Three reasons FDA's enforcement helps mobile health

By Bradley Merrill Thompson

As MobiHealthNews reported earlier, this week FDA sent an enforcement letter to the developer of a urinalysis app. This might sound weird, but I believe that’s good news for the mobile health industry.

Full disclosure, I may have played a part in FDA’s decision to send that letter. Over the last several months, I’ve had four occasions to talk about the app publicly, including:

1. A March editorial on the Medical Device and Diagnostic Industry (MDDI) website in which I began the public discussion by arguing the app required FDA compliance, but had none. Indeed, at the time, the manufacturer was claiming that the app wasn’t even a medical device.
2. March testimony before a subcommittee of the House Energy and Commerce Committee to the same effect,
3. Comments to the media and FDA at an April Politico event after the app made its debut on iTunes, and
4. An interview by the Gray Sheet that published a very detailed story on Monday of this week. Indeed, the Gray Sheet also interviewed two professors to assess whether the app developer had sufficient clinical evidence in support of its claims.

I mention all of this because it seems relevant to the question I’m sure you’re asking yourself, does this FDA letter reflect a new trend by the agency or is this likely to be a one-off event? To me it seems unlikely FDA is now embarking on an enforcement campaign against violative mobile apps, at least until the final guidance is out.  Instead, I think FDA simply decided to respond to all of the public questions around whether apps trigger FDA requirements if they perform the same functions as traditional, regulated medical devices.

So why is this good news? Because the letter gives the mHealth industry, and particularly the segment of that industry focused on higher risk apps, some clarity with respect to the role FDA by law already plays.

There are three basic ways that we in the industry figure out FDA’s rules.

1. Interpreting for ourselves the statutes that Congress has laid out
2. Reading what FDA says
3. Watching what FDA does

With regard to FDA regulation of mobile apps, many in industry feel capable of doing number one, and that frankly leads us to certain conclusions about the scope of FDA jurisdiction. But it’s one thing to arrive at your own personal interpretations about how a statute should reasonably be read. We still look to those in authority to give their own official interpretations.

So everyone has been anxiously (or nervously) waiting to read what FDA says in the final guidance on mobile medical applications. But in the meantime (i.e. the last a couple of years), everyone is watching what FDA does. And what FDA has not been doing, even more than the lack of guidance, is a source of the current confusion.

Please let me preface this by saying how much I respect FDA and the work they’re doing. What they do day in and day out saves lives. Candidly I wish my life had the same meaning as theirs.

But I must humbly say, I believe FDA up till this week was making a big mistake. I perceive that FDA has a very earnest and heartfelt desire to support innovation for which I greatly applaud them.  I believe they do not want to scare people away from the mHealth industry through heavy-handed enforcement. And my hat is off to them for that. Further, I believe they have a laudable desire to be fair and not use enforcement when they haven't plainly stated the rules, so they made either a conscious or unconscious decision to suspend enforcing the basic rules in mHealth even for higher risk apps. But for those higher risk apps, that's a mistake, on a lot of different levels. I will offer three:

1. The most obvious is concern for the patient. Some of the stuff going on out there, and fortunately it is not a lot, could be putting patients at risk. The mHealth industry, in its early stages, would be devastated by a public health disaster that would cast a cloud on all the industry is doing. As an industry, we depend on the confidence of consumers and physicians, and we cannot afford to jeopardize that, in addition to our innate desire to protect and care for patients.
2. Confusion.  I said above we read what FDA writes and we watch what FDA does, much like a parent-child relationship. When the Agency for whatever reason is not able to write a guidance, often times we can nonetheless discern the rules through a combination of reading the statute and watching what FDA does. In the area of social media, for example, while the guidance is long-delayed, I'm not as worried about that because the FDA has continued to engage in enforcement and there are more than a dozen warning letters and untitled letters that in my mind pretty clearly communicate what the Agency thinks should be done in many areas of social media. The Agency has taken the position that there are some practices that violate the Food, Drug, and Cosmetic Act, and the Agency has therefore not waited on its guidance to enforce. (Just to be clear, there are though some very important issues that are still left open and for which guidance is needed.)
3. FDA's lack of enforcement has been harming innovation for higher risk apps.  You might want to read that twice. I'm not kidding. Before this week, in the higher risk segment of the mobile health industry many of us perceived that there was no sheriff in town. This is the Wild West. And in the Wild West, outlaws tended to rule. And respectable citizens from the East, be they bankers or others needed for an economy to thrive, didn't want to move west. I've taken the metaphor way too far, but hopefully you see my point. There are a whole variety of players sitting on the sidelines because they themselves don't want to become outlaws, but they also know they can't compete with outlaws. There are companies that want to do things right, and invest to make important (i.e. moderate risk, high benefit) mobile medical apps using the quality system, taking the time to really develop evidence, and submitting that evidence to FDA as needed.  But no one is going to do that so long as chaos reigns and anyone with a garage can be on the market the next day with a potentially lousy product that doesn't do what it says it will do, even though it is for moderate to high risk use. So right now the vast majority of apps are free pieces of software that don't accomplish nearly what could be accomplished in mHealth with more serious investment. [An important caveat to this is that I'm referencing specifically moderate to high risk products. I absolutely believe that a free market without much if any regulation is best for products that don't carry with them much risk.]
   

So, on the one hand, I understand why FDA has been on the sidelines. But I'm also hoping that now FDA understands that there is a tremendous cost to that. Innovative industries producing moderate to high risk devices can operate within a regulatory framework so long as that regulatory framework is clear, certain and predictable. Unfortunately, until now, FDA had unintentionally taken that away from us not just by waiting to publish a guidance, but more importantly by creating confusion through its inaction in circumstances when action was plainly called for. Those of us watching what FDA does have been absolutely perplexed over the last couple of years because it seems like there's been no rules in mHealth. Yet the rules are still on the books. There are regulations on urinalysis. Have been there for decades.

Requiring traditional device manufacturers to comply with FDA requirements while letting mobile health developers do the exact same thing without FDA compliance can't be good policy. Of course it's possible that the Agency's has decided that it's been over-regulating for years, including traditional devices.  If that's FDA’s view, great, but it means FDA needs to take the formal step of deregulating and not just pulling back on enforcement. The worst circumstance of all for ethical companies is to have a regulatory agency with regulations on the books but not enforce them.  All that does is put responsible companies in a conundrum.

I should say that I absolutely support Christy Foreman’s statement at the Politico event about not wanting to enforce where the rules are unclear. One area where I think the rules are particularly unclear is with clinical decision support software. So I don't want FDA to interpret this as encouragement to tread where the rules don't yet exist in any clear form, in the statute or elsewhere.  But the urinalysis rules are just not ambiguous, and there are many other similar cases.

I also want to say I’m sorry I had to pick a company to make an example of in my public statements.  It seemed to be the only way to get anyone focused on the issue. Last fall I started to talk about this issue generically in speeches, but got nowhere I guess because it seemed too theoretical. The company I named, though, is not alone. There are others doing similar things.

I was gratified to see FDA’s letter to the company was so polite and accommodating. As I write this, it’s only been out a couple of hours, and already I’ve gotten several notes from companies saying, wow, we hope if we ever mess up we get one of these nice, “it has come to our attention” letters instead of the traditional, stern warning letter. I had to do a little research, because I had not encountered such a letter before, and I discovered that FDA has apparently used this type of letter at least once before, with regard to companies selling genetic test to consumers a few years ago.  But they are certainly not the agency’s norm.

Bottom line, I hope FDA’s recent action brings some clarity to the fact that FDA has an existing regulatory structure that covers all technologies, be they the size of a cash register or simply software that sits on a cell phone, if they are intended to be used as a medical device.  It’s my hope that companies interested in higher risk apps will see this as an encouraging sign that FDA is present and ready to act, when the law is clear (and perhaps when prodded).  We need greater investment in the high-end of the mHealth industry where there is enormous potential to do real good for patients. Maybe now we can start to see some of that investment flow.