GAO: FDA's device review too slack

Last week, FDA scientists complained to President-elect Obama about less-than-rigorous oversight at the agency, especially for medical devices. Now, the Government Accountability Office is saying that hundreds of devices got the FDA nod without a full-scale review. Some of the gadgets have since been recalled, including an external defibrillator for treating heart attack victims, Public Citizen said.

"GAO's investigation confirms my concerns that the approval process for medical devices is woefully inadequate," Rep. Frank Pallone, who heads the House Energy and Commerce Committee's health panel, told the Associated Press. "For years, Congress has required high-risk medical devices to undergo stringent premarket review, but GAO's findings show that is simply not happening in every case."

According to the AP, the agency appears to have slacked off in complying with a change in the law governing device approvals. Congress ordered the FDA to put certain devices through the wringer before letting them onto the market, but the GAO review found that many devices didn't get that close scrutiny. "[I]t is imperative that FDA take immediate steps" to fix the problem, the GAO report states.

As you know, it's not the first time GAO has scolded the FDA for failing to implement its own improvement plans, failing to properly oversee foreign drug plants, and failing to pick up on safety issues. Each time, the New York Times points out, the chastised agency pledged to do better. This time, though, the renegade scientists are backing up FDA's critics, going so far as to claim that the entire review process has been corrupted.

What's next? Pallone says he intends to convene hearings on the device issue. And next week, the guard will change at FDA. But there's no telling how long it will take to whip the embattled agency back into shape.

- read the NYT story
- see the AP coverage in the Los Angeles Times

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