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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Patients' access to medical devices and the benefits they provide would be reduced; as prices increase, products may be withdrawn, and fewer new products will be developed.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 i
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SOURCE Berndt Associates
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