The FDA this week sent U.S. Marshals into an Ohio warehouse to seize more than $11 million worth of drugs marketed by Ascend Pharmaceuticals which it claims are unapproved. But a mention in the FDA press release that the drugs were warehoused by Masters Pharmaceutical has brought a world of pain down on the third-party logistics company.
Ben Maizel, president of pharma logistics company RXTPL, a division of Masters, said his company's role has been misunderstood by mainstream media whose reports were seized on by competitors to try to steal his clients. He said the company has heard from clients, friends and family, and companies with which it does business, wanting it to confirm that it had done nothing wrong.
However, beseiged by a raft of news reports suggesting RXTPL and Masters Pharmaceutical were selling unapproved drugs, it sent out a press release of its own Wednesday calling the FDA's depiction of its company as "inaccurate and significantly misleading" with respect to Masters and RXTPL. It clarified that it did not own, manufacture or market the drugs the FDA seized.
"We are a third party logistics company," Maizel said Wednesday. "We get the merchandise from the manufacturer, whoever it is. We warehouse. We don't sell it. We don't get a commission on the product. They send us orders and we deliver to companies like McKesson and Cardinal."
In the company response, Masters' CEO, Dennis Smith, said that Masters and RXTPL would "never knowingly sell unsafe drugs to any customer." He said the company has fully cooperated with the FDA since it arrived to seize the products. "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."
The FDA responded in an email Wednesday that "the press release stands for itself. We have nothing further to add." Montvale, NJ-based Ascend Laboratories, a division of India's Alkem Laboratories, has not had anything itself to say. It did not respond to FiercePharmaManufacturing's request for a comment and Maizel said RXTPL has not gotten any kind of response from its "large and loyal customer" since marshals took custody of the drugs.
The FDA in its announcement said that the drugmaker was told last November after an inspection at Ascend Laboratories that the drugs needed to be run through the agency's approval process to be marketed in the U.S. It said the seized products included pramoxine-HC otic drops for treating ear infections; hydrocortisone acetate suppositories for treating inflamed hemorrhoids, ulcerative colitis and other inflammatory conditions; and urea cream and urea lotion for treating conditions like dermatitis and eczema. It put the total value of the products at $11.185 million.
The FDA action also comes as the agency has been paying closer attention to regulatory compliance by drugmakers in India, a country that accounts for about 40% of the generic and over-the-counter products used in the U.S.
- read the company release
- here's what the FDA said