Mass layoffs at the U.S. Department of Health and Human Services (HHS), including the Food and Drug Administration (FDA), will impact the medical device regulatory process, says Ben Wolf, partner in Alston & Bird’s Health Care Group.
Wolf, an FDA attorney, sat down with MobiHealthNews to discuss how staffing cuts at the Agency could lead to longer review times for medical device approvals and his advice to streamline the process and minimize delays.
MobiHealthNews: What is your background in medical device regulation?
Ben Wolf: I’m a former medical device engineer. I ended up in law school, always with the goal of doing law in the FDA space. I spent about three years at the FDA after law school and have been in private practice since.
My practice spans every area regulated by the FDA, although with a predominant focus in postmarket issues, whether it be inspections, warning letters, medical devices, regulatory counseling and tobacco work.
MHN: How do you see the regulatory environment changing for medical devices due to layoffs at the FDA?
Wolf: With so many things happening, it is really hard to gauge exactly where the new administration’s focus is as far as areas that they want to emphasize or de-emphasize.
Obviously, with the cuts, there is going to be a slowdown at the FDA in some capacity that could show up in one or more of a few different ways. For instance, we may see the same focus as before, but everything moves more slowly. There may be a de-emphasis in certain areas or deregulatory actions, and in the areas that are not deregulatory, things may stay the same, speed or even accelerate.
The announcement that these cuts at the FDA were going to be focused not on the review or inspection space was heartening. I have heard anecdotally that there has been some headcount reduction in the review space. So, we’ll see how the administration addresses and adjusts for that.
I would say the laboratory-developed test decision out of Texas is likely to help things just by the sheer fact that there was going to be or need to be a large number of applications reviewed and labs that would need to fall under FDA inspection, which, unless the FDA appeals and wins, will no longer be required. So, that should free up resources that the FDA that maybe had been earmarked for those purposes that now they can use for the rest.
As far as the specific product areas, it is really hard to say at this point. We’ll see as the FDA reaches its new normal based on its revised headcount, we’ll see where the action really is, and the industry, I’m sure, will respond, as will attorneys and other counsel, whether that be technical advisors or the like.
MHN: Do you think the layoffs within the FDA and HHS will cause a ripple effect, elongating the process of obtaining FDA clearance? Or do you think that due to the overload, things may move at the same pace, but with less detail and thorough review?
Wolf: Yeah, really either of those could be the case. FDA’s procedures for review and their standards for review are pretty well set. So, I think we would be more likely to see a slowdown in action on applications.
A lot of the costs of doing those reviews is borne by industry through the User Fee Programs. So, we may see pushback from the industry, both to the FDA directly but also to the administration, and we have seen a little bit of that already.
Companies rely on getting these decisions and moving forward and they have a long history of expectations on how long certain application types will take and having a good line of communication with the Agency in advance.
There has already been some pushback from industry groups who are concerned that these cuts may end up resulting in slower approvals. It is entirely plausible that that will result in a reversal of some of these head counts or shifting of resources, where we may see some people hired back or new people hired or people moved within the Agency from areas that perhaps do not have the same level of headcount requirements.
I think there is going to be a short term disruption, but there very well could be a long-term new equilibrium that does not look too much different than the current state of affairs, at least for certain product areas, certain high-priority things.
The hope is probably that the Agency will find efficiencies and will be able to do more with less or at least do nearly as much with less so that things will not be impacted.
I know that the folks at the FDA work very hard by-and-large and so only time will tell whether that fares out.
MHN: Given your background as a former medical device engineer and your experience working with the FDA, are there steps companies can take internally to help streamline the regulatory process?
Wolf: Yeah, and this is something that we preach all the time to our clients in the pre-market space, regulatory council in general and postmarket space inspection and the like–it is critically important and never before as much as it is now, it is critically important to be clear and concise with the FDA. Give the FDA the information that you know they need and ask clear questions if you need clarification.
I would expect there will be limitations on how many meetings the FDA can run just from headcount reduction, but they should take advantage of any opportunity they have to get additional information.
It really is incumbent on companies to be really clear and concise with their requests, with their applications. The FDA should not have to parse anything; they should have all the material they need in a way that they can access it. That will really help the reviewers to assess applications quickly and efficiently and reach a decision.
And, again, that is true not just for applications, but if you are responding to, you know, an FDA 483 after an inspection or warning letter or any other communication with the FDA; the clearer you can be, the more likely you are to get the desired result because the FDA will not have to guess.
