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FDA Consumer magazine
May-June 2000
For failing to correct longstanding manufacturing violations, the nation's largest maker of laboratory diagnostic tests paid the heftiest sum ever sought by the Food and Drug Administration.
Abbott Laboratories, a multinational pharmaceutical and medical supply giant in Chicago, and two of its top corporate executives, Miles D. White and Thomas D. Brown, agreed on Nov. 4, 1999, under a consent decree of permanent injunction, to pay $100 million and to stop making and selling many of its 225 in vitro diagnostic tests until it corrects longstanding manufacturing problems. In vitro diagnostic tests are performed in laboratories on samples of patients' blood, urine, mucus, and other bodily fluids, and are used in diagnosing disease to determine the appropriate treatment.
Abbott failed both to comply with FDA's Current Good Manufacturing Practice (CGMP) regulation, now called the Quality System (QS) regulation, and to fulfill past commitments to correct existing deficiencies. Under the decree, Abbott was required to halt the manufacture and distribution of tests not medically necessary (those used for diagnosing less serious conditions) in the United States after Jan. 10, 2000.
FDA first raised concerns about Abbott's manufacturing practices in 1993, when routine inspections of the firm's facilities uncovered violations in process validation (a system that assures a product will consistently meet its predetermined specifications and work the way it is supposed to work), production and process controls, and corrective and preventive actions.
Following these inspections, FDA sent a warning letter to Abbott in October 1993, detailing the problems found. A subsequent inspection of the firm's facilities identified similar manufacturing problems, and a second warning letter was issued in March 1994. In 1995, Abbott agreed to a voluntary compliance plan to correct the problems. However, subsequent FDA inspections during 1997 and 1998 revealed the same types of deficiencies. FDA sent another warning letter in March 1999, when the firm failed to meet promised completion dates and to correct problems adequately.
The most recent inspection, which concluded on July 8, 1999, again revealed that the company was not in compliance with the CGMP/QS regulation, and that previous problems had not been corrected. At that time, FDA sought a court order to force the firm to bring its processes into compliance in a timely fashion.
The consent decree, signed by Judge Harry D. Leinenweber in Chicago, was not the first action FDA has taken against Abbott for production problems. In November 1998, the agency became concerned about an Abbott prescription drug called Abbokinase (urokinase) because of serious deficiencies in its manufacturing process, the testing of the product, and the screening and testing of the donors of kidney cells used to make the drug. Abbott is still in the process of correcting these problems, and as of early April, FDA was still not allowing distribution of the drug.
FDA examined Abbott's products and determined that patient care would be compromised if certain in vitro diagnostic devices were removed from the marketplace, such as several assays used in screening donor blood for transfusion and assays used in clinical chemistry testing, testing for cardiac markers, and monitoring therapeutic drug levels.
Abbott agreed to correct deficiencies in its manufacturing operations for all diagnostic tests as soon as possible. The corrections will be overseen by an outside expert, hired by Abbott, who will certify to FDA that corrections have been made. FDA will then re-inspect Abbott's facilities to verify that the manufacturing processes have been validated and that they conform to the CGMP/QS regulation. At that point, the products will be permitted on the market. Achieving full compliance with the CGMP/QS regulation could take a year or more.
Abbott's failure to comply with the CGMP/QS requirements does not mean that its in vitro diagnostic devices will necessarily fail to perform as intended. It does mean that users have less assurance of successful performance than they would have had these products been manufactured properly.
Certain in vitro diagnostic devices regulated by FDA's Center for Biologics Evaluation and Research are already subject to lot release assessment by FDA as an additional control. The lot release process provides an added assurance of the sensitivity of the test kits used to screen donor blood.
If Abbott's medically necessary products are not brought into compliance by Nov. 4, 2000, the company has agreed to pay 16 percent of the gross proceeds generated by the sales of such products, as determined by an independent financial auditor. Payments will continue until the products are brought into compliance.
Once Abbott achieves compliance and is allowed to resume full manufacturing and distribution of all its in vitro diagnostic tests, the company has agreed to hire an independent auditor to conduct audit inspections of its device manufacturing operations twice a year for at least four years. Results of those audit inspections will be reported directly to FDA. If Abbott fails to comply with the CGMP/QS regulation or the terms of the consent decree, FDA may order the firm to again stop manufacture and distribution, recall products, or take other action.
The $100 million payment sets a precedent as the largest amount of money ever paid by an FDA-regulated company for a violation of the Federal Food, Drug, and Cosmetic Act.
Carol Lewis is a staff writer for FDA Consumer.
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