Court enters permanent injunction against Crown Labs after alleged distribution of misbranded drugs

By Mark Iandolo | Aug 2, 2017

WASHINGTON (Legal Newsline) — The U.S. Department of Justice announced July 27 that the U.S. District Court for the Eastern District of Tennessee entered a consent decree of permanent injunction against Crown Laboratories Inc. and Chief Executive Officer Jeffrey Bedard to stop the alleged distribution of unapproved and misbranded drugs.

According to the department, the defendants violated the federal Food, Drug and Cosmetic Act by introducing unapproved and misbranded drugs into interstate commerce. Crown Laboratories purportedly sold dermatological creams without U.S. Food and Drug Administration (FDA) approval and without sufficient evidence the products were safe and effective.

“The public has a right to assume that drugs in the marketplace are safe, effective, have obtained proper approvals, and are labeled with the information necessary to allow for proper use,” said acting assistant attorney general Chad Readler of the Justice Department’s Civil Division. “Where drug manufacturers violate these fundamental requirements, the Department of Justice will continue to work aggressively with the FDA to ensure that the pharmaceutical industry follows the rules. Doing so is necessary to protect American consumers.”

Handling the case for the department was trial attorney Mary M. Englehart of the Civil Division’s Consumer Protection Branch, with the assistance of associate chief counsel for enforcement Susan Williams of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.

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