PAR PHARMACEUTICAL SETTLES GOVERNMENT INVESTIGATION, AGREES TO PAY $2.5 MILLION IN FINES
PAR PHARMACEUTICAL SETTLES GOVERNMENT INVESTIGATION,
AGREES TO PAY $2.5 MILLION IN FINES
SPRING VALLEY, N.Y., Nov. 21 /PRNewswire/ -- Pharmaceutical Resources, Inc. (NYSE, PSE: PRX), the parent company of Par Pharmaceutical, Inc., announced today that Par has entered into agreements with the office of the U.S. Attorney for the District of Maryland and the civil division of the Department of Justice to settle the federal government's two-year investigation of Par.
Under the agreement with the U.S. Attorney, which is subject to court approval, Par agreed, among other things, to plead guilty to ten violations of the United States Code and pay a total fine of $2,500,000. Par also agreed to continue to cooperate fully with ongoing FDA inquiries into Par's regulatory compliance. The charges, which relate to acts occurring between March 1986 and July 1989, include making false statements to a government agency, obstruction of an FDA investigation, and distribution of adulterated or misbranded drugs. $1,250,000 of the fine is payable 60 days following sentencing, $625,000 24 months after sentencing, and $625,000 12 months after the second payment.
Kenneth I. Sawyer, president and chief executive officer of Pharmaceutical Resources, Inc., said, "We are pleased that this agreement will bring to a close the government's criminal investigation of Par. The behavior that gave rise to the investigation and to this agreement is totally unacceptable, and not in accord with our corporate philosophy. During the past two years, we have made the changes necessary to see that such behavior will not recur. We have replaced all management personnel who had any involvement in the illegal activities. We have strengthened our board of directors, and it is substantially independent from management. Most importantly, we have made sweeping improvements in personnel and procedures designed to ensure compliance with our approved product applications and good manufacturing practices requirements." Sawyer noted that there had been no problems as to the safety or efficacy of any of the drugs that Par is currently marketing that are mentioned in any of the charges.
Sawyer further stated, "We are pleased that this agreement removes one of the major legal obstacles that Par faced. With this behind us, we can devote increased efforts to resolving all remaining matters and to rebuilding our tablet and capsule business. We will continue to demonstrate to our customers, the government, our shareholders, and the public, our commitment to manufacture and distribute only quality pharmaceutical products, to conduct our business in accordance with high standards of integrity, and to operate our business profitably. We firmly believe that we can achieve these goals."
/CONTACT: Michael A. Swit of Pharmaceutical Resources, 914-425-7100/
(PRX) CO: Pharmaceutical Resources, Inc. ST: New York IN: MTC SU: SM-OS -- NY048 -- 5880 11/21/91 12:11 EST