JOHNSON CITY, TN (WJHL) – The Department of Justice reports it has ordered Johnson City, TN-based Crown Laboratories and the firm’s CEO, Jeffrey Bedard, to stop the distribution of unapproved and misbranded drugs.
The U.S. District Court says it has entered a consent decree of permanent injunction against the company.
The DOJ filed a complaint in the Eastern District of Tennessee on March 1 at the request of the U.S. Food and Drug Administration. The products at issue include urea creams and lotions to treat a variety of skin ailments.
The complaint alleges the company violated “the federal Food, Drug and Cosmetic Act by, among other things, introducing unapproved and misbranded drugs into interstate commerce. Specifically, the complaint alleges that defendants sold a series of dermatological creams, despite the absence of FDA approval or a sufficient showing that these products were safe and effective.”WEB EXTRA:
- Crown Laboratories Consent Decree of Permanent Injunction(.pdf)
- Crown Laboratories Complaint for Permanent Injunction(.pdf)
“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.”
Crown manufactures a variety of prescription and over the counter drugs including prescription urea cream and lotion.
The complaint alleges various urea based products were sold as products intended to treat a series of dermatological conditions, such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratosis, and calluses.
Since the products are designed to provide dermatological treatment, the government says they product require FDA approval.
The FDA alleges that approval that was lacking for all of these products. It says, “distributing unapproved drugs in interstate commerce is a violation of the federal Food, Drug, and Cosmetic Act.”
Crown Laboratories has a facility on Lafe Cox Drive in Johnson City.
Crown Laboratories has agreed to settle the case and be bound by the injunction. The order requires Crown to stop manufacturing and selling the affected products — unless an application has been filed with the FDA and is approved by the agency.
The company has 20 days after the district court’s order to give the FDA a written notice that they are prepared to destroy the products.