FDA knows about the problem but hasn’t yet fixed It
With regard to the 2016 software amendments found in the 21st Century Cures Act, FDA knows full well it needs to make changes, but is simply not doing it.
I’m about to be fairly critical of FDA, and before I do that, I want to make sure that I am stating this with appropriate balance. I know a lot of people at FDA, and I consider them among the finest people I know. They are smart, hard-working, full of integrity and care deeply about the health of the public. And I also believe they are earnestly looking for ways to increase medical technology innovation, and the agency’s precertification program is one of the most creative and novel ideas I’ve ever heard. But on this issue — the issue of correcting out of date information on the agency’s website — FDA’s performance is not acceptable. And part of what makes this so disturbing is that the agency is fully aware of the problem and that’s not enough for the agency to act.
During an August 1, 2017 discussion of the Digital Health Innovation Action Plan, FDA said that it would withdraw certain regulations and amend others to implement the 21st Century Cures Act in 2017. But then 2017 came and went.
On the slide below, on the right-hand side FDA notes the need to change its regulations in 2017. On the left-hand side, the agency notes its plans with regard to guidance documents. Significantly, the slide does not even mention the need to change the guidance documents I listed above. FDA was only focused on new guidance, not correcting old guidance.
In a May 10, 2018 presentation, through icons, FDA’s slides suggested the agency was on target to make those changes in 2018.
Yet 2018 came and went, and still no updates to the regulations.
With regard to FDA’s guidance documents, the agency never even bothered to express a timetable for updating the old guidance documents, just publishing the new. As already mentioned, FDA has flagged several of the guidance documents that need to change, and identified at a high level the changes that need to be made, but that’s where the effort stalled out.
Merely identifying the documents that need to change means that it is all too easy for entrepreneurs to get ahold of an outdated document and not understand its inaccuracies. While FDA has added a cover sheet with a warning that the guidance is in some unspecified ways out of date, if the entrepreneur isn’t familiar with the statute, it is easy to not understand what’s wrong with the document.
To be fair, in a sense FDA started the process of amending the existing guidance documents, but did so in a strange and frankly improper way. Rather than publish proposed changes to the guidance documents that need to be updated, FDA published one proposed guidance document that announced that the agency would eventually make changes to the existing guidance documents. I gather they did that because somehow it’s cheaper to publish one proposed guidance for comment rather than several, even though the agency will ultimately need to publish revisions to the existing guidance documents.
But in the land of FDA guidance, that was a horrible mistake, because FDA tends to leave draft guidance as draft for endless periods of time. FDA has been known to leave guidance in draft form for more than a decade. In this instance, apparently now we need to wait for FDA to finalize the draft guidance that covers all of the updates needed to FDA’s guidances resulting from the 2016 legislation, and then wait for FDA to actually make the changes to the affected existing guidances. So potentially for years, those out-of-date existing guidances will sit on the FDA’s website — being misread — until the agency gets around to doing something about it.
As already mentioned, there is a second issue, in addition to the need to update regulations and guidance to conform to the new statute. FDA has decided not to enforce certain existing regulations. The agency expresses that decision in the form of a guidance document that declares that the regulation is subject to what the agency calls “enforcement discretion.” But to an entrepreneur who finds only the regulation, there isn’t even a warning that the regulation is not being enforced. The wisdom of FDA’s use of enforcement discretion is something I challenge in a separate blog post.