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BARR LABORATORIES SUES FDA

 BARR LABORATORIES SUES FDA
 POMONA, N.Y., April 27 /PRNewswire/ -- Barr Laboratories, Inc.


(AMEX: BRL) announced today that it has filed suit in Federal District Court in Newark, N.J. to enjoin the Food and Drug Administration from enforcing the "Alert List," an extra-legal device employed by the FDA to prohibit firms from receiving new drug approvals, improving manufacturing procedures or selling products to federal agencies. The use of the "Alert List" is not authorized by law or government regulation and deprives firms that are listed of due process protections. In addition, Barr's suit also seeks to enjoin the FDA from enforcing "informal" and often conflicting policy statements made by FDA officials that are not subject the normal and required rulemaking procedures.
 Barr has more than 80 applications for new generic versions of drugs pending with the FDA, including a generic version of AZT, for which the National Institute of Health has already granted Barr a license.
 Barr has been cooperating with lengthy FDA on-site visits and investigations for the past 13 months, and negotiating with the FDA for the past six months in an attempt to resolve open issues without litigation. In its most recent inspection reports, the FDA acknowledged that Barr had addressed the issues raised by the 1991 inspection, yet Barr has remained on the "Alert List" with no opportunity for appeal.
 "The economic future of the company and the jobs of 550 union and non-union men and women in New York State and New Jersey are jeopardized by the illegal use of the 'Alert List'," said Edwin A. Cohen, president and CEO of Barr Laboratories.
 The FDA has uncovered no incidents of fraud, misrepresentations or deception of any similar unlawful acts.
 -0- 4/27/92
 /CONTACT: Edwin A. Cohen of Barr Laboratories, Inc., 914-362-1100/
 (BRL) CO: Barr Laboratories Inc. ST: New York IN: MTC SU:


AH-HM -- NY046 -- 3080 04/27/92 11:18 EDT
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Publication:PR Newswire
Date:Apr 27, 1992
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