Can I Get an EUA Too?

Thursday, April 30, 2009

In response to the emerging Swine Flu (H1N1) situation, FDA made news by providing an Emergency Use Authorization (EUA) for a CDC-developed real time PCR test running on the ABI 7500 Fast Dx.

CDC was able to develop this test so quickly, in part, because CDC and AB (with assistance from MyRAQA) just got clearance for a slightly different flu test on this instrument in late September 2008. 

Under ordinary circumstances, you don't get to make changes to cleared products and expect your changed product to be cleared so quickly. But it is safe to say that these are not ordinary circumstances.

In the wake of FDA's decision, I've had a couple different people ask me what an EUA is and whether they can get one too. The short answer is no, you probably can't get an EUA. Not unless you're the CDC or the stars have all come together for you just right.

The longer answer may be interesting to some, however, so here goes...

An EUA, first of all, is not an invitation to hurry through products that would fail to pass muster under ordinary circumstances. As important as it is to have an assay for H1N1, it is every bit as important that the assay be as reliable as possible. People are going to get quarantined based on the results of this test. Precious doses of stockpiled medication are going to get handed out. As quickly as something like this needs to be made available, it also needs to be good enough that it doesn't make the situation worse.

Even in an emergency, it's not good enough simply to have something available. To get a EUA, you must have a kit that has can pass some reasonable amount of scientific muster. There won't be time for clinical trials in an emergency situation, but being able to detect actual samples is a pretty reasonable minimum hurdle to clear. That leads to a bit of a tricky development challenge: How do you get samples?

CDC gets to suit up in cool biohazard gear and do blood draws in the hot zone... but your lab probably doesn't have that option. So to get samples, you'll probably have to get them from CDC... and pulling that off is going to be a neat trick.  For several reasons, CDC will be reluctant to pack up vials of a virulent new pathogen and ship them around the country. CDC would need to work with your company in order to have this work out.

As a practical matter, I wouldn't expect to see this scenario play out very often. CDC still has to do most of the heavy lifting and it's not obvious what the advantages to public health might be. The truth is, CDC can develop that same test as fast as you can, if not faster. By the time you have enough information to get started, they're already finishing up. And they can test actual specimens without having to make any special arrangements.

Logistical difficulties aside, it bears mentioning that an EUA is a limited-time waiver. When the emergency passes, so will the authorization. Even if your kit brings the world back from the brink of extinction, you're going to need to get a 510(k) cleared to continue selling it once the crisis passes. EUA's are not a "Get out of regulatory free" card.

I can imagine a scenario where the stars align perfectly and someone has the exact right test at the exact right time but I don't expect to see it play out now or in the future. It would require a product that's not fully developed and yet has manufacturing capacity that can be scaled quickly. It could happen, but it's not the stuff solid business plans are made of.

That's not to say that EUAs are irrelevant. Clearly, there are several companies who stand to make money on this and it's largely because of actions they have taken. The real lesson here, for manufacturers, is that clearances matter.

It's safe to assume that this EUA means Life Technologies (formerly Applied Biosystems) will sell a sizable number of extra instruments and reagents as part of the public health response to Swine Flu. But these sales aren't the result of having developed a test for H1N1, they are the result of having gone to the effort to obtain clearance for a flu test on their platform.

This kind of outcome can't be predicted in advance, but it helps underscore the significant market advantages of having a robust regulatory strategy. RUO-oriented development is a great way to make early sales, but when important situations arise, the Feds are more likely to put their trust in companies who held themselves to a higher standard.

It's not always obvious in advance how meeting higher standard will help profitability, but cases like this show clearly that there can be important fringe benefits to doing things the right way.

Tags: 510(k), FDA, Policy, RUO

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