FDA Closer to Funding Goals – Where is Patient Safety?

May 14th, 2012 | By | Category: FDA

Rep. Edward Markey

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
http://www.youtube.com/watch?v=8FTnsb5oGHA

Defective Devices, Destroyed Lives, March 22, 2012
http://markey.house.gov/sites/markey.house.gov/files/documents/Medical%20Devices%2C%20SOUND%20Act%20Report%203-2012.pdf

H.R. 5651
http://republicans.energycommerce.house.gov/news/PRArticle.aspx?NewsID=9506

Statement by AdvaMed Urging Reauthorization
http://www.advamed.org/MemberPortal/About/NewsRoom/NewsReleases/PR-HouseECMarkup050812.htm

Rep. Markeys Sound Devices Act- Feb 1 2012
http://markey.house.gov/press-release/markey-waxman-schakowsky-delauro-introduce-legislation-close-loophole-flawed-medical

Consumers Union on what Senate Bill doesn’t do to protect Consumer Safety
http://safepatientproject.org/posts/3132-consumers-gaining-momentum-in-the-senate-on-safety-in-medical-device-legislation-debate-congress-feeling-the-pressure

House Energy & Commerce Committee Press Release May 10 2012, Committee Unanimously Approves the FDA Reform Act
http://energycommerce.house.gov/news/PRArticle.aspx?NewsID=9519

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One Comment to “FDA Closer to Funding Goals – Where is Patient Safety?”

  1. anurse says:

    This longtime nurse finds it absolutely appalling and simply unbelievable that the Sound Devices Act was not included in the recent passage of the MDUFA. Thank you Rep. Markey for trying to inject some common sense and protection for patients into the current system. The Sound Act would have offered some protection for patients against defective medical devices. Now there is none and we continue to be left to the mercy of the pharmaceutical companies who are content to continue using us as guinea pigs for their medical device experiments. This nurse is disgusted with the amount of control that industry (and politics) exerts over our healthcare system, not for benefit of patients but mostly to benefit themselves. It makes me ill to think of all of the patients harmed permanently, lives completely destroyed, by widespread defective implanted medical devices such as surgical mesh, metal on metal hip replacements, pain pumps, defibrillators, angioplasty balloons, and on and on. Devices on the market by the FDA’s 510(k) process usually have no pre marketing studies or post marketing followup. It is impossible to have informed consent with these products because the risks are not completely known or understood. In the case of trans-vaginal mesh, doctors have been playing “catch-up” in diagnosing and treating the complications for years now. “Vaginal erosion” has only been an insurance code for the past few years because it became necessary for a new code as the complication was seen more frequently in clinical practice. Defective implanted medical devices on the market by PMA are immune from law suits even if they are found to be defective and removed from market because of a “loophole” in the law that is exploited by the pharmaceutical companies. There is simply no accountability for companies that harm people with defective implanted medical devices.

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.