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Trans Aortic Valve Replacement

Today I talk with Ian Pearson, formerly a lawyer with the FDA, now with Jones Day Law Firm. We’ll be discussing the role of the FDA. Although many Americans believe the FDA is a watchdog to keep them safe, the role of the FDA begins and ends largely with medical products, not medical practice. They are mandated by Congress to evaluate new innovations, making certain the supporting is accurate and the label with indications is appropriate.

 

The practice of medicine, including who can use these new innovations, is under the purview of State Medical Boards.

 

Consumers hoping for specific outcomes from their treatment must do their own research both on the innovation and on their doctor.

 

 

Alan Pitt: Hi, this is Alan Pitt and today on Healthcare Pittstop, I wanted to talk a little bit about innovation—the use of a device called TAVR, as well as medical software. I wanted to talk a little bit about the role of the FDA, how the public should view that role, and hopefully give listeners a better understanding of the role of the FDA. First, regarding TAVR, or Transarterial Aortic Valve Replacement, this is a device I recently came across here in Phoenix. It offers an alternative to surgery. However, in conversation with those using TAVR, I found that it may not work exactly as the public expects. The FDA plays a role in innovation and safety, so for my guest today, I have Ian Pearson. He’s a former lawyer at the FDA and is now an attorney at Jones Day, a large international law firm. Welcome, Ian. Thank you for joining me.

Ian Pearson: Thanks for having me, Alan. Always happy to talk about FDA-related and healthcare-related issues.

 

AP: Oh, that’s fantastic. Can you tell me a little bit more about your time at the FDA and your background?

 

IP: Sure. So, my entire professional career as an attorney has been based in FDA regulatory law and that’s because I graduated law school in 2009 and was directly hired by the Food and Drug Administration. And at FDA, I worked in an office called the Office of the Chief Counsel. For those who don’t speak FDA or regulatory language, the Office of the Chief Counsel was sort of the main legal artery for the agency. And like the rest of FDA, it’s broken up into different teams. So there’s a drugs team, a biologics team, a tobacco team. For me in particular, I started and ended my career at FDA on the medical devices team. I was there for about eight years, until I joined Jones Day last November where I still work on FDA-related issues.

 

IP: As you can imagine, over that time I’ve seen every kind of medical device issue from every kind of angle. I’ve worked on enforcement issues, FDA warning letters, medical device recalls, and different efforts to bring the industry into regulatory compliance. I’ve drafted regulations and worked on FDA guidance documents, policy statements, press releases, that entire aspect of it. In the past few years, I really focused on FDA’s digital health initiatives. Over the last few years, FDA realized, to its credit, that the traditional systems that were in place to regulate medical devices weren’t exactly well suited for medical software and digital health products. And so they’ve been taking steps to try to design a new regulatory paradigm to oversee these types of products. I was a part of that process while at the agency, and now that’s the focus of my practice out here in private practice.

 

AP: Oh, that’s awesome. We talked a little bit previously about the FDA, and you really kind of hit on something and I kind of walked away with this idea that the FDA walks a fine line between innovation and safety. So, what is that role of the FDA? What are they trying to do there?

 

IP: Yeah, I think that’s exactly right. Depending on administrations, the FDA is a fluid organization. There’s some inertia obviously because of its size, and it doesn’t pivot particularly quickly. But if you look at FDA’s mission statements, putting aside tobacco and food for a second and just looking at medical products, drugs, devices, and biologics, there are two key elements to that mission statement. The first is protecting public health by ensuring the safety and effectiveness of those medical products. And then what a lot of people don’t realize is, there’s also a second part to that mission statement that FDA takes very seriously. The FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable.

 

IP: So, I think there’s a couple ways to think about that, and people do think about it in a few ways. One is a pendulum, where FDA’s sort of balancing safety and effectiveness versus innovation and trying not to tilt one way or the other. You tilt too far on the innovation side and potentially get products that aren’t—there’s not a reasonable assurance that safe and effective products might get out to the market. You tilt too far in the other direction and you’re stifling innovation, and then to a certain extent FDA might be failing in their mission to protect public health because innovation and medical practice will become stagnant because regulation will become so burdensome that new innovators and products won’t get out to the market.

 

AP: Yeah, that’s a tough one. You know, you’ve used this phrase when a device or drug or even software gets “into the wild,” that’s not really the place for the FDA. So I guess what I’m hearing from you is that the FDA kind of has a starting point and an end point where they’re involved with something that’s going to be used for care. Is that a fair way to look at it?

 

IP: It is in some respects. Once a product is reviewed by FDA, and when it comes to medical devices, it can be reviewed in a number of different ways because, as everyone realizes, not every type of medical product requires the same level of regulatory review. For instance, a piece of gauze or a Band-Aid doesn’t need the same type of review as a pacemaker. So the types of pre-market review can vary quite distinctly. And then the product is either cleared or approved by FDA and once it is put sort of “out in the wild,” so to speak, it has permission to be commercially distributed. FDA still has a role in the post-market context, but it’s really focusing not on practitioners, but on medical device manufacturers, for instance.

 

IP: So, the FDA is still inspecting manufacturers to ensure that the products are being manufactured in compliance with what’s called the Quality System Regulation. The FDA is reviewing to ensure that, generally, labeling lines up and marketing materials are lining up with what the product has been approved for or has been cleared to do. And then, there’s certain record-keeping requirements for manufacturers. For instance, if they’re getting reports from distributors saying, “Hey, people are being hurt by this product or its manufacturer,” or “It’s malfunctioning in some way,” those manufacturers are required to submit reports to the agency, and then the agency can take appropriate action from that point.

 

IP: On the other hand, what the agency is not doing is stepping into a practitioner–patient relationship, and this has been FDA’s long-stated position. In fact, as it relates to medical devices, it’s actually a statutory prohibition. Not to go too far into the weeds into the law, but Section 1006 of the Federal Food, Drug, and Cosmetic Acts states directly that “Nothing in this Act shall be construed to limit or interfere with the authority of a healthcare practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate healthcare practitioner–patient relationship.” FDA takes that very seriously, and so does the public. And, as you might imagine, so do physicians. So when FDA has in the past maybe have stepped too far, people were very quick to check that and refer to that, to this provision, to ensure that FDA is not stepping into the role of a doctor.

 

AP: This is super, super interesting to me. The reason I got sort of interested in this initially was that TAVR was being used throughout my city, throughout cities across the U.S., and the practitioners had a huge variety of experiences and complications. They’re all using an FDA-approved device, but the FDA really has no say in who uses that device based on their experience or outcomes. Would that be a fair statement?

 

IP: Unless there was something specifically in the labeling or the approval, if there was a particular restriction on the use of the device that demanded and said in the labeling that this device should only be used by a practitioner with a specific background or specialty, maybe there would be some kind of limitation there. But generally speaking, if the practitioner is licensed in a particular state and they’re able to practice medicine, they have a patient, and they’re making a determination to use a particular product within that legitimate practitioner–patient relationship, FDA will not be stepping into that situation, and they will have no role in that regulation.

 

AP: Yes, you know, that’s interesting to me. I think, at least some in the public—although the FDA has disclaimers about this—I think some in the public look at the FDA as a guardian of safety in some way. But what I’m hearing is, the FDA is really ensuring the safety of the device, the drug, and it’s really up to the practitioner, and to some degree, to the patient, to check on that practitioner who is using that device to make sure that they’re going to get an expected outcome, rather than the FDA being responsible in any way, shape, or form for the outcome. Would that be fair?

 

IP: Yes, I think that’s fair. FDA is looking at products, and so what people have to realize about an FDA review is a sponsor, a manufacturer, let’s say of a medical device, is coming in with a particular medical device. They’re coming in with their data that show that the device is safe and effective for the particular use that they want to promote it for. FDA is reviewing that within the confines of the data that they’re looking at, and they’re making a determination based on what’s in front of them. Once the device is approved and, as we’ve been saying, “out in the wild,” practitioners then can take a look at the same data, and can use their own medical experience to determine whether a device could be used differently or a drug can be used differently. It can benefit a patient in a different area, and FDA is not going to be a protector in that situation.

 

AP: Got it. So I guess, in terms of advice to patients and their families, if you’re going to be exposed to a really complicated device such as TAVR, which is relatively new, even though it’s FDA approved, you need to ask that particular physician, “How often do you put this in? What is your complication rate? How does your complication rate and your number of procedures stack up against other people who are using this device, perhaps regionally or even nationally?” Those would be reasonable questions for patients and families to ask, as opposed to just saying, “Oh, it’s FDA approved, we’re good to go.”

 

IP: Right.

 

AP: I wanted to ask you—I spend a lot of time in Health IT, and that is a really hot space right now in terms of how technology and healthcare interface, and a lot of the technology allows patients to self-diagnose or assists physicians with diagnosis. There must be some evolving guidelines as a lot of these newer softwares are being released into the wild to care for people, right?

 

IP: Yes, that’s one area that I focused on, that is specifically undergoing rapid changes in the regulatory landscape for digital health software-based products which is still undergoing evolution, let’s say. This is because the medical device amendments were actually enacted in the mid-1970s, and the products that were out, as we touched on, don’t really resemble the type of products that exist in the digital space, and so FDA still under those statutory provisions is attempting to try to review these software-based products under these very old statutory provisions, and it just has proven not to work out that well for anyone.

 

IP: FDA might be looking at things and reviewing them in ways that they don’t particularly need to, and for software developers that have different manufacturing, different validation, and different verification processes than traditional medical device manufacturers, might find those traditional medical device regulations to be overly burdensome. So they might be, let’s say, a little bit scared off by what they’re seeing in the medical device space. And FDA realized that, and a few years ago started issuing guidance documents that explain what the FDA’s regulatory approach will be in this area that could potentially create a little more incentive for medical device manufacturers to engage with the agency.

 

IP: We’ve also seen the enactment of new legislation in the 21st Century Cures Act at the end of 2016 that specifically excluded certain types of digital health and medical software from the purview of the Food and Drug Administration. In addition, an exciting program the FDA has been working on is something called the Software Pre-Certification Pilot Program. The goal of this program is to evaluate medical software developers differently from how FDA traditionally looked at medical device manufacturers, in that a medical software manufacturer might be able to come to FDA if the program is finalized, and get validated as a manufacturer such that they wouldn’t have to come in time and time again every time they want an update or want to add a new feature to their software.

 

AP: That would be great, yeah. Can I ask, will the FDA then want to take a software that says, “I want to diagnose people?” Does the software have to be as good as a human being who takes a history and physical examination? Do they have some sort of, using broad strokes here, do they have some sort of guidance in terms of how that software, is it supposed to augment the physician and support them? Or is it supposed to kind of compete with the physician as a diagnostician?

 

IP: Right. There are different types of diagnostic software, and this can incorporate things like artificial intelligence and machine learning. Based on what the software is designed to do, the level of FDA review might change. For instance, the 21st Century Cures Act, which I just talked about, excludes something called clinical decision support software from FDA’s regulatory jurisdiction. That type of software is diagnostic in nature, but it’s meant to supplement a physician’s own knowledge. It’s meant to help inform the physician to make a final diagnostic decision. On the other hand, if you have sort of a completely autonomous AI software for which you’re punching in some inputs and it’s spitting out a diagnosis, then that’s going to be fully reviewed the same way any kind of traditional medical device that does diagnosis is going to be reviewed. So FDA’s going to want to see data that show that this thing can predictably, reliably do what it says it does and come to the right outcomes.

 

AP: Yes. I was involved with a robotics project years ago and we built this robot, and I remember them telling me, if your finger is on the robot, then the robot is augmenting your treatment. If you’re not touching the robot, the level of regulation… It just explodes. And I would imagine, software’s kind of similar. If I’m supporting the physician to make a final decision as opposed to an autonomous software. Very, very different.

 

IP: Absolutely.

 

AP: Yeah. So, Ian, I want to summarize what we talked about. So I guess what I’m hearing from you is, the FDA really has this balance between safety and innovation and that they struggle with. Even if the product is being used as expected, it’s really up to the public to define that the practitioner has the qualifications, and has the experience to use the device. We as the public can’t use the FDA as a safety net, if you will; as a mechanism to ensure a good outcome, and that we all have to be active participants in our own care.

 

IP: Yes, I think you can view FDA as a partial safety net as it relates to the product, but it’s certainly not going to cover every aspect of your healthcare. And that’s by design; that’s the provision that I read about, the practice of medicine, and I think it was determined long ago that we didn’t want a federal agency stepping into that relationship. So it really becomes incumbent on patients to take some control of their own healthcare. If you’re being prescribed a particular drug or medical device, ask questions of your physician. If you don’t understand what a particular adverse event might mean for your life to really get into the weeds, get into the details with them, to find a physician you trust.

 

IP: If you’re very ambitious, there is information on FDA’s website that’s posted about particular clearances, approvals of medical products, that will give you a summary of what FDA looked at and what the particular diseases and conditions a particular product is meant to treat or diagnose. All that to say, I don’t think any one piece of this information is going to be the entire puzzle, but it’s all different things that you can look at and put together to help yourself come to a conclusion about how you want your healthcare to look.

 

AP: Yes. I struggle as a physician because I see that the financial incentives for hospitals and physicians are often not aligned with the highest quality outcomes. In some ways, I was hoping the FDA was that protector, but I understand why they’re not, and we kind of have to step up as individuals to participate in that. So, super interesting. Ian, for those interested in getting FDA approval for device or drugs, or software, I guess they can contact you at Jones Day, and I’ll post your email on the podcast. I really appreciate your time. Thank you very much.

 

IP: Yes. Thanks for having me.

 

Mr. Pearson can be reached at ipearson@jonesday.com