P99-26 FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE Sharon Snider: 301-827-6242
November 2, 1999
Consumer Inquiries: 888-INFO-FDA
The decree was signed today by Judge Harry D. Leinenweber in Chicago.
Abbott is one of five major in-vitro diagnostic device manufacturers in the world and the largest in the United States. Abbott's Diagnostics Division makes some 325 laboratory tests, including tests used for diagnosing disease and for screening for infectious diseases in blood used for transfusion.
Over the past six years, Abbott has failed to comply with FDA's Good Manufacturing Practice and Quality System (GMP/QS) regulation. Despite warnings from FDA, Abbott has failed to correct its problems.
"This action underscores FDA's strong commitment to the enforcement of laws designed to protect patients and consumers," said Jane E. Henney, M.D., Commissioner of Food and Drugs. "These violations do not necessarily mean that Abbott's diagnostic products will harm patients, but the firm's failure to follow good manufacturing requirements decreases the level of assurance," she added.
FDA is not recommending that diagnostic tests be repeated for those patients whose initial testing was performed using Abbott's in vitro diagnostic test kits.
Abbott's manufacturing practices first raised FDA concern in 1993, when deficiencies in good manufacturing practice were found during FDA inspections of the firm's Abbott Park, Ill., and North Chicago, Ill., manufacturing facilities. Violations were found in process validation, production and process control, and corrective and preventive action.
After these inspections, FDA sent a warning letter to Abbott in March 1994. Subsequent FDA inspections during 1995, 1996, 1997 and 1998 continued to find the same types of deficiencies. FDA tried to work with Abbott to correct these problems without seeking relief from the courts. However, when the firm failed to meet promised completion dates and failed to correct problems adequately, FDA sent another warning letter in March 1999 and re-inspected the facilities during May, June and July. During that inspection, FDA found continuing deficiencies and decided that a court order would be necessary to ensure that the firmís processes were brought into compliance in a timely and orderly fashion.
Under the consent decree, signed by Abbott and two of its top corporate executives, FDA will allow the firm to continue distributing certain medically necessary tests for screening blood donors for infectious blood-borne diseases such as HIV, hepatitis B and hepatitis C. Such tests are already subjected to lot release by FDA as an additional control, and there is no evidence that they have been ineffective.
All other Abbott in vitro diagnostic devices will remain available for 30 days, to permit users to standardize and obtain alternate test methods. FDA recommends the use of additional quality control material (reagents used to help verify the proper functioning of test kits) made by other companies to increase the assurance of successful performance of Abbott tests.
After 30 days from the effective date of this agreement, Abbott will no longer be permitted to manufacture or distribute non-medically necessary tests.
Abbott will also continue distributing a number of tests to laboratories. These include tests for identifying tumors, tests to detect heart attack, and tests to monitor levels of therapeutic drugs.
Abbott has agreed to comply with FDA's Quality Systems Regulation for these products according to a schedule approved by FDA. The firm has also agreed to pay $15,000 per manufacturing process, per day, (up to $10 million dollars cap) for failure to adhere to that schedule.
The firm has also agreed to pay $100,000,000.00 to the U.S. Treasury within 10 days after the decree has been entered by the court. The amount covered is described in the complaint filed by the court as the equitable remedy of disgorgement. It sets a precedent as the largest amount of money ever paid by an FDA-regulated company for a civil violation of the Federal Food, Drug and Cosmetic Act.
In addition, if the medically necessary products are not brought into compliance within one year after the court enters the decree, the company agreed to pay 16 percent of the gross proceeds generated by the sales of such products as determined by an independent financial auditor.
In the meantime, FDA will be notifying the medical community by letter about specific precautions that may be taken regarding continued use of these products.
Information will also be available, as appropriate, via the internet at www.FDA.gov/cdrh/ and www.FDA.gov/cber/. Updated information will also be available from FDA's Center for Devices and Radiological Health (CDRH), Division of Small Manufacturers Assistance at 1-800-638-2041 and from the Center for Biologics at 1-800-835-4709.
Abbott has agreed to correct deficiencies in its manufacturing operations for all other 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 re-inspect Abbott's facilities to verify that the products have been validated and that the manufacturing processes conform to the Quality System Regulation. At that point, the products can once again be permitted on the market.
Once corrective action is complete and Abbott has been allowed to resume manufacturing and distribution, the company will hire an independent auditor to conduct audit inspections of its in-vitro diagnostic device manufacturing operations at least twice a year for at least four years.
Results of these audit inspections will be reported directly to FDA. If Abbott fails to comply with the Quality System Regulation or the terms of the consent decree, FDA may order the firm to again stop manufacturing and distributing, recall the products, or take other action.
The executive officers named in the consent decree for permanent injunction are: Miles D. White, Chief Executive Officer, Abbott Laboratories, and Thomas D. Brown, President of Abbott's Diagnostics Division. Abbott's corporate headquarters is in Abbott Park, Ill. The Diagnostic Division's primary manufacturing facilities are in Abbott Park and North Chicago.