FDA approval process faulted at hearings on medical devices

By Matthew Perrone
Monday, February 21, 2011; 6:57 PM

The Food and Drug Administration is approving medical devices too slowly. Or too quickly - depending on whom you ask.

House lawmakers heard both arguments Thursday at a hearing examining the FDA's regulation of U.S. medical devices, a $120 billion industry that includes hospital beds and heart pumps.

FDA leadership is in the process of overhauling the 35-year-old system used to clear most devices, triggering a slew of reports and analyses aimed at influencing the agency's plans.

On the one side are device manufacturers, who say that FDA reviews have gotten longer and less predictable, forcing some companies to launch their devices overseas to stay in business. They say American patients no longer have access to the latest medical treatments, forcing some to fly to Europe for surgery.

But consumer safety advocates say that the FDA is clearing too many devices too quickly, jeopardizing patient safety.

Can both be right?

"Not unless we're in an episode of 'Star Trek' with parallel universes," FDA device director Jeffrey Shuren said in a recent interview with the Associated Press.

Shuren said the U.S. system is not inherently slower than Europe's, though it requires an extra level of evidence. European regulators require that a device be safe and perform as described on its label. The FDA has those standards but also requires that the device be proven to successfully treat a disease. Shuren points to a handful of devices that were rejected by the FDA and approved in Europe, only to be recalled for safety reasons.

"Just because a technology is available in another country doesn't mean it works or even that it's necessarily safe," he said.

The main problem the FDA has encountered in recent years, according to Shuren, is the declining quality of applications from device makers. He said that more than 50 percent of applications for conventional medical devices miss key information, leading to delays that should have been avoided.

"We're stepping up to the plate to do our part to get this right. But if it's going to work, we need industry to do their part," Shuren told members of the House Energy and Commerce health subcommittee.

Seated with Shuren at the witness table was a trio of device industry entrepreneurs, who said the pace and unpredictability of FDA reviews is driving some companies into bankruptcy.

"Investment is drying up, companies are moving overseas or closing their doors, and U.S. patients are being denied timely access to safe and effective new medical products," said Josh Makower, a medical device inventor and consulting professor at Stanford University.

Makower and the others pointed out that venture capital, which is critical to start-up companies, has dropped 37 percent across the device sector since 2007. Although some of that decline is unquestionably due to the recession, entrepreneurs insist the FDA's regulatory stance is also to blame.

Makower hammered home a key argument of device companies: It typically takes them two years longer to get devices approved in the United States than in Europe.

That figure and others are from a survey sent to 750 device companies; only 17 percent responded. PricewaterhouseCoopers released a similar report last month, and its conclusions relied on a survey of 13 companies.

A committee room mostly filled with Republicans concentrated their questions on the FDA device director and industry representatives.

Patient-safety advocates present at the hearing said U.S. device approvals are often too fast.

Steven Nissen reiterated data from a study published this month suggesting that the FDA is clearing too many devices through a fast-track pathway designed for low-risk devices.

The analysis found that 70 percent of life-threatening recalls between 2005 and 2009 involved devices cleared through the fast-track method, rather than a more rigorous system that requires medical testing.

"There's a serious problem here when 112 million devices were recalled in less than five years," said Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic.

Devices cleared through the fast-track, or 510k, method, are often approved within 90 days, provided they are similar to devices already on the market. Devices requiring "pre-market review" usually need human testing, which takes years and tens of millions of dollars.

But the FDA has questioned the significance of the numbers because the devices recalled represent about 1 percent of those approved via 510k. Also, because the agency approves 90 percent of its devices through the fast-track program, it is expected that more of those devices would be recalled.

- Associated Press

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