most BASIC evaluation of costs and benefits!
Forget about DTC...someone get CAP, ACLA, AMP, ACMG on the horn, because this sure looks like the basis for a class action lawsuit.