Navigation Links
Removing Medical Device Preemption Impacts Jobs, Health Care Costs, Patient Access
Date:5/6/2009

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Patients' access to medical devices and the benefits they provide would be reduced; as prices increase, products may be withdrawn, and fewer new products will be developed.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
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. National Multiple Sclerosis Society Commends President Obamas Initial Steps in Removing the Bans on Embryonic Stem Cell Research
2. Remedy for Cracked Heels and Removing Calluses
3. Indoor Allergy Week - Cleanaer™, the New Air Purifier that Helps Prevent Spread of the Common Cold While Removing Airborne Allergen
4. Wal-Mart & Nalgene Removing Toxic Bottles, Place Consumers Concerns First
5. Removing Ovaries Before Menopause Leads to Memory, Movement Troubles
6. Medical University of South Carolina Automates Grants Allocation Process with Lombardi Business Process Management Software
7. Symmetry Medical to Present at Bank of America and Merrill Lynch 2009 Healthcare Conference
8. Ajou University Hospital Becomes First in Korea to Treat Using RapidArc(TM) Radiotherapy Technology from Varian Medical Systems
9. New Jersey IT Services Firm to Host Educational Luncheon Event, EMR & Information Technology for the Specialty Medical Practice
10. For Medical Device Makers, Full Spectrum Software Releases Software Technology Report Called How to Survive in 2009 and Beyond
11. Local Medical Association Opposes Two State Propositions
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/9/2016)... ... February 09, 2016 , ... ... officially been won. A team from 21st Century Medicine (21CM) ( http://www.21cm.com/ ... preserve the delicate neural circuits of an intact rabbit brain for extremely long-term ...
(Date:2/8/2016)... ... February 08, 2016 , ... ... Nutrition into the Food & Beverage and Dietary Supplement ... partner throughout Canada and USA geographies east of the Rocky Mountains since 2012. ...
(Date:2/8/2016)... ... ... famous for gift giving with flowers, chocolates and other tokens of affection meant to remind ... than 5.6 million Americans suffering with Alzheimer’s, those store bought gifts - no matter ... they’ve led and the people they’ve touched. , That’s why Give To ...
(Date:2/8/2016)... , ... February 08, 2016 , ... If you are ... to handle, you are not alone. According to the Center for Disease Control and ... stroke, type 2 diabetes and certain types of cancer, some of the leading causes ...
(Date:2/8/2016)... IN (PRWEB) , ... February 08, 2016 , ... ... the Indianapolis, IN metro area, has selected the latest beneficiary of their ongoing ... organization dedicated to preventing bullying in area schools. Donations are now being accepted ...
Breaking Medicine News(10 mins):
(Date:2/9/2016)... Mast Therapeutics, Inc. (NYSE MKT: MSTX), ... disease and heart failure, today announced that it intends to ... stock in an underwritten public offering.  The offering is subject ... assurance as to whether or when the offering may be ... the offering.   --> --> ...
(Date:2/9/2016)... 9, 2016 The new report "Global Diagnostic Ultrasound Devices ... Consulting group reveals that global diagnostic ultrasound devices market was valued ... US$ 7,466.3 million by 2019 at a CAGR of 6.8% from ... ultrasound market has been analyzed for six geographies of ... Asia-Pacific , Latin America , ...
(Date:2/9/2016)... , Feb. 9, 2016 The leader ... that AcceleDent ® is the recipient of the ... category. An FDA-cleared, Class II medical device that speeds ... percent and relieves pain often associated with treatment, AcceleDent ... participated in the annual Orthotown survey of ...
Breaking Medicine Technology: