Red Cross, FDA to face hearing in January on dispute over blood safety violations

Friday, December 14th 2001, 12:00 am
By: News On 6

WASHINGTON (AP) _ A federal judge set a January hearing on the government's effort to impose severe fines on the Red Cross over violations of blood safety rules.

At the same time, Judge John Garrett Penn on Friday directed the two sides to continue trying to settle their differences through mediation.

``This is an important case,'' Penn said. ``It's important to the confidence of the American people that it be resolved.''

Penn scheduled a hearing for Jan. 11 on the Food and Drug Administration's request that the Red Cross be held in contempt of court and that the FDA be allowed to impose fines for future rules violations.

``This is not just a dispute about money, it's a dispute about public health,'' FDA lawyer Lawrence McDade told the court.

In court papers filed Thursday, the FDA charged that ``persistent and serious violations'' continue despite a 1993 federal court order mandating improvements in blood handling by the Red Cross.

McDade said that while the nation's blood supply is safe, the goal is to eliminate all risks that can be eliminated.

The Red Cross said in a statement that it has invested more than $280 million to upgrade its blood operations to meet FDA requirements, and believes ``the nation's blood supply has never been safer than it is today.''

Penn ordered the safety dispute into mediation last summer. Both sides praised the mediator but said their differences remain unresolved.

``Mediation has not produced the results the Red Cross desired,'' Red Cross lawyer Ty Cobb said. The new effort to impose fines may hamper efforts to reach an agreement, he added.

``We regret deeply the status of the mediation. The effort to get the FDA to the table and keep them there has been a challenging one,'' Cobb said.

McDade agreed that mediation has not led to the conclusion the FDA wants, adding that may not be possible without judicial action.

Still, Penn said he would like to see the mediation continue. If that does not resolve the issue, he said, then he would set a schedule at the Jan. 11 hearing to pursue the FDA's request for a contempt citation.

The Red Cross, which provides about 45 percent of the nation's blood supply, said it will fight the health agency over the fines. In a statement, the Red Cross said the FDA wants to take action ``beyond the legal authority granted by Congress.''

The FDA's most recent inspections of Red Cross facilities have found:

_Release of blood possibly tainted with cytomegalovirus, which can kill, blind or cause brain damage in newborns.

_Failure to properly defer certain donors with syphilis, and failure to properly update and check a national registry of unsuitable donors.

_Computer errors that could cause the release of blood before it has been through all safety testing.

The FDA is seeking permission to fine the Red Cross $10,000 a day for each new violation it discovers. If blood has to be recalled, fines could climb to $50,000 per unit of recalled blood.

Those fines could add up to millions of dollars a year.

The violation of a single rule doesn't necessarily mean a health hazard, the FDA said, because regulations set overlapping safeguards of the blood supply.

``The risk of not receiving a needed transfusion far outweighs the risk of receiving blood,'' FDA acting commissioner Bernard Schwetz said.

The FDA action is the latest in a series of recent public black eyes for the Red Cross. It came under sharp criticism and had to backtrack from a plan to divert to other uses some of the half-billion dollars donated to help the terrorist victims.

At the same time, the Red Cross provoked tension with other blood banks by seeking massive blood donations following Sept. 11, even after it became clear supplies were sufficient. It wound up discarding some 6 percent of donated red cells.