CEI Criticizes FDA Delay In Approving New Heart Valve

Washington, DC, July 27, 2001—The Food and Drug Administration acted far too slowly in approving the Omnicarbon heart valve, the Competitive Enterprise Institute charged today.  The valve was approved by the agency late yesterday, 15 years after the application for the device was filed.  The Omnicarbon valve has been available since at least 1986 in such countries as Italy, Germany, France, Switzerland, and Japan.<?xml:namespace prefix = o ns = “urn:schemas-microsoft-com:office:office” />


“While the FDA is being criticized for supposedly approving new drugs and devices too quickly, this episode demonstrates just the opposite,” said CEI Policy Analyst Sam Kazman.  “The FDA is afflicted by deadly overcaution.  Delay may protect the agency politically, but it can mean death to patients in need.”


The U.S. application for the Omnicarbon valve was filed in 1986.  The FDA denied the application in 1989, requesting more information.  Ironically, the device was developed in the U.S., and for at least 15 years has been manufactured here and exported with FDA approval.  Only now, however, will it actually be available to physicians and patients in this country.


Nearly 30,000 Omnicarbon valves have been implanted in patients in other countries.  In congressional testimony in 1998, Dr. Steven Phillips of the National Institutes of Health stated that these valves “demonstrated a complication rate one-half that of equivalent valves approved by FDA”.  The valve is made of a pyrolytic carbon.  Older mechanical valves can cause thromboembolisms.  For that reason, they must be used with anti-clotting drugs, but these drugs increase the risk of hemorrhage. The Omnicarbon’s pyrolytic construction significantly reduces embolism risk.  Given the fact that approximately 16,000 heart valve recipients per year in the U.S. experience bleeding complications, many of them fatal, the Omnicarbon valve offers major life-saving benefits—benefits which were denied to the American public due to the FDA’s 15-year delay.


CEI has long been involved in the issue of FDA reform.  In a 1996 CEI poll of cardiologists, 65% held the view that the FDA approval process is too slow.  That view has been confirmed by similar polls of oncologists and other medical specialists.



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