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 health care system?
"I went in [the hospital] barely able to walk right with no control over my bladder and bowel function," said Marti Conger.
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. 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 7 to 5 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," explained David Chang, M.D., a clinical professor and president of the American society of cataract & refractive surgery at the University of California, San Francisco.
Chang believes the FDA's approval system needs work.
"The process has just become overly burdensome, overly predictable, and overly time-consuming," 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," 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 says the lengthy approval process has more and more medical manufacturing companies moving abroad and marketing their products in other countries first. He also says 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.
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.