New FDA System to Track Safety of Drugs and Devices

Monday, July 14, 2008 by: Jo Hartley
Tags: health devices, health news, Natural News

(NewsTarget) U.S. health officials have announced plans for a new computer tracking system that has been designed to help identify specific dangers stemming from prescription drugs and medical devices that are currently on the market.

This system would enable the Food and Drug Administration (FDA) to search certain databases for possible evidence of side effects. These databases include, but are not limited to, the government's Medicare health insurance plan.

The new system is called the Sentinel System, and it is designed to better track risks that may emerge from more widespread use of products in the marketplace.

The FDA's safety monitoring has long been criticized for its inadequacies and slowness. This especially came to light in 2004 after Merck & Co Inc's withdrawal of its painkiller Vioxx. Vioxx was pulled from the market after it was linked to increased risk of heart attacks and strokes in patients.

This new system effectively moves the FDA from a reactive position of relying on voluntary reporting to a proactive position of surveilling the medical products that are available to patients on today's market.

Under the current system, the FDA relies mostly on voluntary reports about potential side effects. Issues are under-reported because only the manufacturers of products are required to submit them to the FDA. Physicians and patients are free to submit information, but these submissions are voluntary.

With the Sentinel System, the FDA will be able to search claims data from private health insurers, hospitals, and Medicare to determine if problems exist with patients.

Eventually, the FDA will be able to examine data bases of millions of patients. They will be in a proactive position of investigation rather than a reactive position of simply waiting for reports to be submitted.

Initially, the FDA's first project will be to examine information from over 25 million patients who have prescription drug coverage under Medicare. This data will also be available to states and other academic researchers if desired. Patient names will not be included.

This plan has been met with approval from consumer groups, who are excited about the improvements being made in the current system.

The only drawback is wondering how much priority this system will be given and how the FDA plans to initiate these changes with its tight budget and staff. At this point it is uncertain how much time will be necessary to implement the program. Some estimates indicate that pertinent information about Medicare patients could possibly be available within one year. Other information would take longer.

This new system will help fulfill the Congressional requirements that were passed last year set up to strengthen the FDA's supervision of the pharmaceutical industry.

About the author

Jo Hartley
Wife, Mother of 8, and Grandmother of 2
Jo is a 41 year old home educator who has always gravitated toward a natural approach to life. She enjoys learning as much as possible about just about anything!
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