FDA criticized for wait in warning blood recipients about hepatitis C
Web posted at: 8:06 p.m. EDT (0006 GMT)
WASHINGTON (CNN) -- A key lawmaker is charging that the Food and Drug Administration is not moving fast enough in alerting blood recipients about the risks they face from hepatitis C.
Roughly 300,000 of the 4 million Americans who have hepatitis C got it from blood transfusions.
Surgeon General David Satcher has pledged to oversee an aggressive notification program.
"Everyone we believe to be at risk for hepatitis C will be targeted by the department's plan," he said in March.
But Congressman Christopher Shays, R-Connecticut, says the FDA is dragging its feet.
"Dr. Satcher made a firm commitment that we would act fast and we aren't acting quickly," he said.
Hepatitis C can take years to set in, but when it does it can be fatal -- causing serious liver disease that often leads to the need for a liver transplant.
The FDA pledged to work with the blood and hospital industries on what they called a "look-back": Identifying infected donors who gave blood before July of 1992 when a reliable test to detect it became available. Affected recipients would then be alerted.
Shay said he is particularly unhappy that the FDA's efforts to move the warning process along were recently delayed another six months. And he said the FDA has been far too willing to give the blood and hospital industries more time to prepare.
The head of the FDA's advisory committee on blood safety, Art Kaplan, said he is also dissatisfied with the FDA's progress.
"The blood industry has been on notice that we expect a look-back in this area and yet delay seems to be the order of the day," he said.
The FDA declined to comment on the record for two days and said it is in the process of drafting a statement.
Secretary of Health and Human Services Donna Shalala said the government has been aggressive in its efforts, but concedes there's much to be done.
"Whether it's hepatitis C or the need to redesign the organ transplant system in this country, we have run out of time as far as we're concerned," she said.
About 10,000 people die each year from hepatitis C. Doctors recommend if you received a blood transfusion before 1992 -- even if you don't have any symptoms -- don't wait to get notified. Get tested now.
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