More than $11 Million of Unapproved Drugs Seized by U.S. Marshals in Ohio

Over $11,185,000 worth of unapproved drugs were confiscated by U.S. Marshals at an Ohio distribution facility. The seizure request was made on behalf of the FDA an the U.S. Attorney for the Southern District of Ohio after an investigation in November of 2013 revealed Ascend Laboratories of Montvale, New Jersey, and Masters Pharmaceuticals, Inc., of Cincinnati, Ohio were marketing and distributing drugs that had not been approved by the FDA. The FDA announced this seizure in accordance with its enforcement policies and warned consumers that have used the seized products to consult with a physician before continuing use.

Seized Products

A variety of products were seized from the Ohio facility including: (1) pramoxine-HC otic drops, which are used to treat external ear infections caused by microbes as well as to control itching; (2) hydrocortisone acetate suppositories 25 mg, which treats inflamed hemorrhoids and ulcerative colitis as well as other inflammatory conditions; and (3) urea cream and lotion products used to treat dermatitis and eczema. The complaint alleged that these products were not only unapproved by the FDA but misbranded under the federal Food, Drug, and Cosmetic Act (FDC Act). The complaint was filed after an inspection at the Ascend Laboratories during which it was discovered that drug products that had not been approved via the FDA’s new drug approval process were being marketed.

Enforcement Policy

According to the FDA Marketed Unapproved Drugs Compliance Policy Guide, any unapproved new drugs that are marketed after September 9, 2011, are subject to immediate seizure at any time and without notice. Moreover, the guide emphasizes that the FDA “is not required to, and generally does not intend to, give special notice that a drug may be subject to an enforcement policy.”

In regard to the seizure of these products, Carol Bennett, the acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research noted, “[c]ompanies that disregard the law put the American consumers at risk.” The FDA further commented that “none of these products [that were seized] had been proven safe or effective for their intended uses.”