Are FDA regulations to much

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.

"I went in barely able to walk right with no control over my bladder and bowel function," explains Marti Conger.

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

"Once you have fusion, you are a permanent patient," says Conger.

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 US. They were approved in Europe in 2005.

Marti Conger
"I ended up going to Southern England and getting a device that's made 40 miles from here,” explains Conger. “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," says Dr. David Chang, MD, a Clinical professor and President of the American Society of Cataract & Refractive Surgery at the University of California, San Francisco.

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

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

In Europe, a device must be safe. In the US, it must be safe and effective. European approvals are handled by third parties. In the US, it's only the FDA.

But a report finds the device recall rate is similar in the US and Europe, suggesting faster approvals do not necessarily compromise patient safety.

"No one wants to lower the bar in terms of safety,” says Dr. Chang. “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 overhaul.

"When they say they 'assess' risk, they want us to believe its risk to our health, and it's really risk to their bad PR,” says Conger.

Too much regulation or not enough by the FDA? It's a question with no easy answers.


REPORT: MB #3480

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.)


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

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