FDA device regulator faces critics from both sides

February 17, 2011 By MATTHEW PERRONE , AP Health Writer

(AP) -- 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 of U.S. medical devices, a $120-billion industry that includes everything from hospital beds to heart pumps.

FDA leadership are 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 charge 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 say just the opposite: FDA is clearing too many devices, too quickly, jeopardizing .

Can they both be right?

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

Shuren said the U.S. system is not inherently slower than Europe's, though it does require 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 later 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. According to Shuren, more than 50 percent of applications for conventional are missing 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 Committee's Health Subcommittee.

Seated with Shuren at the witness table was a trio of device industry entrepreneurs, who argued that 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 Dr. 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. While 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: that it typically takes companies two years longer to get devices approved in the U.S. than in Europe.

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

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

Patient safety advocates were also present at the hearing to argue that U.S. device approvals are often too fast.

Dr. Steven Nissen reiterated data from a study published last week suggesting 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 cardiovascular medicine at the Cleveland Clinic.

Devices approved 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 require human testing that takes years and tens of millions of dollars.

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

Explore further: FDA medical device approvals get external review


Related Stories

FDA medical device approvals get external review

September 23, 2009

(AP) -- The Food and Drug Administration is asking the government's top medical advisers to review its system for approving certain types of medical devices, which has been criticized by safety advocates and government watchdogs.

FDA stepping up oversight of drug pumps

April 23, 2010

(AP) -- Federal health regulators on Friday announced steps to improve the design and safety of drug pumps that have been linked to more than 700 deaths in the past five years.

FDA moves toward tighter medical device oversight

August 4, 2010

(AP) -- Makers of X-ray machines, drug pumps and other medical devices would have to submit more safety information to win federal approval under a proposal designed to tighten regulation of thousands of products reviewed ...

FDA plans modest changes to medical device system

January 19, 2011

(AP) -- The Food and Drug Administration is laying out plans to update the 35-year-old system used to approve most medical devices, which has been subject to increasing criticism by public safety advocates.

FDA aims to accelerate medical device reviews

February 8, 2011

(AP) -- Federal health officials have proposed a plan that would speed up the approval of innovative medical devices that hold the potential to dramatically improve patients' lives.

Recommended for you

How the finch changes its tune

August 3, 2015

Like top musicians, songbirds train from a young age to weed out errors and trim variability from their songs, ultimately becoming consistent and reliable performers. But as with human musicians, even the best are not machines. ...

Machine Translates Thoughts into Speech in Real Time

December 21, 2009

(PhysOrg.com) -- By implanting an electrode into the brain of a person with locked-in syndrome, scientists have demonstrated how to wirelessly transmit neural signals to a speech synthesizer. The "thought-to-speech" process ...


Adjust slider to filter visible comments by rank

Display comments: newest first

not rated yet Feb 23, 2011
I bet the "consumer safety advocates" are all from corporations which are trying to impede competition thereby protecting profits for their medical devices already on the market.
not rated yet Apr 15, 2011
I find it very disconcerting that such little pressure is placed medical device manufacturers to prove the quality of the product. The FDA, the supposed watchdog of the American publics health, has succumbed to the pressure of these powerful corporations. I have found a really good compiling of recalled devices at medicaldevicerecall.com, for anyone that feels they may have received a recalled device and would like more information about what devices are subject recall.

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.