OIVD Director Alberto Gutierrez made some comments this week that have caused quite a stir in the dignostics community. Judging by this GenomeWeb story, IVDMIA will be delayed at the minimum, and may even be back to "square one."
On the face of it, this sounds like a capitulation to industry. For how long this has been in process, delay is about the same thing as giving up. Some players are already jumping to the conclusion that a blind eye has been turned and that they are welcome to return to business as usual.
I have some concern that FDA is stepping back from IVDMIA, but I'd offer a strong caution against reading any specific message into the "square one" comment at this point. While it seems likely that IVDMIA is coming off the table, it's not the least bit clear that FDA intends to maintain the status quo.
Remember, this isn't a case of the government against industry. Many key members of industry have a problem with the two-track regulatory system too. Lab test startups and their investors may be enraged at the idea of increased FDA authority, but the larger and more established players want this loophole closed as soon as possible. FDA has the political winds at their back and enjoys broad support in industry. It is prudent to assume that something is going to happen, even if it's not IVDMIA, per se.
Dr. Gutierrez has stated numerous times in public meetings that he sees the two-track system as a significant problem. He has characterized the system as an "uneven playing field" and even remarked that it is bad for business. Apart from the "square one" comment, I have no sense that he intends to capitulate. I suspect something else may be going on.
I have no inside information about what might be going on behind the scenes at OIVD. I can think of at least three scenarios, however:
- This is simply a delay. The health care financing debate is running very hot right now and FDA may simply have been asked to back off on introducing new rules for a while.
- There could be a larger plan in the works. Perhaps FDA is backing off because CMS may be about to step up to the plate and exercise stronger authority.
- It could be that IVDMIA no longer represents the best compromise FDA thinks it can get. They may be going back to the drawing board because they intend to assert broader authority over lab tests.
As I said, I don't have any actual information here, these scenarios are just speculation. That said, nothing I see in the public record rules any of them out as a possible explanation.
Companies looking to skirt FDA's authority appear to have won the day. No doubt there are a congratulations being exchanged and CEOs filled with the sense that their brinksmanship caused the enemy to blink.
They have some reason to celebrate: the status quo will probably be maintained for at least the next few months. But I think it's too early to jump to the conclusion that this is over. FDA is probably executing a strategic retreat, not signaling their surrender. it might be wise to keep the champagne corked, because the real battle may only have just begun.