Are special interests trying to sidetrack FDA final guidance for mHealth?

By his own admission, Bradley Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green, has spent 27 years "attacking" the U.S. Food and Drug Administration. At the firm, Thompson counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues, according to his bio.

In addition, Thompson (pictured) is the mHealth Regulatory Coalition's general counsel and in that capacity assists the MRC with the development of the trade association's policy and government relation strategies. In June, he sent a letter on behalf of the MRC to U.S. Department of Health & Human Services Secretary Kathleen Sebelius urging her, through the the FDA, to publish the final guidance on mobile medical applications "as soon as reasonably possible."

Moreover, Thompson co-chairs a Food and Drug Administration Safety Innovation Act (FDASIA) sub-workgroup with Julian Goldman, medical director of biomedical engineering for Boston-based Partners HealthCare. FierceMobileHealthcare spoke with Thompson about the current regulatory environment and his work with MRC and the FDASIA sub-workgroup.  

FierceMobileHealthcare: It seems like there's so much going on lately on the regulatory front as it relates to mHealth. 

Thompson: Well, yes and no. There's a lot of activity. I don't know about progress. That's the sticky part for me. We're hoping to see the final FDA guidance on mHealth. It's two years and counting since they released their draft guidance and so that's a bit frustrating. I agree with you, though. There's a lot of activity.

FMH: Do you think the delay in the release of the FDA's final guidance is negatively impacting investment in the mHealth market?  

Thompson: I do. But, how do you quantify it, except anecdotally? I'm kind of relying on word of mouth. There are people who interpret the delay, especially the delay, as a change of heart and potentially a change of direction by the FDA and that it doesn't know what it wants to do. In that context, then, it makes some people squeamish about making major investments not knowing what's going on with FDA and why it's taking so long. The delay, in a sense, is making the uncertainty worse.

When the FDA draft guidance first came out, it was a pretty good time for investment because people could read it, interpret it, understand where FDA is going and make some decisions. Now, the longer that finalization is drawn out, people are asking: what's going on? Has something changed? Is FDA going to go in a significantly different direction? So, the delay itself is very problematic.  It's causing a lot of confusion and anxiety. As you'd expect, it's most acute or most felt by the higher risk apps. The developers of the low risk apps understand that FDA has no plans to regulate them and they're going merrily on their way. But, the apps that are more in the breakthrough category of things that could radically change healthcare are different. Admittedly, they have more risk associated with them. Those are the ones that are really caught in the conundrum. 

What FDA is trying to do is issue a guidance that they've been working on for a few years to explain in layman's terms exactly where the lines are drawn. The guidance isn't written for me. It's something designed to help the entrepreneur and people who are developing these apps to be able to go to the FDA website, read it and figure it out for themselves.       

FMH: In March, Christy Foreman, FDA's Director of the Office of Device Evaluation, testified before Congress that the agency will issue its final guidance on mobile medical applications by the end of fiscal year 2013. Is pessimism that the FDA will in fact meet this goal warranted?  

Thompson: I'm an optimist by personality and so I'm still optimistic that it will happen. Christy didn't know and couldn't foretell that months later 120 organizations would join together and sign a politically-charged letter to HHS Secretary Sebelius telling her to stop. The FDA and HHS are really getting some mixed signals from us and others. On the one hand, they're hearing: go, go, go! We need to get this resolved and we want industry to be untethered by the uncertainty. And, then, 120 organizations tell them to stop. I don't want to get over confident and think that it couldn't have an impact on what happens. Politics sometimes trumps logic. The fact of the matter is the FDA is trying to do the right thing. They're being stymied politically in what they're trying to do. 

FMH: In an MRC position paper that was included in your June 21 letter to HHS Secretary Sebelius, you raised concerns that the FDA might delay the release of its final guidance on mobile medical applications until after HHS develops its comprehensive regulatory strategy for all health IT as required by FDASIA. Do you still have that concern?

Thompson: In the debate world, that's what you call a rebuttal point. I was raising that because I understood that organizations around Washington were arguing that FDA ought to hold off until the FDASIA working group had finished its work and the agencies had collectively published their report back to Congress in January 2014. So, to rebut that point, I included that description in the letter that I sent to basically explain that they serve entirely different purposes. 

The FDA draft guidance was actually deregulatory in nature. That is, things that before July 2011 that I and others, including people at FDA, would have said is regulated, that document sought to unregulate them. So, you've got a deregulatory document trying to clarify at a pretty granular level the scope of the existing statute--the Federal Food, Drug, and Cosmetic Act--that has nothing to do with the strategic issues the FDASIA working group is being called to discuss.

Back when this FDASIA thing was put together, everyone made the connection and the question was asked: should the FDA go ahead with its guidance document? It was discussed at length at that time and one of the first drafts of the legislation said there would be a moratorium and FDA would not be allowed to publish its final guidance until after the FDASIA group had done its work. We talked about it, rational heads prevailed, and Congress said 'no, we're not going to tell FDA to hold off publishing that final guidance because it's too important that it gets out.' We talked about all of this over a year ago in May 2012 as the FDASIA legislation was being developed. Now, we've got a bunch of sore sports who lost that debate trying to reignite it.

FMH: Having said all that, do you feel the FDA's final guidance is being sidetracked by the FDASIA working group's development of a strategy for a risk-based regulatory framework that governs health information technology (HIT) including mobile medical apps? 

Thompson: It's not being sidetracked by the FDASIA work. It's being sidetracked I fear by special interests in Washington who are lobbying the Administration to sidetrack it. I'm not talking about people on the working group, but people outside who are trying to use the existence of the working group for that purpose.

It's the same old tactic that so many people use in Washington, which is delay, delay, delay, in order to let special interest groups work their magic through other alternative processes. ... They keep saying "slow things down, we're going too fast."

The fact of the matter is, though, that two years to debate something like an FDA guidance document of this relatively benign character is absurd. No one's going too fast. We're going too slowly.  

FMH: What is your connection to FDASIA? Am I correct in saying that you are co-chairing a FDASIA sub-workgroup?

Thompson: With Julian Goldman, I co-chair the regulations subgroup.

FMH: The FDASIA subgroup on regulations is sending tentative recommendations to the FDASIA workgroup for consideration, before those and other ideas go to the ONC's HIT Policy Committee and then the FDA. What is the process?

Thompson: The subgroup that Julian and I co-chair wrapped up its work on July 19. We sent a report to David Bates, the chair of the overall workgroup. At this juncture, he's going to take the output of all three subgroups and meld it together into one singular report that will be the report of the whole workgroup. We've got a call on [July 26]  to look at the first draft of the report. We're done with our subgroup and now we've got about two meetings I think scheduled to try and come together with a report on behalf of the whole body before the ultimate report gets delivered to the HIT Policy Committee. 

FMH: The report of the whole FDASIA workgroup is a work in progress, but what were the specific recommendations of the FDASIA subgroup on regulations? 

Thompson: The subgroup put together a pretty detailed PowerPoint presentation of about 15 slides. We made a variety of recommendations. For example, with regard to FDA, we recommended that several areas be clarified. One area is the difference between wellness claims that are not regulated and disease-related claims that are regulated. The second area is the scope of FDA's so-called accessory rule which says that anything that connects to a medical device becomes a medical device. The fear is that a lot of mobile health stuff ultimately will be connected to a medical device and be swept within that rule. We asked FDA to clarify clinical decision support software. And, we asked them to improve the regulatory scheme overall. A lot of the regulations--quality system, pre-market, post-market requirements--were all written with physical widgets in mind, not standalone software. There's a lot of ambiguities that exist in trying to take these regulations and apply them to standalone software.

That's the set of recommendations that are most relevant to mobile health. We also had a set of recommendations that are relevant to all HIT, because remember HIT was the scope of our work. We recommended that, generally speaking, HIT not be subjected to pre-market approval or pre-market clearance by FDA, which leaves open the door that it might be subjected to things like adverse event reporting and other requirements that FDA has.

Editor's note: This intevriew has been condensed and edited for clarity.