January 16, 2009

Closer Review Needed for Medical Devices

An in-depth investigation into certain medical devices has uncovered that many have won government approval without a close scientific review.

Congress ordered the Food and Drug Administration years ago to resolve the issue, but the Government Accountability Office said in a report that during the four years between 2003-2007, the agency approved 228 medical devices without a full-scale review.

According to the consumer group Public Citizen many devices approved under the less rigorous process have been recalled because of malfunctions and other problems.

The GAO report found that two-dozen distinct types of devices approved without close scrutiny, including metal hip joints, external defibrillators, and electrodes for pacemakers.

"It all adds up to less-than-rigorous device review, and it's placing tens of thousands of Americans at risk," said Peter Lurie, deputy director of Public Citizen's health research group.

The report coincides with the announcement that the FDA's Center for Devices and Radiological Health is the subject of allegations that scientists were pressured to approve medical machinery against their professional judgment.

Last week, nine FDA scientists wrote the Obama transition team complaining that a "corrupted" review process is putting public health at risk.

"GAO's investigation confirms my concerns that the approval process for medical devices is woefully inadequate," said Rep. Frank Pallone, who heads the House Energy and Commerce Committee's health panel.

"For years, Congress has required high-risk medical devices to undergo stringent pre-market review, but GAO's findings show that is simply not happening in every case."

The GAO said the root of the problem seems to be that the FDA never fully carried out the intent of a decades-old change in the law.

Congress set up a three-tiered classification system for devices in 1976.

Notifying the FDA before going to market could clear manufacturers of low-risk devices like bandages.

However, high-risk devices like pacemakers and heart valves would have to go through tighter scrutiny, and their manufacturers were required to provide evidence of safety and effectiveness.

An exception was made for new versions of high-risk devices already selling on the market.

Manufacturers could get approval of devices by convincing the FDA that they were "substantially equivalent" to their precursors.
Congress ordered the FDA to end the practice in 1990, but it has continued even as generations of technology have come and gone.

The FDA acknowledged the problem, but has not set a timetable for resolving it.

"In general, we agree with the conclusions and recommendations," said spokeswoman Karen Riley. "We are considering legal and procedural options to accomplish this objective."


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