Masters Pharmaceutical, Inc. Responds to Misleading Press Release Issued by U.S. FDA

Masters Pharmaceutical, Inc. Responds to Misleading Press Release Issued by U.S. FDA


May 21, 2014

RXTPL, a division of Masters Pharmaceutical, Inc., operates a third-party logistics facility at 8695 Seward Road in Fairfield, Ohio.  On Thursday, May 15, 2014, representatives from the U.S. Marshals and U.S. Food and Drug Administration appeared at RXTPL's facility with a seizure warrant for certain products manufactured by one of RXTPL's clients.  RXTPL fully cooperated with the government, and the products remain in RXTPL's possession under quarantine.

The following day, the FDA published a News Release entitled "U.S. Marshals Seize Unapproved Drugs from Ohio Distributor." In the Release, the Agency described Masters as the "distributor" of the unapproved drugs in question, and thereby suggests that the products were owned by, and seized from, Masters.

The FDA's News Release is inaccurate and significantly misleading with respect to Masters and its RXTPL division. It unfairly and incorrectly implies that Masters owned, manufactured, or marketed the products at issue, and that the products were seized from Masters.  None of this is true.

Masters, through its RXTPL division, acts as a "third-party logistics" provider for pharmaceutical manufacturers that lack their own warehousing and distribution capabilities. Many national wholesalers and distributors provide similar services.  In this role, RXTPL rents warehouse space to pharmaceutical manufacturers, and provides staffing and a variety of other services to fulfill its contractual obligations to its "3PL" clients.

RXTPL does not manufacture, own, or market any of the products located in its Fairfield, Ohio warehouse location. RXTPL simply stores products belonging to its clients, and ships those products, at its clients' direction, to wholesalers, chain pharmacies, and other licensed facilities throughout the United States and Puerto Rico that ultimately distribute them to the public.

Masters' CEO, Dennis Smith, stated that "Masters and RXTPL are committed to protecting the integrity of the pharmaceutical supply chain in the United States.  We have never and would never knowingly sell unsafe drugs to any customer.  The products involved here are not owned or sold by RXTPL.  We have cooperated fully with every request the FDA has made.  It is unbelievable that the FDA and the press can make such inaccurate statements regarding Masters' or RXTPL's role in the handling of these products.  They are owned and marketed by the manufacturer, and simply stored at RXTPL. The inaccurate statements made by various media outlets have armed our competitors with false information. Even now, our competitors are trying to capitalize on our business by further broadcasting these untruths. To think that some of our competitors would try to woo our customers by misrepresenting the facts, all for the sake of the almighty dollar, is truly sad. I think our customers are smarter than that. We have not and never will reduce ourselves to this deplorable method of selling at Masters, RXTPL or any other company that I own for that matter."

Masters Pharmaceutical, Inc. is one of the largest privately-owned companies in the Cincinnati area.

Media Inquiries: Ben Maizel, President
                        8695 Seward Road
                        Fairfield, OH 45011
                        [email protected]