Johnson & Johnson Settles with United States Over Recordkeeping of Controlled Substances
AUG 11 -- Philadelphia, PA – Acting United Stated Attorney Laurie Magid announced that Johnson & Johnson has agreed to pay $511,000 in fines to the U.S. Government for failing to report importations of drugs under the Controlled Substances Act.
Johnson &Johnson owns a facility in Lititz, Pennsylvania, formerly owned by Warner-Lambert. From 2001 until 2005, Warner-Lambert owned and opertated the facility and, on 73 occasions, imported Benedryl-D, a product containing pseudophedrine. Warner-Lambert did not file any Form 486s with DEA for these importations. Johnson & Johnson, which now owns the facility through its wholly owned subsidiary, McNeil-PPC Inc., has agreed to pay $511,000 in fines for Warner-Lambert’s failure to report the pseudophedrine importation to DEA.
The Controlled Substances Act requires those who import, distribute and dispense controlled substances to report to DEA any importation of such drugs. Such reports allow DEA to track drugs that, although legal when prescribed by a physician, are commonly abused and sold illegally. The Act imposes civil penalties for violation of its record keeping and filing requirements as incentive for importers to help DEA combat illegal diversion of these drugs. One provision of the Act is the requirement that an import declaration, DEA Form 486, be filed within 15 days of the importation of products containing specified chemicals used in manufacturing controlled substances, such as pseudophedrine.
DEA’s Diversion Control Program regulates pharmaceutical and chemical companies to insure compliance with the laws governing their registration. As part of that compliance, companies are audited to ensure the regulations are being met and to safeguard the public from the diversion of those substances into the illicit market. When violations are discovered, DEA has the authority to take appropriated criminal, civil and/or administrative actions.
The case was investigated by DEA Drug Diversion Investigators and handled by The United States Attorney’s Office in the Eastern District of Pennsylvania.