A Crisis in the Medical Device Industry
Hello. I am Dr. Roger Steinert, Professor and Chair of Ophthalmology at the Gavin Herbert Eye Institute, University of California, Irvine. It is my pleasure to continue the monthly blog for Medscape.
What I would like to do this month is a pre-election blog -- not to advocate for a particular candidate or a particular party, but rather to point out some things that I think we have to take responsibility to address. One way we can take responsibility is through the electoral process, but it doesn't stop there. This also translates into our responsibility to be contributors to our political action committees of AAO (American Academy of Ophthalmology) and ASCRS (American Society of Cataract and Refractive Surgery), to become active in our state societies, and to have our patients be aware of the issues that affect them -- not ones that are completely self-serving to us, but ones that affect our ability to take good care of patients.
What really had me start down this road were several events that have brought to my attention how we are evolving, not even into Third World, but Fourth World, as far as medical technology goes. The first of these was the annual European Society of Cataract and Refractory Surgery Meeting. This year it was in Milan, and I was exposed to a wide array of technologies that we simply don't have access to, nor are we likely to have access to in the foreseeable future. When a company as large as Zeiss -- I am not just talking about the little companies with intriguing devices -- does not feel that it can invest what is necessary to bring a new intraocular lens technology into the United States because of the huge regulatory hurdles, that is not a good thing. That is a real problem. And it doesn't stop there; it permeates everywhere.
I have been dealing for a year with a patient who has the need for an artificial iris, and you can't make a lot of money off of something like that. The only one that is legally available in the United States is currently through Ophtec, based in Florida. They are struggling with the US Food and Drug Administration (FDA) process in terms of accumulating data and trying to get approval for a product that, even if it is approved, is more than 10 years behind the times. There are much more color- and design-sophisticated implants that are not even engaged in an attempt to do a very basic study. It has been a compassionate-use device that you had to get through your institutional review board (IRB) and through Ophtec. Now, because the FDA is pressuring Ophtec to stop selling these on a compassionate-use basis but to generate data that can be used for a premarket approval application, this becomes a major burden. We are running into trouble with our own university IRB because Ophtec, being a commercial entity, is then supposed to pay significant amounts of money to the IRB to get IRB approval. And that doesn't begin to account for the millions necessary to get the device through FDA approval.
Why is there this big difference? That is the question I have been asking, and I am getting different answers. One of the more common themes seems to be the way we have set things up. The FDA is not out to be difficult for our patients or difficult for us. They are responding to the way that Congress has written the laws and established the system.
To get a CE mark in Europe to sell a device, you have to prove safety and a modest amount of efficacy, because the fundamental philosophy appears to be that doctors, amazingly enough, will actually do what is right for their patients, and ultimately they will determine what is right and what is efficacious through time and experience. In the United States, however, the FDA approval process is a combination of safety and efficacy with a much more rigorous standard for proving efficacy compared with Europe or other countries. As a result, it is much more difficult and much more expensive to get a device or a pharmaceutical approved by the FDA here in the United States, which brings me around to the point I was trying to make about the electoral process.
We need to be supporting candidates who understand the crisis we are facing in the medical device industry. We have the Affordable Care Act actually increasing a massive tax on medical devices. Who ultimately pays for them? Our patients and we do, through higher costs, if they are available. In many cases, we "pay" for it by simply not having the device available at all because the company does the analysis and decides that it is not going to be cost-effective. They won't be able to sell enough, so we won't see that here.
We recently did an informal analysis by looking at an issue of the Journal of Cataract & Refractive Surgery. Half of the papers dealt with technology, but only 2 of the devices were available to US ophthalmologists. All of the others, 8 or 9, were devices that we hear about. We can go to meetings and learn about them, but we can't access them for treating our patients.
Our patients need to know that this is a problem, and we need to act both by how we vote and who we support in November. Also, as we go forward, we need to make sure that we live up to our responsibilities and support the political action committees that AAO and ASCRS have. We have to be proactive, join our state societies, support our state societies, and have our voices be heard at the state level and especially in Washington, because it is Congress that has to change the expectations for the FDA. The FDA is just doing what it has been charged to do as they interpret it. We need to make it possible for a change in that culture and in that process.
Those are my thoughts for this month. I am Roger Steinert. On behalf of Medscape, thank you for listening.
Hello. I am Dr. Roger Steinert, Professor and Chair of Ophthalmology at the Gavin Herbert Eye Institute, University of California, Irvine. It is my pleasure to continue the monthly blog for Medscape.
What I would like to do this month is a pre-election blog -- not to advocate for a particular candidate or a particular party, but rather to point out some things that I think we have to take responsibility to address. One way we can take responsibility is through the electoral process, but it doesn't stop there. This also translates into our responsibility to be contributors to our political action committees of AAO (American Academy of Ophthalmology) and ASCRS (American Society of Cataract and Refractive Surgery), to become active in our state societies, and to have our patients be aware of the issues that affect them -- not ones that are completely self-serving to us, but ones that affect our ability to take good care of patients.
What really had me start down this road were several events that have brought to my attention how we are evolving, not even into Third World, but Fourth World, as far as medical technology goes. The first of these was the annual European Society of Cataract and Refractory Surgery Meeting. This year it was in Milan, and I was exposed to a wide array of technologies that we simply don't have access to, nor are we likely to have access to in the foreseeable future. When a company as large as Zeiss -- I am not just talking about the little companies with intriguing devices -- does not feel that it can invest what is necessary to bring a new intraocular lens technology into the United States because of the huge regulatory hurdles, that is not a good thing. That is a real problem. And it doesn't stop there; it permeates everywhere.
I have been dealing for a year with a patient who has the need for an artificial iris, and you can't make a lot of money off of something like that. The only one that is legally available in the United States is currently through Ophtec, based in Florida. They are struggling with the US Food and Drug Administration (FDA) process in terms of accumulating data and trying to get approval for a product that, even if it is approved, is more than 10 years behind the times. There are much more color- and design-sophisticated implants that are not even engaged in an attempt to do a very basic study. It has been a compassionate-use device that you had to get through your institutional review board (IRB) and through Ophtec. Now, because the FDA is pressuring Ophtec to stop selling these on a compassionate-use basis but to generate data that can be used for a premarket approval application, this becomes a major burden. We are running into trouble with our own university IRB because Ophtec, being a commercial entity, is then supposed to pay significant amounts of money to the IRB to get IRB approval. And that doesn't begin to account for the millions necessary to get the device through FDA approval.
Why is there this big difference? That is the question I have been asking, and I am getting different answers. One of the more common themes seems to be the way we have set things up. The FDA is not out to be difficult for our patients or difficult for us. They are responding to the way that Congress has written the laws and established the system.
To get a CE mark in Europe to sell a device, you have to prove safety and a modest amount of efficacy, because the fundamental philosophy appears to be that doctors, amazingly enough, will actually do what is right for their patients, and ultimately they will determine what is right and what is efficacious through time and experience. In the United States, however, the FDA approval process is a combination of safety and efficacy with a much more rigorous standard for proving efficacy compared with Europe or other countries. As a result, it is much more difficult and much more expensive to get a device or a pharmaceutical approved by the FDA here in the United States, which brings me around to the point I was trying to make about the electoral process.
We need to be supporting candidates who understand the crisis we are facing in the medical device industry. We have the Affordable Care Act actually increasing a massive tax on medical devices. Who ultimately pays for them? Our patients and we do, through higher costs, if they are available. In many cases, we "pay" for it by simply not having the device available at all because the company does the analysis and decides that it is not going to be cost-effective. They won't be able to sell enough, so we won't see that here.
We recently did an informal analysis by looking at an issue of the Journal of Cataract & Refractive Surgery. Half of the papers dealt with technology, but only 2 of the devices were available to US ophthalmologists. All of the others, 8 or 9, were devices that we hear about. We can go to meetings and learn about them, but we can't access them for treating our patients.
Our patients need to know that this is a problem, and we need to act both by how we vote and who we support in November. Also, as we go forward, we need to make sure that we live up to our responsibilities and support the political action committees that AAO and ASCRS have. We have to be proactive, join our state societies, support our state societies, and have our voices be heard at the state level and especially in Washington, because it is Congress that has to change the expectations for the FDA. The FDA is just doing what it has been charged to do as they interpret it. We need to make it possible for a change in that culture and in that process.
Those are my thoughts for this month. I am Roger Steinert. On behalf of Medscape, thank you for listening.