Pressure Building to Revamp FDA Medical Device Approval Process

Democratic lawmakers in congress are pushing to give the FDA new authority to reject proposed medical devices, as a number of prominent consumer groups are pushing for the abolishment of the FDA’s controversial fast track medical device approval program. 

Concern and consternation continues to rise over the FDA’s 510(k) fast-track medical device approval process, which only requires that a new medical device be substantially equivalent to an existing device before being sold to, or implanted in, U.S. citizens.

Even though the program was supposed to be limited to non-critical devices, medical device manufacturers have used the program to approve things as crucial as internal defibrillators and coronary stents, allowing them to market the devices without conducting any rigorous pre-market studies to determine the products are safe or effective.

Last month U.S. representatives Henry Waxman, Edward Markey and Jan Schakowsky introduced a new bill called the Safety Of Untested and New Devices Act (SOUND), which would give the FDA the ability to deny approval to medical device manufacturers using the 510(k) program even if the device meets the substantial equivalency requirement.

Consumers Union, the advocacy arm of the watchdog Consumer Reports, is the latest group pushing for the program to be scrapped altogether, saying that too many high-risk medical devices have been approved for the market without undergoing strenuous testing.

In a letter sent to Consumer Reports subscribers earlier this year, Consumer Reports President Jim Guest pointed out that most of the 700 medical devices recalled annually were approved through the 510(k) process, including metal-on-metal hip implants.

“The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you,” Guest wrote. “This isn’t science fiction.”

Late last month, another consumer group, Public Citizen, released a study called “Substantially Unsafe”, which highlighted a lobbying push by medical device manufacturers to keep FDA oversight weak and ineffective. According to the consumer advocacy group, medical device manufacturers have given $19.9 million in campaign contributions to federal candidates since the 2006 election cycle, with lawmakers who introduced legislation to weaken federal medical regulations receiving three times as much as other candidates.

More than 200.000 injuries and malfunctions, and 2,000 deaths linked to medical devices are reported to the FDA each year, according to Public Citizen.