FDA Closer to Funding Goals – Where is Patient Safety?

Jane Akre
May 15, 2012

On May Tuesday, May 8, a House subcommittee unanimously voted to approve its version of the Medical Device User Fee Act (MDUFA) which funds the U.S. Food and Drug Administration’s oversight of medical devices for the next five years.

However, the House voted 46-0 without approving legislation that would protect Americans from defective medical devices such as surgical mesh, metal-on-metal hips and defibrillator leads.

In February, Rep. Edward Markey introduced H.R. 3847 the Safety Of Untested and New Devices, Sound Devices Act that would give the FDA the authority to put the brakes on the approval of a medical device that names as its “substantial equivalent” an earlier device that’s been found to be defective or has been recalled. The authority was also championed by Consumers Union and its Safe Patient Project.

Rep. Markey lets his fellow lawmakers know he was disappointed the Sound Devices Act was not included in the passage.

16:31 “I regret that the majority was unwilling to any part of the legislation I introduced with Mr. Waxman and Ms. Schakowsky to ensure that the FDA has the ability to reject devices if they are modeled after defective devices that have been recalled from the market. The safety of untested and new devices act would have required FDA to reject new application as we heard from the bill’s opponents, but rather it would have given the FDA the authority to reject if the company could not show that the new device avoided serious previous flaws. Unfortunately, now the FDA is legally obligated to clear a new medical device if shows similar to an earlier model even if that model was recalled for serious safety problems.”

Rep. Markey entered into the record a report on the issue created by his staff, “Defective Devices, Destroyed Lives: Loophole Leaves Patients Unprotected from Flawed Medical Devices,” that highlights the 510(k) process which some consider a loophole that allows a defective' predicate' to be named as the basis for the approval of a new device.

The legislation refers to the recalled ProteGen mesh, used as a predicate device for almost every synthetic surgical mesh on the market today despite the fact that Boston Scientific’s ProteGen was recalled for safety concerns in 1999.

Currently the FDA does not have the authority to stop the approval of a medical device that names as its ‘predicate’ one that has already been recalled from the market. Over 90 percent of medical devices are fast tracked into the marketplace though the predicate system known as 510(k), which bypasses any requirements for safety and efficacy. It is a green light to market not a reassurance of medical device safety.

The medical device industry has said it is unnecessary to change the FDA’s approval process.

MDUFA, provides about one-third of the FDA’s budget including the hiring of experts and scientists to review medical device applications.

Industry has agreed it will commit about $595 million in medical device user fees almost doubling the budget from the last five years. However industry wants tighter approval times and less stringent rules and quicker medical device approvals in return.

But Consumers Union found the public had a different idea about priorities. CU cited its recent poll that 82 percent of respondents said preventing safety problems is a more important issue for the FDA than encouraging innovation by limiting safety testing on devices. And 91 percent of respondents believed that each medical implant should be safety tested even when they are the substantial equivalent to another already on the market.

The MDUFA and PDUFA (prescription drug user fee act) approvals are part of the Food and Drug Administration Reform Act H.R. 5651. It now moves on to the full House and Senate for approval and onto the president for his signature likely to happen before the summer recess. #

Learn More:

Rep. Markey on YouTube


Defective Devices, Destroyed Lives, March 22, 2012


H.R. 5651


Statement by AdvaMed Urging Reauthorization


Rep. Markeys Sound Devices Act- Feb 1 2012


Consumers Union on what Senate Bill doesn’t do to protect Consumer Safety


House Energy & Commerce Committee Press Release May 10 2012, Committee Unanimously Approves the FDA Reform Act


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