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Too Much: Regulation?

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SAN FRANCISCO, Calif. ( Ivanhoe Newswire) - Millions of Americans rely on the FDA to tell them which drugs and devices are safe enough for use, but some say the approval process is too strict and takes too long. Is too much regulation hurting our healthcare system?

"I went in [the hospital] barely able to walk right with no control over my bladder and bowel function," Marti Conger, told Ivanhoe

Marti Conger was on the verge of paralysis. Two degenerative discs in her spine left her in severe pain and doctors suggested spinal fusion.

"Once you have fusion, you are a permanent patient," Marti said.

So Marti did her research and found a factory just outside her own city that manufactures disc implants, but they are not FDA approved in the U.S. However, they were approved in Europe in 2005.

"I ended up going to southern England and getting a device that's made 40 miles from here," Marti said. "I was basically stripped of all financial resources."

Devices like Marti's are becoming available years earlier in other countries. The watchman, which can reduce stroke risk by 75 percent in certain heart patients, is used in more than 30 countries and has been approved in Europe since 2009. Despite a seven to five vote in favor of approval, the FDA requested another safety study. The Cypass Micro-Stent, a treatment for glaucoma, has been approved in Europe for three years but is not expected to be FDA approved for another four.

"Every day I have patients that could benefit from some of these things that we just don't have available in the united states," David Chang, M.D., a clinical professor and president of the American society of cataract & refractive surgery at the University of California, San Francisco, explained.

Doctor David Chang believes the FDA's approval system needs work.

"The process has just become overly burdensome, overly predictable, and overly time-consuming," Dr. Chang said.

In Europe, a device must be safe. In the U.S, it must be safe and effective. European approvals are handled by third parties. In the U.S it's only the FDA. But a report finds the device recall rate is similar in the U.S. and Europe, suggesting faster approvals don't necessarily compromise patient safety.

"No one wants to lower the bar in terms of safety," Dr. Chang said. "The problem is you can take that mandate a little too far, and you can go so far to one extreme that you don't approve anything."

The FDA stands by their careful, and sometimes longer, approval process for high-risk devices. In a recent report they cite 12 products approved in Europe that were later found to be dangerous or ineffective and in a written statement to us, the FDA said they are working with other countries to create a "new international forum to accelerate and expand efforts to harmonize device regulatory systems and to share best practices."

Since her overseas surgery Marti's become a patient advocate even testifying before Congress for an FDA.

"When they say they ‘assess' risk, they want us to believe it's risk to our health, and it's really risk to their bad PR," Marti said.

Too much regulation or not enough? It's a question with no easy answers. Doctor Chang said the lengthy approval process has more and more medical manufacturing companies moving abroad and marketing their products in other countries first. He also said the cost of approval is about half in Europe as it is in the U.S. Meanwhile the FDA points out U.S. patients have access to low and moderate risk devices at least as early as patients in Europe.

RESEARCH SUMMARY

BACKGROUND: The U.S. Food and Drug Administration carefully scrutinizes drugs and devices before they are deemed safe for the American public. While some say the agency is looking out for public safety, others claim the approval process for life-saving medical devices takes too long. According to one study conducted by Dr. Josh Makower from Stanford University, for low- and moderate-risk devices, the process to navigate the FDA took companies an average of three months to two years longer to be granted approval than it did for a similar approval from European regulators. For higher-risk devices, the process in the United States took five-times as long as Europe to grant approval. (SOURCE: Los Angeles Times)

NOT ENOUGH ACCESS? Some doctors and patients believe the FDA's slower approval process is denying some Americans the treatment they need. "It's frustrating for us that we see these things available in other countries, and yet the approval process in the United States is so slow that we don't have access, and our patients don't have access to these really game-changing devices," David Chang, M.D., an ophthalmologist at UCSF, told Ivanhoe. "I think the whole system has to be looked at, and I think we have to look at it with the big picture of what needs to be done to streamline the process." Dr. Chang believes having an advocate within the FDA to examine the benefits of certain devices is one potential improvement that could be implemented. He also believes working with other countries and using data that was accumulated outside of the United States could streamline the process.

MEDICINE MOVING TO OTHER COUNTRIES? Some device companies are seeking early approval in Europe because it's easier and faster. "It's just a shame to see companies now really looking outside the U.S. to bring products to market," Dr. Chang told Ivanhoe. In Europe, a device must be shown to be safe, while in the United States, it must also be shown to be effective in treating a disease or condition. Also, European approvals are handled by third parties. A study found the rate of recalls in Europe was similar to that in the United States, suggesting that faster approvals overseas are not hurting patients. (SOURCE: New York Times)

THE FDA'S STANCE: The FDA defends their approval process. In a recent report, they point to 12 products that were approved in Europe first but were later found to be dangerous or ineffective, stating: "There is no requirement in the EU that a high-risk device provide an actual treatment benefit to patients…EU can fail to predict dangerous risks and lack of effectiveness in actual use." They also point out that U.S. patients have access to low- and moderate-risk devices at least as early as patients in Europe. (SOURCE: FDA, Unsafe and Ineffective Devices Approved in the EU that were not Approved in the U.S.)

INTERVIEW

David F. Chang, MD, a Clinical professor at the University of California, San Francisco, and President of the American Society of Cataract & Refractive Surgery talks about excessive delays in the FDA approval of new drugs and devices.

Why are you so passionate about this subject?

Dr. Chang: I take care of patients every day. I do primarily cataract surgery, but I am also involved in a lot of clinical research. Some of this is done with the companies that are producing some of these new devices. There are some really exciting things out there that would do a lot to improve our patients' daily lifestyle and the quality of their lives but are just not able to get through the FDA regulatory process. Every day, I have patients that could benefit from some of these medical devices that we just do not have available to us in the United States.

How long does it take for a device to get approved in the US on average?

Dr. Chang: For an artificial lens, it used to be that it might take about 8 years. Now, it looks like it is getting closer to 12 to 14 years. If we look at the last 15 devices that were approved in ophthalmology in the United States, say in the last 5 years, unfortunately they were all approved first in Europe. Some of them were available in 10 to 20 other countries before we finally got them in the United States. We are a country that prides itself on being innovative, being cutting edge, and we have some of the best medical research being done in this country; unfortunately, the American public is often at the tail-end of the introduction of these products.

What is the difference in Europe? Why are they getting things approved faster?

Dr. Chang: Europe has a much more streamlined regulatory process. They also look very hard at safety and at efficacy, but a study was done which showed that the average approval time in Europe is about half of what it takes in the United States. The interesting thing is that there was no increase in the Class I recalls for major safety problems when you look at Europe's regulatory system compared to the United States.

Is the FDA then putting American patients at more risk by not just approving some of these things quicker?

Dr. Chang: I think we all want and need our FDA to make sure that devices and drugs, when they become available in the U.S., are safe. No one wants to lower the bar in terms of safety. We want to make sure they are efficacious. The problem is you can take that mandate a little bit too far. You can go so far to one extreme that you do not approve anything. That is one way that you would never have an adverse reaction. I think if you take regulation too far, it has the harmful effect of preventing lifesaving or life enhancing products, devices, and drugs from reaching the American public. That is the hidden cost of this system. The media might cover when a drug turns out to have an adverse problem that no one expected, but what no one will hear about are all of these other devices and drugs that are not available because it is taking so long to make sure that there is not any chance that there is a problem.

Is the FDA just scared?

Dr. Chang: I think that it is probably one factor. The people at the FDA, of course, are trying to do their job as best as they can, but they are really not focused necessarily on the big picture, on what physicians and patients need. I think they are worried about being called out later on in the media that they missed something. That creates the type of mind set that is overly cautious.

What could we do? How could we change it?

Dr. Chang: The whole regulatory system has to be looked at. I think we have to look at the big picture of what needs to be done to streamline and to facilitate the process so that beneficial drugs and devices are able to reach the public in a timely fashion. There is a lot of red tape that could be cut down, because the process has just become overly burdensome, overly unpredictable, and overly time-consuming. I think that the FDA may need a different mindset that includes looking at the downside of not having a drug or device available. If you weigh that risk and that cost against the potential for perhaps an unknown adverse response - that would be helpful. I think having someone within the FDA that is really an advocate for the company would be important. What is so difficult for companies right now is that it's not a very transparent process. Some of the decisions and some of the things that they are asked to do in a study are very arbitrary, and yet the companies are not really in a position to complain about or to criticize these decisions, because these are the same people that ultimately control whether your device will get through or not. Companies would be concerned about repercussions. The fact is that it is not a very transparent process and there is really no place where companies can appeal when they feel that some of the regulatory requirements are excessively burdensome.

Do you also think though, it is because like in Europe, a lot of other countries don't file many malpractice lawsuits?

Dr. Chang: I do not think that legal liability is the primary thing. I think that, it is the regulatory process that should be revisited.

Can you give me some examples of some therapies or devices or things that are approved in Europe that you would love to see here immediately?

Dr. Chang: One of the things we deal with a lot is the artificial lens implant. 3.3 million eyes last year in the United States alone had cataract surgery, where we take out the natural clouded lens and replace it with an artificial lens. There are a whole host of lenses that can actually focus almost like the human lens when it was young. We have one type of lens where we can adjust it after it is implanted to change the prescription, so that people can really see well without glasses. This technology has been around for some time. It is approved in Europe and we do not have it here. It is lifestyle enhancing. The worst thing that would happen if it did not work in every patient is that the person just wears glasses, which is what they are doing now after surgery. We have another device that can lower the eye pressure in patients that have glaucoma but that we can use at the same time that we are already in the eye doing cataract surgery. This again has been approved in Europe and we would love to have that in the US. These are 2 examples in my field where I see patients every day that would really benefit from access to these devices.

Have you ever gone overseas to perform surgery that you cannot do here?

Dr. Chang: It is really not practical for us to go abroad to do surgery just because the device is available there. We have to be licensed there. There have been situations where patients might have to go, say to Canada to get a procedure. One type of procedure, called collagen crosslinking is very effective for people that have certain abnormalities in their cornea. This is extensively performed throughout Europe and Canada where

iIt is almost standard practice for these conditions. It is not available in the United States.

What is the most extreme thing that you have had to have a patient do to get something that they need?

Dr. Chang: There are certain types of injuries sometimes where people have their iris damaged and sometimes that patient has to go outside the United States to get an artificial iris implant to block out the excessive glare and light resulting from the missing iris. This is a problem that is just not common enough for any company to invest millions and millions of dollars to go through the FDA approval process. I do not know that we will ever have that type of product available in the United States.

Is it a lot cheaper for companies to get things approved as well in other countries?

Dr. Chang: in Europe, the cost of approval is probably half of what it is in the United States. This is another problem because so many of the medical device companies now are deciding that they may just introduce the product in Europe, and maybe not even bother bringing it to the United States because at some point it does not make economic sense. This is really hurting not just our patients in terms of the types of devices that are available, but just think about the companies, the jobs, and all of the innovation infrastructure that we could be supporting here. This is one area where the U.S. has had the best universities and research programs and it is just a shame to see more companies looking outside the U.S. to bring new products to market.

If nothing changes, what will healthcare look like in 10 to 20 years here in America?

Dr. Chang: I hope that we are not lagging way behind other regions, such as Europe in regards to the medical devices that we are able to provide. Our overly burdensome regulatory process is a big obstacle for innovators and for companies that want to be on the cutting edge by developing new products. I hope that this system does not dis-incentivize and discourage them from continuing to make major advances in healthcare.

You are talking about innovators, would the FDA's innovation pathway help this and what is it and could it be a solution?

Dr. Chang: I think that virtually everything going through the FDA is some type of innovation and I think they are certainly looking at ways to try to facilitate the approval of certain technologies. But, I think the most important thing is it's going to take a different mindset that says - let's try to make the process transparent, let's make it less arbitrary and let's remove some of the most burdensome obstacles while still making sure that the products we approve are safe.

Do we just have to throw out the rule books and start all over and rewrite everything and basically clean house at the FDA to get any change?

Dr. Chang: I do not think that the whole process has to be torn down. I think the FDA has a long and successful track record at keeping products and devices for American patients perfectly safe. However, I think that there are certainly ways to improve the process and this gets into the details of some of the regulatory burdens. Even having industry advocates within the FDA whose role is to facilitate the process and to remove unnecessary obstacles - I think that would be helpful.

Is it they should look more at the positive of the device or the drug rather than the way they attack it as it is 100 percent negative?

Dr. Chang: Yes I think that is a good point. Instead of just looking at what could go wrong, there should be some attention paid to what the upside is of this technology is. How many people it could impact? Is it doing something that we have no other cure for, no other treatment? Those kinds of devices, of course, deserve a higher priority.

You imagine the European being more streamlined, is there anything identifiable between their system and the FDA?

Dr. Chang: That is an excellent point. I think the other thing that could be done is to really look at the European regulatory system because it is also very stringent and there is a proven track record. We can analyze the differences in the time it took for different devices to get approved in the United States versus Europe and we can see what the outcome was of the longer approval process. What is this more costly and more time-consuming system that we have with our FDA accomplishing? Did it have a benefit in terms of catching drugs or devices that were approved in Europe that should not have been? I think if we look at this question, we may see that in fact we are really not getting much additional safety benefit from such an overly restrictive system.

FOR MORE INFORMATION, PLEASE CONTACT:

David F. Chang, MD
University of California, San Francisco
(650) 948-9123

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