United States Attorney's Office District of Connecticut
Press Release

P.F. LABORATORIES AGREES TO PAY $2,000,000 TO RESOLVE DEA CIVIL PENALTY DISPUTE
Settlement with U.S. involves violations relating to the manufacture of Oxycontin

Kevin J. O'Connor, United States Attorney for the District of Connecticut, and Karen P. Tandy, Administrator of the United States Drug Enforcement Administration, today announced that P.F. Laboratories Inc. of Totowa, New Jersey, an affiliate of Purdue Pharma ("Purdue") of Stamford, Connecticut, has agreed to pay the United States $2,000,000 to settle alleged record keeping deficiencies regarding its Oxycontin manufacturing facilities located in Totowa. The Government alleged similar violations at Purdue manufacturing affiliates in Ardsely, New York and Wilson, North Carolina.

"Vigorous enforcement of the civil penalty provisions available to the United States under the Controlled Substances Act sends an important message to industry that shoddy record keeping will not be tolerated where the regulation of controlled substances is concerned," U.S. Attorney O'Connor stated. "Diversion of legitimately manufactured substances is a problem that affects the health, safety and welfare of the country."

The Drug Enforcement Administration (DEA) investigation revealed that Purdue failed to keep accurate records and make accurate reports under the laws designed to safeguard the public against diversion of the most abused classes of legally manufactured and prescribed drugs. Oxycontin is a Schedule II narcotic drug, the most closely regulated schedule of legitimate pharmaceutical controlled substances. As a direct result of the investigation, Purdue has taken significant steps to bring each of its facilities into full compliance with the law and has stated that the facilities have substantially remediated the alleged violations.

The settlement states that the Government had alleged a broad array of violations, including failure to keep accurate inventories and improperly listing different controlled substances awaiting destruction.

"The Purdue Pharma settlement sends an unequivocal message: When DEA registrants fail to maintain the records required by law to ensure that potent drugs like OxyContin are not lost or stolen, they endanger the American public. Such violators will be discovered, investigated, and penalized to safeguard America ," said DEA Administrator Tandy.

Congress, with the passage of Controlled Substances Act, Title 21,United States Code, Section 801 et seq., took steps to attempt to create "a closed system" of distribution for controlled substances in which every facet of the handling of the substances – from their manufacture to their consumption by the ultimate user – was to be subject to pervasive government controls. The law was designed to prevent the diversion and abuse of legitimate controlled substances, while at the same time ensuring an adequate supply of those substances needed to meet the medical and scientific needs of the United States.

Oxycontin, an opioid analgesic drug sold in tablet form in varying strengths, is a controlled release form of oxycodone hydrochloride, which was first approved by the Food and Drug Administration in December 1995.

Purdue, in signing the settlement, has denied violating the law. The agreement recited that Purdue only signed the settlement agreement to resolve its differences with the Government and does not admit to any wrongdoing.

The investigation was conducted by investigators from the Drug Enforcement Administration's Office of Diversion Control in New York City, Newark, New Jersey, and Greensboro, North Carolina. The prosecution was lead by Assistant U.S. Attorney Alan M. Soloway.

CONTACT:

U.S. ATTORNEY'S OFFICE
Tom Carson
(203) 821-3722
thomas.carson@usdoj.gov