FDA Update – April 20, 2009

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Update – April 20, 2009

FDA Issues Warning Letter to Human
Testing Firm

FDA Issues Warning Letter to Human Testing Firm
A congressional probe has prompted the U.S. Food and Drug Administration (FDA) to send a warning letter to Coast Independent Review Board, a company that monitors testing of experimental drugs and medical devices on humans.

The agency identified “serious violations” of several federal rules that protect human subjects. A congressional hearing last month exposed flaws in experiments that could put patients at risk.
The Colorado Springs, Colo. based firm is cooperating and said it would halt consideration of new experiments and stop enrollment in research trials already under way.

A fictitious testing protocol submitted from the Government Accountability Office got the green light from Coast IRB that allegedly involved pouring a liter of a product into a woman's stomach following surgery. Two other companies approached by the GAO denied the proposal.

The FDA’s action will affect 300 human studies. Coast IRB will have show how they comply to the FDA concerns on the W/L before the restrictions can be lifted.

Visit www.fda.gov/cder/warn/2009/Coast_IRB_letter.pdf for the complete warning letter.

For more information on this article, please email mdi at info@mdiconsultants.com and reference Human testing.

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