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ABBOTT LABORATORIES TO REMEDY DEFICIENCIES

WASHINGTON, D.C. -- Abbott Laboratories, an Illinois-based drug and medical device manufacturer, has accepted the terms of an injunction that requires the company to take measures to comply with Food and Drug Administration (FDA) regulations and pay $100 million of expected profits to the United States to resolve allegations that the company's methods and facilities for manufacturing in vitro diagnostic devices are not in compliance with FDA good manufacturing requirements, the Department of Justice announced today.

The in vitro devices are used to diagnose diseases and other conditions, including heart conditions, drug overdoses, and pregnancy.

Acting Assistant Attorney General David W. Ogden of the Civil Division said the settlement resolves allegations that Abbott had failed over several years to implement and maintain procedures required by FDA's Quality System Regulation for medical devices. This reduced the assurance that Abbott's in vitro diagnostic devices can be relied upon to perform consistently and accurately. Abbott, as well as the company's chief executive officer, Miles D. White, and the president of Abbott's Diagnostics Division, Thomas D. Brown, agreed to be bound by an injunction requiring that specific remedial measures be taken to ensure that Abbott comes into compliance with FDA's regulation.

Under the terms of the injunction, which was entered today by U.S. District Judge Harry D. Leinenweber, Abbott will be required to cease manufacturing and distributing almost 300 in vitro diagnostic devices at two Abbott facilities in Illinois. The company cannot resume marketing these devices until an independent expert certifies to FDA, and FDA concurs in the expert's assessment, that Abbott has brought its operations into compliance with FDA's regulation. For at least four years after Abbott achieves compliance, the company must conduct regular audits of its operations and make reports to FDA concerning its continuing compliance.

The injunction makes special provision for certain Abbott devices that FDA believes are medically necessary, and thus should remain on the market in the interest of the public health. Abbott will continue to produce and distribute approximately 50 such devices while it works to achieve compliance with FDA's quality requirements for these devices, but will give up a portion of its expected profits from these devices by paying the government an equitable monetary settlement of $100 million.

Abbott also must make additional payments if it fails to bring these medically necessary products into compliance within a time-frame set by FDA. The medically necessary products include tests for AIDS, hepatitis, and other critical conditions. Such tests are already subjected to lot release by FDA as an additional control, and there is no evidence that they have been ineffective.

The settlement, and the government's complaint, were filed today in U.S. District Court for the Northern District of Illinois in Chicago. The settlement was negotiated by the Department of Justice's Civil Division, Office of Consumer Litigation, and the Food and Drug Administration's Office of Chief Counsel, Center For Devices and Radiological Health, and Center for Biologics Evaluation and Research.

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