At the end of every year, CDRH publishes a list of the guidance documents that they plan to put out in the following year. The list contains the plans for both final and draft guidance documents. The list consists of topics and a relative priority ranking parsing the guidance documents onto an "A" or "B" list. What makes the plan interesting is that it can give some insight into how the agency is thinking, and what the priorities might be for the next year.
We had originally intended to blog about the list at the end of last year. We had some cute ideas about life on the "A" list, and speculated on whether the "B" list guidance documents were jealous of (or maybe teased by) the "A" listers. But then frankly, we got really busy. As last year bled into this one, and weeks turned into months, it seemed that the window for writing a blog on the list of guidance documents planned for 2013 was closing. After all, it is nearly the end of the first quarter and at least two of the guidance documents on the “A” list (e-copy and RTA) were published at the end of last year.
But then things got weird. It started with the agency enforcing the Pre-Sub draft guidance before it was final, something they typically didn't do in the past. Then last week the latest draft guidance on communications during submissions hit, and also got implemented. You can read about the fall-out from that in an earlier blog. So we decided to go back to the list for a second look.
On the "A" list of final and draft guidance documents are topics like the 510(k) and PMA filing process, mobile apps, pre-subs, IDEs, e-copy, and the long awaited final guidance on in vitro companion diagnostics. Conspicuous in its absence is an LDT guidance document - any LDT guidance. Remember when LDTs were the hot topic a couple of years ago? How FDA talked about its authority to regulate LDTs, and that there were rumors of guidance documents to come on the subject? Now, the only thing that comes close is a proposed draft guidance on our old friend DTC (Direct to Consumer) genomics testing, and that is on the "B" list.
Traditional diagnostics companies have been complaining for years about the unfair regulatory environment that exists for them. How are they going to feel now that the communication and submission process with FDA just got more onerous? And how many business plans for start-ups that were teetering between a distributed test and an LDT just tipped to the side to the less regulated side of the fence?
But there are other, potentially significant implications of a more complex submission process as well. Remember companion diagnostics and the promise of personalized medicine? Drug companies were already having a difficult time getting diagnostics companies to take on the effort and risk involved in a companion diagnostic project. Now add the additional time and cost of a more complicated submission process, and the number of diagnostic companies willing to take the project on gets even smaller. And the LDTs that were considering entry into the companion diagnostics market are probably re-thinking the opportunity, especially since they continue to remain outside the regulatory bubble.
At the very least, it's likely that the price for developing a companion diagnostic just went up. Drug companies will now have to consider if they want to pay the extra costs, assuming of course that they can find a suitable partner. The result could be that some promising drugs get delayed or placed on the "B"-list. And there's nothing cute or funny we can say about that.