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District Court Issues Permanent Injunction to Seller of Unapproved Dermatological Drugs

August 4, 2017

The U.S. District Court for the Eastern District of Tennessee entered a permanent injunction against Crown Laboratories of Johnson City and its CEO, Jeffrey Bedard, after accusations of distributing unapproved and misbranded drugs. The company’s products, which include urea creams and lotions intended to treat dermatological problems, were sold and distributed without FDA approval or a sufficient demonstration of their safety and efficacy, according to the complaint the Justice Department filed in March at the request of the FDA.

Several of Crown’s products were sold with an indication for treatment of dry, rough skin, skin cracks and fissures, dermatitis, xerosis, icthyosis, eczema, calluses, and psoriasis. One of its products, Sodium Sulfacetamide, was indicated for acne vulgaris, seborrheic dermatitis and acne rosacea. All of these uses required FDA approval, which was not secured.

Crown agreed to settle the case and comply with the permanent injunction, halting all manufacturing, sale and introduction into interstate commerce of the products in question or any drug with similar labeling and APIs without approval. The defendants also must give the FDA notice that they are prepared to destroy all the products in question and any similarly unapproved products.

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