Masters Pharmaceutical Responds To FDA On Ohio Drug Seizures
By Cyndi Root
Masters Pharmaceutical issued a press release disputing the Food and Drug Administration’s (FDA) position on the raid at Master’s subsidiary RXTPL. The FDA and U.S. Marshalls went to RXTPL’s logistics facility in Fairfield, Ohio on Thursday, May 15, 2014. The government had a search warrant based on a November 2013 inspection at Ascend Laboratories, which showed the use of unapproved drugs. Masters says that RXTPL cooperated with the government in quarantining the drugs at the facility. However, Masters takes issue with the FDA press release that states that Masters was the “distributor” of the drugs because it suggests that Masters is the owner of the drugs.
In its original release, the FDA said, “U.S. Marshals, at the request of the U.S. Food and Drug Administration and the U.S. Attorney for the Southern District of Ohio, have seized more than $11,185,000 worth of unapproved drugs marketed by Ascend Laboratories of Montvale, N.J. and held by Masters Pharmaceuticals, Inc. of Cincinnati, Ohio.”
Dennis Smith, CEO of Masters, said, “We have never and would never knowingly sell unsafe drugs to any customer. The products involved here are not owned or sold by RXTPL.”
Masters Response
Master’s response calls the FDA’s news release “inaccurate, significantly misleading, unfair, and incorrect.” Masters denies that it owns, manufactures, or markets the unapproved drugs. The RXTPL division is a third-party logistics provider for companies without warehousing and distribution facilities. Masters states that RXTPL is just one of many logistics providers across the country. Specifically, Ascend Laboratories rents warehouse space and contracts for staffing, shipping, and other services from RXTPL. Neither Masters nor RXTPL own or market any products at the Ohio facility.