Printer Friendly

BARR RESPONDS TO FDA LAWSUIT

BARR RESPONDS TO FDA LAWSUIT
 POMONA, N.Y., June 15 /PRNewswire/ -- In response to the Food and Drug Administration's (FDA) lawsuit filed on Friday, June 12, Barr Laboratories, Inc. (AMEX: BRL) said the FDA's allegations are either untrue or misrepresentative but consistent with the agency's pattern of retaliation against the company which testified against the agency in Congress in 1989. While the FDA lawsuit seeks to prohibit Barr from manufacturing or selling any drug products, the company said it welcomes the opportunity to bring resolution to more than a year of FDA investigations and three years of harassment.
 "Now that we are in court, we will finally be operating in a forum where there are some rules," said Edwin A. Cohen, Barr's president. "We have endured FDA on-site inspections of unprecedented length; the FDA's creating on-the-spot ad hoc policy changes with no assurance that they are being applied equally to other drug companies; the FDA's placing Barr on its 'McCarthy-like' Alert List, which has no legal basis, and which has stopped approval of scores of our applications for new drugs; and the FDA's stone-walling for 15 months our application for a generic version of AZT. We're prepared for our day in court, and we're confident."
 As a result of the FDA's filing on June 12, U.S. District Judge Gerald L. Goettel, based in White Plains, N.Y., scheduled a preliminary hearing for June 24, 1992 at which time he will decide whether or not to grant the FDA's request on an interim basis. "Barr continues to be in full production," said Cohen, "and we're confident that after a full review of the facts by the court, we will still be in full production."
 The FDA filing of its lawsuit comes two months after Barr filed its own lawsuit with the federal District Court in Newark, N.J. seeking to enjoin the FDA from enforcing the "Alert List," an extra-legal device used by the FDA, and to enjoin the FDA from enforcing as legal requirements, "informal," unwritten and often conflicting standards and policies of FDA officials that are not subject to the normal and required rulemaking process. Most of the FDA's allegations against Barr contend that the company has violated the informal rules that the company is contesting in New Jersey.
 The FDA action also comes after 15 months of inspection. Barr has been cooperating with lengthy FDA on-site visits and investigations, and negotiating with the FDA for the past eight months in an attempt to resolve issues. During its most recent inspection in March 1992, the FDA inspectors acknowledged that Barr had already met the commitments made following the June-September 1991 inspection.
 The FDA's ongoing inspections have uncovered no incidents of fraud, misrepresentations, deception or any similar unlawful acts. All of Barr's products are safe and effective for their intended use, and are in strict conformance with all applicable pharmaceutical industry standards.
 -0- 06/15/92
 CONTACT: Edwin A. Cohen of Barr Laboratories, 914-362-1100
 (BRL) CO: BARR LABORATORIES, INC. IN: MTC ST: NY,NJ -- NY024 -- X464 06/15/92
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Jun 15, 1992
Words:510
Previous Article:FIRST AUSTRALIA PRIME INCOME FUND ANNOUNCES DIVIDEND
Next Article:INTERSPEC INTRODUCES NEW ULTRASOUND SYSTEM -- APOGEE CX200
Topics:


Related Articles
BARR LABORATORIES AND FDA MEET WITH DISTRICT COURT JUDGE WOLIN
BARR AND FDA RESUME COURT HEARINGS
BARR LABORATORIES, FDA SETTLE 1992 COURT CASE; COURT'S ORDER ESTABLISHES PROCESS FOR COMPANY TO REINTRODUCE FORMER PRODUCTS
Cephalon files narcolepsy patent infringement lawsuit.
ADDERALL XR(R) - Shire Files Legal Suit Against Barr Laboratories and Impax Laboratories for Infringement of U.S. Patent No. 6,913,768.
ADDERALL XR(R) - Shire Files Legal Suit Against Barr Laboratories and Impax Laboratories for Infringement of U.S. Patent No. 6,913,768.
U.S. Court of Appeals Denies Rehearing Request in Dismissal of Tamoxifen Citrate Antitrust Lawsuits.
Warner Chilcott Files Lawsuit Against Barr Laboratories, Inc. for Infringement of FEMCON FE Patent.
Shire Files Lawsuit Against Barr Laboratories for Infringement of FOSRENOL(R) (Lanthanum Carbonate) Patents.

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters