I didn’t think we would need a no-expletives policy for this blog, but I’ve recently had to decide that we should have one. Curse words are not normally required in a discussion of IVD regulatory, but a recent change at FDA has left words like “misguided” and “horrendous” feeling a bit too calm. When I heard the story I’m about to relate, I spent a solid hour swearing like a sailor.
FDA released a guidance doc (PDF) on Tuesday that (when paired with its evil twin from last year) creates a communications bottleneck whose needless harmfulness is only overshadowed by its sheer ridiculousness. It’s a new policy so transparently silly that it could only have come about from an act of Congress.
In the old paradigm, the meeting request process was pretty straightforward. First, you generally needed to have some kind of active submission. Once that was in place, the process went something like this:
Reviewer: We should talk.
You: Sounds great. Can we set up a phone call?
Reviewer: Sure. How does Tuesday work for you?
Regulatory professionals of the future may be astonished to read this in years hence… but as recently as Monday of this week, it was the case that if you needed to talk about an ongoing submission, you could just talk. Reviewers were permitted to act like ordinary human professionals who were allowed to keep their own calendars.
On Tuesday, we had our first conversation with a reviewer after the publication of the new guidance. We’ll remove any identifying details here, but the conversation pertains to a 510(k) application submitted prior to Tuesday.
The conversation went something like this:
Reviewer: I have some questions I need to discuss relating to your application. We should talk.
Us: Sounds great, can we set up a phone call?
Reviewer: No… you need to file a pre-Sub.
Us: Huh? This is a 510(k). We already did a bunch of pre-Subs.
Reviewer: I need to refer you to this guidance (PDF).
Us: So… our 510(k) is on hold until we talk, but we can’t talk about that submission until we submit a different submission? With eCopies and everything?
Us: But that could take a week just to create and get through the document center. Then you have (looking it up) 21 days to review the request? That’s a entire month to schedule a phone call! How does this relate to last year's new policy of kicking out submissions that fail to respond to deficiencies within 180 days?
OK, in truth, we only started asking those last two questions once we got off the phone. But you get the point, I’m sure.
It used to make me angry when cynics would claim (against evidence) that FDA was more interested in rules and minutiae than actual medicine or public health. Now it makes me furious that someone at FDA appears hell-bent on proving the cynics right.
I’m told that this change is being made in the name of greater transparency. I’ve never been a big fan of this bureaucratic brain worm and I’m not sure how it even applies in this situation. Even accepting this premise, however, we should push back strongly on the notion that transparency should be achieved at the expense of openness. It is not helpful to see how government works if you make it stop working in order to take a better look.
OIVD/OIR has long been the jewel in CDRH’s crown, a shining example of what governmental effectiveness and mission orientation looks like. It has been a genuine pleasure to work with OIVD/OIR personnel and whether I agree with their conclusions or not, I have always felt that they paid at least as much attention to what advanced the state of medicine as they did to bureaucratic minutiae.
Obviously, somebody feels like they have to put a stop to that.
I should probably submit an official comment to the draft guidance... weirdly, however, this suddenly-more-relevant guidance on communication (PDF) is the same one that FDA submitted for public comment in mid-December and then cryptically withdrew only a few weeks later. It's always been an interesting situation when FDA enforces a draft guidance; it should be even more interesting to see FDA enforce a draft guidance that they have publicly stated is "not finalized" enough to even merit public comment.
As this blog was going to press, our reviewer was thankfully able to offer a good measure of common sense: we were able to obtain informal agreement on a meeting date prior to submitting the formal meeting request. That helps a lot, but it's not clear that submission sponsors would have any basis to rely on such courtesies once the guidance is finalized.
Expect to hear a lot more about this change, if it sticks. I can't imagine that OIR reviewers actually want to behave this way and I hope they still have the ability to push back. We'll certainly do whatever we can to support them.
If this starts happening to more people, however, I doubt I’ll be the only one talking a blue streak. We may need to consider adopting a no-cursing policy for Federal Register comments and public meetings.
Here's hoping that there is still time to reverse course.