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Patients' access to medical devices and the benefits they provide would be reduced; as prices increase, products may be withdrawn, and fewer new products will be developed.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:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson ... Recently, he has implemented orthobiologic procedures as a method for treating his patients. ... the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons ...
(Date:6/24/2016)... Michigan (PRWEB) , ... June 24, 2016 , ... Those ... deal with these feelings, many turn to unhealthy avenues, such as drug or alcohol ... of Marne, Michigan, has released tools for healthy coping following a traumatic event. , ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that ... chosen by their peers for this recognition are considered among the top 2 percent ... special honors as members of this year’s Legal Elite Hall of Fame: Miami ...
(Date:6/24/2016)... , ... June 24, 2016 , ... People across the ... Genome magazine’s Code Talker Award, an essay contest in which patients and their families ... to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... actively feeding the Frederick area economy by obtaining investment capital for emerging technology ... past 2½ years that have already resulted in more than a million dollars ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... HILL, N.C. , June 24, 2016 /PRNewswire/ ... healthcare decisions and regulators/payers have placed more emphasis ... new environment, patient support programs in the pharmaceutical ... for patients, medications. Consequently, pharmaceutical companies are focusing ... ensure they are providing products and services that ...
(Date:6/24/2016)... , June 24, 2016   Bay Area ... Network,s Dean Center for Tick Borne Illness ... and Rehabilitation, MIT Hacking Medicine, University of California, ... today announced the five finalists of Lyme ... disease.  More than 100 scientists, clinicians, researchers, entrepreneurs, ...
(Date:6/24/2016)... Va. , June 24, 2016 The ... set of recommendations that would allow biopharmaceutical ... (HCEI) with entities that make formulary and coverage decisions, ... the "value" of new medicines. The recommendations ... does not appear on the drug label, a prohibition ...
Breaking Medicine Technology: