DELAURO TO FDA: 510(k) MEDICAL DEVICE APPROVAL PROCESS UNSAFE, MUST BE REFORMED
Washington, DC – Congresswoman Rosa L. DeLauro (CT-3) Ranking Member on the Labor, Health, and Human Services Appropriations Subcommittee, called upon FDA Commissioner Margaret Hamburg to review the Institute of Medicine’s findings on the 510(k) medical device approval process and to consider integrating them into the agency’s evaluation of the process.
Congresswoman DeLauro states that the findings released today clearly show that the 510(k) process, which grants approval to a range of low, medium, and high risk medical devices is deeply flawed and must be reformed. As the IOM noted, “the 510(k) process generally is not intended to evaluate the safety and effectiveness of medical devices.” The Congresswoman also calls for the agency to better ensure a comprehensive review of all medical devices, including both pre-market and post-market surveillance.
The text of the letter is below.
July 29, 2011
Margaret Hamburg, M.D.
Commissioner
U.S. Food and Drug Administration
U.S. Department of Health and Human Services
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
Dear Commissioner Hamburg:
I write to underscore my continued concern about the Food and Drug Administration’s (FDA) medical device approval and post-market surveillance and the agency’s response to a new review of that process.
The number of Americans that are affected by the safety and effectiveness of medical devices, specifically those that are life-sustaining or intended to be permanent implants, continues to increase. More than three-quarters of a million Americans have a hip or knee replaced each year. And more than half of the top five elective inpatient procedures reimbursed by Medicare in FY2006 included the insertion or repair of a medical device – a list that included both a hip or knee replacement and the repair of a previous hip or knee replacement.
Earlier today, the Institute of Medicine (IOM) released its findings on the 510(k) clearance process. The FDA requested this IOM review in 2009, and yet – on the very day the requested report has been released— FDA officials appear to have already reached a conclusion about the value and implementation of the report and its recommendations.
I am astonished that the agency tasked with protecting the public health may have already determined that the IOM recommendations cannot be implemented. The committee’s recommendations warrant meaningful consideration by the agency and advocates for both consumers and industry. They are clearly intended to better protect the public health by ensuring that the medical devices available are safe, effective, and appropriately monitored after approval.
A series of Government Accountability Office (GAO) studies and findings over the years clearly illustrate that the 510(k) process does not optimally protect the public health and needs to be reformed. Just this year, the FDA announced a series of changes and proposed changes to the 510(k) process based on identified shortfalls of the current inadequate process. Yet, as the IOM review clearly reinforces, there are fundamental concerns with the framework of the process that must be addressed if we are to truly protect the public health by ensuring the safety and efficacy of medical devices. A comprehensive review of medical devices, including both pre-market and post-market surveillance, is needed.
The questions and recommendations posed to the agency by the IOM are critical if Congress is to use the opportunity to review the Medical Device User Fee and Modernization Act as an opportunity to make the updates that are desperately needed to ensure the safety and effectiveness of medical devices.
Again, I strongly urge you to consider the IOM findings and recommendations as the agency continues to evaluate the approval and post-market surveillance of medical devices.
Thank you for your attention to this critical public health issue. I look forward to our continued work to protect the health of Americans.
Sincerely,
ROSA L. DeLAURO
Member of Congress
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Each day I read about new actions FDA is contimplating instituting re: medical device 510k plan and other related subjects. Why don’t you bring me infront of my peers to answer first hand information regarding the worse case results of what happened to a tax paying human being. My comments and thoughts are not from anger, they are positive in nature. I believe I can contribute to resolving a problem we all are resposible for starting.
I had a hip device put into me in 2007, went through rough times, had the device removed in 2010. I have no hip and I am restricted to a wheel chair. I spent 9+ months in the hospital, underwent 12+ operations, performed by three different surgeons.God, family, great medical team work, my grandson Hayden(now 8 years old) and visits from my labrador retriever kept a spark of life in me, which helped my will to survive.
I have communicated with people suffering from my device as well as others. I try to pass some of my positive will onto them. I pray and hope I have an impact on them.
More importantly, I believe if the medical device section of the FDA were to become a separately run entity, controlled by Dr’s,nurses, a lawyer and a few lay people( per haps people that have suffered) every one equal in voting, the group reported to the President or a power high enough in order to get immrdiate attention, and an investagative body were formed and could impose fines significant in amounts or actions, we may see changes that will insure a better quality of life for all of us.
Simplifying and making the applicable rules would save tax money and be more efficient, run properly.
I can answer questions first hand, if you haven’t experienced such a tragic event how could you possibly know the real answers.
My intentions are to provide a life experience in the hope of making this system work better, and not at the costs of our lives. We are not lab rats.
I think of myself as being more important than Market Share and Financing.
Invite me to answer questions and present real life experience.
Respectfully
Howard Sadwin
Hi Howard
Here is Rosa’s Website http://delauro.house.gov/contact.cfm
Looks like Rosa is a busy lady – how have you got on with your local representative?
Earl
I wish I could get the attention of Margaret Hamburg,and Rosa l. DeLauro. Have them read my story. Most imporant hear my thoughts, on helping a system we created and now it is failing us, on improving the medical device scenarios.
i realize the government has 2 days to pay so priorities are cut budgets, save money, create more jobs, etc. However this small but important segment of our lives needs a push in the right direction and now.
Not to repeat myself, however, I think people that have problems with hip or knee devices are not stepping forward and communicating inorder to strengthen our positions. Remember there is a statute of limitation ( time limit to initiate legal action, if any) The lawyers are beginning suits in smaller courts, other lawyers and people are waiting to see what happens and how it may or maynot impact your lives.
SPEAK up, not in anger, but in a way positive imformation can be shared amongst ourselfs. We Will Win
Howard Sadwin
Hi Howard
that is not too hard to do – let’s work on it.
By the way – where do you live?
Earl
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