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Physician-Patient Alliance for Health & Safety: Can There Be Too Much FDA Oversight?
Date:1/19/2012

CHICAGO, Jan. 19, 2012 /PRNewswire/ -- According to Marcia Crosse (Director, Health Care at GAO), FDA's ability to fulfill its mission to protect American health has been compromised. In her comments on why oversight of medical devices was placed on GAO's High-Risk List, she says:

"The Food and Drug Administration plays a key role in protecting the health of all Americans. FDA's role is far-reaching: from over-the-counter pain relievers to vaccines to prescription drugs to every medical device in your doctor's office or your local hospital. FDA is responsible for assuring the safety and effectiveness of every medical product before it is approved. After approval, FDA has a duty to ensure the continuing safety of hundreds of thousands of different medical products, regardless of whether they are manufactured here or abroad, and more than eight million shipments of medical products arrive at US ports in a single year. But, FDA is having difficulties in meeting its responsibilities."

With so many tasks, resource management is one of many priorities. As the GAO points out, "FDA has encountered difficulties in fulfilling its growing medical product responsibilities and does not have reliable estimates of its resource requirements or data showing its workload and accomplishments in some areas."

Moreover, strategic planning is a necessity. Says the GAO in its report, "Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-Term Planning Is Needed":

"To help ensure that FDA's overseas offices are able to fully meet their mission of helping to ensure the safety of imported products, the Commissioner of FDA should ensure, as it completes its strategic planni
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SOURCE Physician-Patient Alliance for Health & Safety
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