FDA Threatens Red Cross With Fines
Fri Aug 22, 5:48 AM ET Add U.S. National - AP to My
By LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - The government is threatening the American Red
Cross (news -
web sites) with thousands of dollars in fines for allegedly
court settlement that was supposed to end continuing disputes
In April, the Food and Drug Administration (news - web sites)
agreement to settle charges that the Red Cross had committed
serious violations" of federal blood safety rules dating
back 17 years.
That settlement spelled out changes the Red Cross must make to
FDA rules - such as ensuring that no patient receives
blood and rejecting donations from improper donors.
For the first time, the settlement gave FDA authority to
the Red Cross for violations.
On June 3, the Red Cross submitted its plans to make some of
changes, those dealing with how officials would investigate
quality-assurance problems that might arise.
In a warning letter, dated July 22 but released by the FDA on
government told the Red Cross that its plans do not fully
comply with the
court settlement because they leave out some specifically
As a result, the FDA said it intends to fine the Red Cross up
to $10,000 a
day for every day it was in violation of the agreement -
counting from June
3 through Aug. 6, when the Red Cross responded to the
"Their proposal didn't contain the level of safeguards we
wanted to help
assure that unsafe blood was not given to patients," said
FDA spokesman Brad
Stone. "There will be fines. We are determining what they
The Red Cross said it had already met several of the
requirements but was working to rectify this problem.
"We ... are taking swift actions to implement solutions
to meet FDA
requirements and to assist in assuring the safety of the
supply," Red Cross Vice President Ramesh Thadani said in
The Red Cross and FDA are negotiating the fines.
Thadani said the Red Cross will not use donations from the
public to pay the
FDA fines. The Red Cross provides about half the nation's
selling blood products to health facilities.
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