FDA Cracks Down on Sonar For Distributing Unapproved Derm Drugs

U.S. District Judge Kathleen M. Williams for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Stratus Pharmaceuticals Inc. of Miami, Florida, Sonar Products Inc. of Carlstadt, New Jersey and two of the companies' officers, Alberto Hoyo and Juan Carlos Billoch.

Stratus and Sonar routinely shipped unapproved, improperly labeled (misbranded), and substandard or contaminated (adulterated) drugs in interstate commerce, according to the complaint filed with the consent decree. Specifically, Sonar manufactured and Stratus distributed a number of dermatological products, including various washes, creams and ointments that were not approved by the U.S. Food and Drug Administration, in violation of the Federal Food, Drug, and Cosmetic Act.

"These companies have endangered the public by selling products that have not been proven to be safe or effective and are poorly made," says Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, in a news release. "The agency will continue to take aggressive enforcement action against those who repeatedly violate the law and put consumers at risk."

In April 2015, U.S. Marshalls seized unapproved prescription drug products manufactured by Sonar and marketed and distributed by Stratus valued at more than $16 million. The unapproved products included:

• a solution marketed to treat excessive sweating;
• an antibiotic cleanser marketed for treatment of skin conditions, such as acne, rosacea and seborrhea;
• a topical ointment marketed to treat wounds;
• a topical cream and gel marketed to treat psoriasis, eczema and other skin conditions; and
• drops used to treat ear pain.

Additionally, FDA inspections since 2014 found that Stratus and Sonar violated current good manufacturing practice (CGMP) requirements. The inspectors found Stratus failed to properly handle more than 1,300 consumer complaints. Among other significant CGMP violations, Sonar manufactured and released adulterated drugs, used components that did not meet established standards or specifications, failed to properly clean manufacturing equipment and used test methods that lacked a scientific basis.

The consent decree requires Sonar to cease operations until, among other things, it hires a CGMP expert, corrects its violations and receives written permission from the FDA to resume operations. Stratus is further prohibited from distributing unapproved drugs until it obtains required FDA approvals for those products.

The complaint was filed by the U.S. Department of Justice on behalf of the FDA.