Healthcare Industry News:  Baxter International 

Devices FDA

 News Release - June 29, 2006

Baxter and FDA Reach Agreement on Next Steps for U.S. Infusion Pumps

DEERFIELD, Ill., June 29 (HSMN NewsFeed) -- Baxter Healthcare Corporation announced today that it has reached agreement on a consent decree with the U.S. Food and Drug Administration (FDA) regarding the company's COLLEAGUE and SYNDEO infusion pumps. The agreement has been approved by the U.S. District Court for the Northern District of Illinois.

The agreement, which is limited to Baxter's COLLEAGUE and SYNDEO infusion pumps, outlines the steps the company must take to resume sales of new pumps in the United States. The steps include obtaining FDA approval of Baxter's plan to resolve issues with the pumps currently in use in the U.S., third-party expert reviews of COLLEAGUE and SYNDEO operations and other measures to ensure compliance with the FDA's Quality System Regulations. The agreement resolves a court action by the FDA that began with a seizure of pumps in Baxter's northern Illinois warehouses in October 2005, which followed field corrective action notices about COLLEAGUE and SYNDEO that had been issued by the company.

"Patient well-being and safety are Baxter's top priorities," said Robert L. Parkinson, Jr., Baxter's chairman and chief executive officer. "The agreement we've reached with FDA provides a clear path to resolving the COLLEAGUE and SYNDEO issues, so that we may continue to serve patients and medical professionals by delivering the quality, reliability and innovation they expect from Baxter."

Before resuming sales in the U.S., the agreement allows the company to continue to service pumps currently in use and supply additional pumps to customers when medically necessary. No financial penalties have been imposed. The company will post a $20 million letter of credit which will be cancelled upon FDA's verification that Baxter has successfully reconditioned or destroyed the seized COLLEAGUE and SYNDEO pumps. The agreement also allows the FDA to take additional actions it deems necessary to ensure compliance.

Within 20 days, the company will submit for FDA review and approval a corrective action plan describing proposed upgrades and modifications for pumps currently in use. When authorized, the company will immediately begin deployment of the plan. Pumps currently in the market continue to be safe to use when operated according to the user manual and instructions contained in previous customer communications. Once certain requirements outlined in the agreement are satisfied and FDA grants marketing clearance, Baxter may resume sales of COLLEAGUE and SYNDEO pumps in the U.S.

Currently, more than 200,000 COLLEAGUE infusion pumps are in use in U.S. hospitals. Approximately 50,000 are used abroad and are not affected by this agreement. Deployment of COLLEAGUE modifications outside of the U.S. has already begun in 30 countries and is expected to be substantially completed by the end of this year.

For certain customer accommodations and to adjust reserves previously established for remediation costs, the company expects to record a second quarter after-tax charge of up to $70 million (or $.11 per diluted share). Excluding this charge, the announcement does not affect the company's financial outlook for the second quarter or full-year 2006. Baxter will host a conference call for investors today at 5 p.m. EDT (4 p.m. CDT). A webcast of the call can be accessed on the company's website at http://www.baxter.com or investors may participate by calling (866) 837-9779 domestically or (703) 639-1417 internationally.

Baxter Healthcare Corporation is a subsidiary of Baxter International Inc. (NYSE: BAX ). Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.

This release includes forward-looking statements concerning the company's COLLEAGUE and SYNDEO pumps. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the company's ability to satisfactorily complete enhancements to its systems, processes, controls, and products; additional product development steps; product quality or patient safety issues; additional experience with remediation and accommodation costs; and the other factors identified in the company's most recent filing on Form 10-Q and other SEC filings, all of which are available on the company's web site. The company does not undertake to update its forward-looking statements.


Source: Baxter Healthcare

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