Chronimed Acknowledges FDA Warning Letter
MINNEAPOLIS, March 24, 1999 -- Chronimed Inc. (Nasdaq: CHMD), acknowledged today that it received a warning letter from the Food & Drug Administration (FDA) regarding its Eden Prairie, MN production facility. The “warning letter”, dated March 3, 1999, contends that deficiencies were found in Chronimed's methods of complying with certain requirements of federal food and drug law applicable to the company during an FDA inspection that took place in December of 1998. A “warning letter” is a written communication to a firm alleging violations of federal food and drug law and requesting prompt correction.
According to Maury Taylor, Chronimed's Chairman and CEO, “We consider any correspondence from the FDA as serious. Consequently, upon receipt of the letter, Chronimed took immediate steps to correct the issues raised by the FDA. Further, we have been in contact with the FDA and have assured them we are committed to fully resolving all of the concerns raised by the agency. Finally, we have already formally responded to the FDA's concerns and expect no further regulatory action.”
Henry F. Blissenbach, Pharm.D., Chronimed's President and Chief Operating Officer continued, “We recognize that issues of this sort can create uncertainties for all of our constituents. However, the FDA has not required us to stop shipping our product, so investors and patients alike should not be concerned about supply interruptions in our diabetic test strips. Many people with chronic medical illnesses depend upon Chronimed products and services in the management of their health condition. Chronimed is committed to ensuring that our products meet the requirements of the law and continue to enhance our customers' quality of life.”
Chronimed Inc. is a leading integrated healthcare company specializing in diagnostic products, pharmacy services, and disease management for people with chronic health conditions. The Company develops, manufactures, markets, and distributes pharmaceuticals, medical diagnostic products, and provides specialized patient management services nationwide for people with long-term chronic conditions such as HIV/AIDS, diabetes, organ transplants, and diseases treated with injectable medications. Chronimed works directly with patients, providers, and payors to improve clinical and cost-of-care outcomes. Chronimed's web site address is www.chronimed.com.
As a cautionary note to investors, certain matters discussed in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such matters involve risks and uncertainties that may cause actual results to differ materially, including the following: changes in economic conditions; general competitive factors; the Company's ability to execute its service and product sales plans; changes in the status of managed care contracts; and the risks described from time to time in the Company's SEC reports.
March 13, 2000
Contacts:
Paul S. Dunn
Investor Relations
or
Maurice R. Taylor, II
Chairman and CEO
Chronimed Inc.
(612) 979-3600