Researchers criticize FDA for lax oversight; agency defends its approach
WebMD News from HealthDay
By Dennis Thompson
HealthDay Reporter
MONDAY, Sept. 29, 2014 (HealthDay News) -- Every day, people receive medical implants -- artificial valves, hip replacements, surgical mesh and the like -- that may not have been rigorously tested before or after their approval by the U.S. Food and Drug Administration, two new studies contend.
The studies -- conducted by prominent nonprofit groups and published online Sept. 29 in JAMA Internal Medicine -- lay the blame for inadequate medical device testing on lax oversight by the FDA.
Manufacturers didn't submit any scientific evidence on the safety or effectiveness of 42 out of a sample of 50 new implants in their applications to the FDA, according to a review conducted by the nonprofit National Center for Health Research. The FDA cleared the implants for use in humans.
"If you are a doctor who wants to know what the scientific evidence is that this device is safe and effective, there is no publicly available evidence," said Diana Zuckerman, president of the National Center for Health Research.
The FDA also doesn't appear to rigorously pursue companies regarding required postmarket studies intended to verify the safety of medical implants following their approval, a study by the Pew Charitable Trusts reported.
The Pew researchers found that months pass before regulators and manufacturers can even agree on the parameters for these studies, and that the studies rarely result in any action beyond a change in a device's labeling.
"We know that for a lot of the studies, there are delays of six months or more in finalizing the protocol," said co-author Dr. Joshua Rising, director of medical devices for the Pew Charitable Trusts. "We need more information to understand why it's taking so long to finalize some protocols, and why progress is inadequate for so many studies."
The FDA defended its practices in a statement, saying its "approach has served the American public well by balancing the need for robust evidence to assure safety while expeditiously bringing new technologies to the patients who need them."
The National Center for Health Research study focused on new medical devices submitted to the FDA as a modified, or "substantially equivalent," version of a device already on the market.
Under federal law, these modified devices aren't required to undergo new clinical testing. But manufacturers must provide data in their applications that prove the device is substantially equivalent to the prior version, including tests regarding safety and effectiveness, Zuckerman said.
Most new implants are cleared using this process, the study authors said. Fewer than 20 devices a year are approved under the more rigorous procedure for wholly unique implants, they said.
The researchers selected a representative sample of 50 new devices cleared by the FDA between 2008 and 2012, and checked the applications to see if companies included this information.
source : Medical Implant Devices Skate Through Review Process, Studies Claim
