FDA Threatens Red Cross With Fines
Fri Aug 22, 5:48 AM ET  Add U.S. National - AP to My Yahoo!

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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 violating a
court settlement that was supposed to end continuing disputes over blood
safety rules.

In April, the Food and Drug Administration (news - web sites) reached an
agreement to settle charges that the Red Cross had committed "persistent and
serious violations" of federal blood safety rules dating back 17 years.

That settlement spelled out changes the Red Cross must make to comply with
FDA rules - such as ensuring that no patient receives potentially unsafe
blood and rejecting donations from improper donors.

For the first time, the settlement gave FDA authority to immediately fine
the Red Cross for violations.

On June 3, the Red Cross submitted its plans to make some of the required
changes, those dealing with how officials would investigate and correct
quality-assurance problems that might arise.

In a warning letter, dated July 22 but released by the FDA on Thursday, the
government told the Red Cross that its plans do not fully comply with the
court settlement because they leave out some specifically ordered changes.

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 government's
complaints.

"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 will be."

The Red Cross said it had already met several of the settlement's
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 nation's blood
supply," Red Cross Vice President Ramesh Thadani said in a statement.

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 blood supply,
selling blood products to health facilities.

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