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Mr. Epstein speaks out in Forbes against Medical Device Preemption AND repeal of Drug Preemption. Mr. Epstein is one of the leading proponents of FDA Preemption.
It is time to examine the arguments of this fine lawyer and see if his words hold water.
Please take a look at the link and let us know what you think.
Showing posts with label Medical Device Preemption. Show all posts
Showing posts with label Medical Device Preemption. Show all posts
Tuesday, August 11, 2009
Saturday, June 20, 2009
GAO Has an Opinion of the FDA - Not Good
Add one more in the long line of respected authorities to raise the flag of danger about the FDA's capability to protect the American public.
The Government Accountability Office (GAO) has completed a study of the effectiveness of the FDA and in testimony before Congress concluded.
The highlights to the report to Congress from the GAO can be found here
The full report to Congress can be found here.
The Government Accountability Office (GAO) has completed a study of the effectiveness of the FDA and in testimony before Congress concluded.
"...these shortcomings in both premarket and postmarket activities raise serious
concerns about FDA's regulation of medical devices."
The highlights to the report to Congress from the GAO can be found here
The full report to Congress can be found here.
Monday, May 11, 2009
Scare Tactics and Presumptions Continue as Congress Debates Medical Device Safety
As time approaches for Congress to protect our civil rights we see another misguided article intended to scare Congressional decision makers into believing that ending the 2 year old policy of FDA Preemption will destroy the inventiveness of the Pharmaceutical industry.
Shame on them for presuming (or at least presenting the position) that our Pharmaceutical Industry is not capable of making both effective and safe products.
Here again is the article in full to be examined for its falsity. Please also note the source -
Patients Call for Continued FDA Preemption Authority
FDA Best Positioned to Review Medical Technology
WASHINGTON, May 11 /PRNewswire-USNewswire/ -- Patients from across the country came to Washington, D.C., to share their stories about how medical technology has helped improve or save their lives in advance of a May 12 U.S. House of Representatives Energy & Commerce Committee hearing on the Medical Device Safety Act of 2009, legislation to repeal the Food and Drug Administration's (FDA) preemption authority.
"Without my medical device, I would not be here today," said Laura Doud of Arlington, Virginia, who received life-saving implantation of cardiac resynchronization therapy with defibrillation in 2004 after suffering almost fatal viral cardiomyopathy. "If the proposed legislation were passed, would the lawsuits facing inventors and manufacturers prevent devices like mine or future medical innovations from ever making it to patients like me?"
"Every day millions of patients' lives are saved or enhanced thanks to innovative and safe medical technology," said Stephen J. Ubl, president and CEO of AdvaMed. "Unfortunately, you are not likely to hear these patients' stories in tomorrow's hearing."
Ubl added, "The Supreme Court's 8-1 decision in Riegel v. Medtronic foreshadowed what we will see in courtrooms and what we will see in the hearing tomorrow -- that the thousands of patients who have benefited from these technologies will not be considered."
The 8-1 majority Supreme Court decision asks, "How many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court."
Patients came to Washington from across the country to explain the importance of medical devices in saving and enhancing their lives, and to speak out about protecting access to devices now and in the future. In addition to Laura Doud, medical device beneficiaries who attended the briefing include:
Adam Hammond, from Columbus, Ohio, a former U.S. Army Officer and Golden Knights parachutist who suffered life-threatening injuries when his parachute failed to open. He can now walk and function again without severe and debilitating chronic pain after receiving a neurostimulator.
Tom Price, a long-distance runner from Syracuse, New York, was unable to run more than a mile due to calcification and severe regurgitation in his bicuspid aortic valve. After aortic valve replacement, he has resumed his active lifestyle.
Mike Roman, from St. Louis, Missouri, a world-class race car driver who received a spinal cord stimulator to treat the constant, debilitating pain he felt after losing his leg to infection.
Olivia Vervaeke, a senior from Detroit, Michigan, graduating this week from the University of Notre Dame, born with a congenital heart defect that severely worsened in high school. Olivia required an implantable cardioverter defibrillator (ICD) in 2005.
The patients emphasized how critical it was for them to have access to devices when they needed them most.
"This device saved my life," said Olivia Vervaeke, who is graduating from college on Sunday, May 17 but took a break from wrapping up her final days at Notre Dame to come to Washington to tell her story. "I can run five miles a day now; I could never do that before."
"We should be working to strengthen FDA resources so more medical devices can be made and improved -- not make it more difficult for patients to access them," said Tom Price, who has run multiple half- and full-marathons less than two years after his aortic valve replacement surgery.
"I tried medicine, surgeries and even older technology without success. Thanks to continued research and innovation, I was able to receive a spinal cord stimulator that finally relieved my pain," said Roman, who uses his professional racing efforts to inform chronic pain sufferers that there is hope and they are not alone. "We need to preserve innovations for others like me."
Patients also expressed concern about turning the review of their complex medical devices, which can often take years of scientific and regulatory oversight, over to states and courtrooms that lack the necessary expertise and budgets.
"How does a lawyer or a judge or a jury know more than my doctor, the FDA or the engineers who invented and developed the medical device that gave me back my life?" said Adam Hammond, who is the first person in the world to be implanted with an Eon Mini neurostimulator.
"This legislation does not in any way improve patient safety," concluded Mr. Ubl. "It will only restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans. We can't let that happen."
The patients will remain in Washington for tomorrow's hearing and meet with their members of Congress about the importance of protecting access to safe and effective medical devices.
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit http://www.advamed.org/.
SOURCE AdvaMed
Shame on them for presuming (or at least presenting the position) that our Pharmaceutical Industry is not capable of making both effective and safe products.
Here again is the article in full to be examined for its falsity. Please also note the source -
Patients Call for Continued FDA Preemption Authority
FDA Best Positioned to Review Medical Technology
WASHINGTON, May 11 /PRNewswire-USNewswire/ -- Patients from across the country came to Washington, D.C., to share their stories about how medical technology has helped improve or save their lives in advance of a May 12 U.S. House of Representatives Energy & Commerce Committee hearing on the Medical Device Safety Act of 2009, legislation to repeal the Food and Drug Administration's (FDA) preemption authority.
"Without my medical device, I would not be here today," said Laura Doud of Arlington, Virginia, who received life-saving implantation of cardiac resynchronization therapy with defibrillation in 2004 after suffering almost fatal viral cardiomyopathy. "If the proposed legislation were passed, would the lawsuits facing inventors and manufacturers prevent devices like mine or future medical innovations from ever making it to patients like me?"
"Every day millions of patients' lives are saved or enhanced thanks to innovative and safe medical technology," said Stephen J. Ubl, president and CEO of AdvaMed. "Unfortunately, you are not likely to hear these patients' stories in tomorrow's hearing."
Ubl added, "The Supreme Court's 8-1 decision in Riegel v. Medtronic foreshadowed what we will see in courtrooms and what we will see in the hearing tomorrow -- that the thousands of patients who have benefited from these technologies will not be considered."
The 8-1 majority Supreme Court decision asks, "How many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court."
Patients came to Washington from across the country to explain the importance of medical devices in saving and enhancing their lives, and to speak out about protecting access to devices now and in the future. In addition to Laura Doud, medical device beneficiaries who attended the briefing include:
Adam Hammond, from Columbus, Ohio, a former U.S. Army Officer and Golden Knights parachutist who suffered life-threatening injuries when his parachute failed to open. He can now walk and function again without severe and debilitating chronic pain after receiving a neurostimulator.
Tom Price, a long-distance runner from Syracuse, New York, was unable to run more than a mile due to calcification and severe regurgitation in his bicuspid aortic valve. After aortic valve replacement, he has resumed his active lifestyle.
Mike Roman, from St. Louis, Missouri, a world-class race car driver who received a spinal cord stimulator to treat the constant, debilitating pain he felt after losing his leg to infection.
Olivia Vervaeke, a senior from Detroit, Michigan, graduating this week from the University of Notre Dame, born with a congenital heart defect that severely worsened in high school. Olivia required an implantable cardioverter defibrillator (ICD) in 2005.
The patients emphasized how critical it was for them to have access to devices when they needed them most.
"This device saved my life," said Olivia Vervaeke, who is graduating from college on Sunday, May 17 but took a break from wrapping up her final days at Notre Dame to come to Washington to tell her story. "I can run five miles a day now; I could never do that before."
"We should be working to strengthen FDA resources so more medical devices can be made and improved -- not make it more difficult for patients to access them," said Tom Price, who has run multiple half- and full-marathons less than two years after his aortic valve replacement surgery.
"I tried medicine, surgeries and even older technology without success. Thanks to continued research and innovation, I was able to receive a spinal cord stimulator that finally relieved my pain," said Roman, who uses his professional racing efforts to inform chronic pain sufferers that there is hope and they are not alone. "We need to preserve innovations for others like me."
Patients also expressed concern about turning the review of their complex medical devices, which can often take years of scientific and regulatory oversight, over to states and courtrooms that lack the necessary expertise and budgets.
"How does a lawyer or a judge or a jury know more than my doctor, the FDA or the engineers who invented and developed the medical device that gave me back my life?" said Adam Hammond, who is the first person in the world to be implanted with an Eon Mini neurostimulator.
"This legislation does not in any way improve patient safety," concluded Mr. Ubl. "It will only restrict patient access to essential medical technologies, produce a chilling effect on medical innovation, create more lawsuits and ultimately result in higher health care costs for all Americans. We can't let that happen."
The patients will remain in Washington for tomorrow's hearing and meet with their members of Congress about the importance of protecting access to safe and effective medical devices.
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Our members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit http://www.advamed.org/.
SOURCE AdvaMed
Wednesday, May 6, 2009
STUDY ON MEDICAL DEVICE PREEMPTION - Your Thoughts?
Title Revision 2
I will go ahead and copy the report on this study word for word as I think it is important to see.
Your thoughts on this are appreciated.
Removing Medical Device Preemption Impacts Jobs, Health Care Costs, Patient Access
BOSTON, May 6 /PRNewswire-USNewswire/ -- In a white paper released today by Ernst Berndt and Mark Trusheim of the Massachusetts Institute of Technology, research shows that eliminating FDA's preemption protection would decrease patients' access to life-enhancing medical devices, increase health care costs and reduce medical device industry employment.
The paper, "The Economic Impact of Eliminating Federal Preemption for Medical Devices on Patients, Innovation and Jobs," comes as Congress considers legislation that would remove Federal preemption of state rules and litigation that exists for a small percentage of medical devices that undergoes the most rigorous FDA review. The report highlights the damaging economic, health and societal impacts the legislation would have on patients, medical device industry innovation and employees, and the public health.
"As economic and health care researchers, we felt it was important to examine how this regulatory change could harm innovation, and ultimately impact the patients who rely on these treatments and the people who are employed by the device industry" said co-author Ernst Berndt, Ph.D., Louis E. Seley Professor in Applied Economics, MIT Sloan School of Management. "Congress should carefully weigh any policies that could increase health care costs and reduce high-paying jobs, particularly during an economic downturn."
The authors' research highlights the consequences to multiple stakeholders - patients and the public health, medical device inventors and manufacturers, their employees and the government - if medical device preemption were eliminated. For example,
Patients' access to medical devices and the benefits they provide would be reduced; as prices increase, products may be withdrawn, and fewer new products will be developed.
Physicians will increasingly practice defensive medicine to avoid litigation and expose patients to added risks of otherwise unnecessary procedures.
For those employed by the medical device industry, the increased manufacturers' costs would discourage investment in medical device development, reducing the R&D pipeline of innovative new products created and brought to market, and lead to layoffs of high-paying jobs.
Medical innovation would be affected, as decisions about health care products shift from expert, science-based regulators to untrained, non-expert juries, creating a duplicative, fragmented and inconsistent national framework administered by state and federal courts.
The government would experience increased costs, as Medicare and Medicaid spend more than they otherwise would due to fewer new product innovations, and government pays for increasing judicial system, tort and duplicative state regulatory costs.
"The question is not whether eliminating preemption will reduce innovation, but rather by how much and how rapidly," said co-author Mark Trusheim, Visiting Scientist at the MIT Sloan School of Management. "High levels of tort risk discourage investment in new technology. Eliminating preemption substantially alters the benefit/risk ratio of complex medical devices, increases the costs for all stakeholders, and negatively affects patients' future access to treatment options."
"Given these findings, and current economic circumstances, Congress should carefully consider any change to current law as the ramifications could substantially harm patient choice and health," Trusheim concluded.
The report was made possible by a grant from the Advanced Medical Technology Association. The views expressed are those of the authors only, and do not necessarily reflect views of the sponsor or MIT.
SOURCE Berndt Associates
I will go ahead and copy the report on this study word for word as I think it is important to see.
Your thoughts on this are appreciated.
Removing Medical Device Preemption Impacts Jobs, Health Care Costs, Patient Access
BOSTON, May 6 /PRNewswire-USNewswire/ -- In a white paper released today by Ernst Berndt and Mark Trusheim of the Massachusetts Institute of Technology, research shows that eliminating FDA's preemption protection would decrease patients' access to life-enhancing medical devices, increase health care costs and reduce medical device industry employment.
The paper, "The Economic Impact of Eliminating Federal Preemption for Medical Devices on Patients, Innovation and Jobs," comes as Congress considers legislation that would remove Federal preemption of state rules and litigation that exists for a small percentage of medical devices that undergoes the most rigorous FDA review. The report highlights the damaging economic, health and societal impacts the legislation would have on patients, medical device industry innovation and employees, and the public health.
"As economic and health care researchers, we felt it was important to examine how this regulatory change could harm innovation, and ultimately impact the patients who rely on these treatments and the people who are employed by the device industry" said co-author Ernst Berndt, Ph.D., Louis E. Seley Professor in Applied Economics, MIT Sloan School of Management. "Congress should carefully weigh any policies that could increase health care costs and reduce high-paying jobs, particularly during an economic downturn."
The authors' research highlights the consequences to multiple stakeholders - patients and the public health, medical device inventors and manufacturers, their employees and the government - if medical device preemption were eliminated. For example,
Patients' access to medical devices and the benefits they provide would be reduced; as prices increase, products may be withdrawn, and fewer new products will be developed.
Physicians will increasingly practice defensive medicine to avoid litigation and expose patients to added risks of otherwise unnecessary procedures.
For those employed by the medical device industry, the increased manufacturers' costs would discourage investment in medical device development, reducing the R&D pipeline of innovative new products created and brought to market, and lead to layoffs of high-paying jobs.
Medical innovation would be affected, as decisions about health care products shift from expert, science-based regulators to untrained, non-expert juries, creating a duplicative, fragmented and inconsistent national framework administered by state and federal courts.
The government would experience increased costs, as Medicare and Medicaid spend more than they otherwise would due to fewer new product innovations, and government pays for increasing judicial system, tort and duplicative state regulatory costs.
"The question is not whether eliminating preemption will reduce innovation, but rather by how much and how rapidly," said co-author Mark Trusheim, Visiting Scientist at the MIT Sloan School of Management. "High levels of tort risk discourage investment in new technology. Eliminating preemption substantially alters the benefit/risk ratio of complex medical devices, increases the costs for all stakeholders, and negatively affects patients' future access to treatment options."
"Given these findings, and current economic circumstances, Congress should carefully consider any change to current law as the ramifications could substantially harm patient choice and health," Trusheim concluded.
The report was made possible by a grant from the Advanced Medical Technology Association. The views expressed are those of the authors only, and do not necessarily reflect views of the sponsor or MIT.
SOURCE Berndt Associates
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