Thursday, February 7, 2008

FDA Fines Red Cross $4.6 Million

The American Red Cross, the biggest operator of U.S. blood banks, was fined $4.6 million after regulators found that it failed to properly screen blood donations.

The Food and Drug Administration sent a letter to the Red Cross yesterday describing the agency's findings, said FDA spokeswoman Peper Long. The penalty followed an FDA review of blood that was recalled by the Red Cross, she said.

Regulators have fined the Red Cross more than $20 million since the FDA and Red Cross entered into a legal agreement in 2003 allowing penalties for failing to follow federal standards to ensure blood is not contaminated, Long said.

There is no indication patients were harmed by the failures associated with the fine, the FDA said.

Regulators identified 113 blood recalls from 2003 to 2006 that could have been prevented if the Red Cross, based in the District, had followed procedures. The Red Cross did not perform required tests on the blood and failed to ask donors questions to determine their eligibility, Long said.

The Red Cross is reviewing the FDA letter and has taken steps to improve compliance with the rules, said Eva Quinley, senior vice president of quality and regulatory affairs for blood.

Jefferson Charges to Remain

A judge refused to toss out an indictment against a Louisiana congressman accused of taking bribes, rejecting the argument that the indictment unconstitutionally infringed on his privileges as a congressman.

Attorneys for Rep. William J. Jefferson, a Democrat, sought to have most of the indictment against their client thrown out, arguing that testimony given by his staffers to the grand jury violated the Constitution's speech or debate clause. It says that congressmen "shall not be questioned in any other Place" for speech or debate associated with their legislative work.

Prosecutors argued that if the defense theory were accepted, it would become virtually impossible to ever charge a congressman with a crime.

U.S. District Judge T.S. Ellis III ruled that Jefferson's attorneys were trying to apply the principle too broadly. "It's not an expansive immunity. It's a focused immunity," Ellis said in making his ruling.

Drug-Marketing Crackdown Set

U.S. regulators said they would crack down on marketing of an unapproved injectable anti-gout drug that has been linked to 23 deaths.

The Food and Drug Administration said injected forms of the drug, colchicine, can be highly toxic, and may lead to organ failure and death in excessive doses.

The FDA said the manufacturers, which it did not name, must stop shipping the product within 180 days or face enforcement action that could include seizure, injunction or other legal measures.

-- From News Services

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