Abbott Labs to Pay FDA Fine, Halt Some Sales

Abbott Laboratories Inc., the nation’s largest maker of medical diagnostic tests, agreed Tuesday to pay a $100-million fine and stop selling more than 100 products until it corrects repeated violations of federal quality rules.

The company’s violations date to 1993, said the Food and Drug Administration, which sought a consent decree to settle the issue because Abbott did not correct the problems despite six years of government inspections and warnings.

A federal judge Tuesday finalized the consent decree, which addresses about 300 diagnostic products.

The $100-million payment is the largest amount of money ever paid by a company regulated by the Food and Drug Administration for a civil violation of the Food, Drug and Cosmetic Act, according to the FDA.

Under the consent decree, Abbott is permitted to sell only diagnostic tests or devices that the FDA deems medically necessary, about 175 products. Those include tests that detect the AIDS virus and hepatitis in donated blood.

The FDA found no evidence that those particular blood tests were inaccurate. As an added safeguard, the FDA reinspects blood before deciding which batches can be transfused.

But Abbott is barred from selling 125 other products until manufacturing at its Illinois factory meets federal quality rules. Competitors sell alternatives for each of those tests, and Abbott’s sales will stop in 30 days, time to allow laboratories to pick another supplier and restock.

Abbott is not required to recall any tests, and patients who had their blood or other tissue samples tested at a laboratory using Abbott products are not advised to be retested, the FDA said.

“The issues have to do with manufacturing processes and not with known instances of patient harm,” said Dr. David Feigal, the FDA’s medical devices chief.

In agreeing to the consent decree, Abbott did not acknowledge wrongdoing.

Abbott lost $2.31, or 6%, to close at $38 on the New York Stock Exchange.