"In response to these public health concerns, the agency believes it is time to reconsider its policy of enforcement discretion over LDTs. ... At this time, FDA believes that a risk-based application of oversight to LDTs is the appropriate approach to achieve the desired public health goals"
FR Doc. 2010-14654, for publication 06/17/2010
As predicted numerous times here on our humble blog, the reasons for IVDMIA's delay are not, in fact, that it is under NRPM, nor that FDA has lost its battle to regulate LDTs. No, the real reason, it turns out, is that FDA no longer feels the need to bargain with industry. They're just going to release the hounds.
As much of a shift as IVDMIA represented, let's remember that FDA always approached it as a compromise between what industry wanted (some breathing room) and what FDA already had (enforcement authority).
Industry succeeded in running IVDMIA off the rails, but this is a big case of "be careful what you wish for." With no compromise reached from a lengthy good-faith effort to create one, FDA was left with little incentive to deal at all. Their best play was to bide their time until our national appetite for regulatory oversight returned.
It turns out they didn't have to wait too long. Events like the Gulf spill and the Upper Big Branch mine disaster have changed the social context for strict enforcement of existing safety regulations. Pathway's debacle and 23andMe's blunder couldn't have helped, either.
We've gotten accustomed, during the Bush years, to the notion that stonewalling stuff you don't like is a reasonable and effective regulatory strategy. This was always a dubious strategy, but now it's not even a strategy... it's just a tactic, and a short-term one, at that. By engaging in stall tactics, industry lost its seat at the table. What we have now ended up with will be far more restrictive than what we could have had.
The two-track system for regulating IVDs is a legitimate problem that has long required an affirmative solution. FDA has never given any sign that this disparity would be allowed to continue forever. At every public meeting the last five-odd years, they've consistently identified this as a problem that requires a solution. FDA has tried in earnest to engage industry in helping solve the problem.
Today's announcement demonstrates that there is often greater wisdom in influencing things you don't like than in attempting to deny their legitimacy. That's how the Obama administration approaches the world and it's how I would advise our clients to approach FDA.
Oh, and I'd like to offer a warm welcome to all our new LDT readers who are now scrambling for information. I'm sorry your world has just changed overnight. I wouldn't wish that on anyone, and you truly do have my sympathy and best wishes.
You can read more and register for the meeting here.