DOJ Probing International Pharmaceutical Manufacturing

Earlier this year, we noted that a new enforcement focus for the U.S. Department of Justice (DOJ) will be increased oversight to ensure compliance with the Food and Drug Administration's (FDA) current good manufacturing practices (cGMPs) regulations. Specifically, Maame Ewusi-Mensah Frimpong, Deputy Assistant Attorney General (DAAG) for DOJ's Consumer Protection Branch (CPB), noted her division has long worked closely with FDA to promote the safety of pharmaceutical products.    Several months later, it appears that DOJ is acting on this promise in two recent cases. As reported by the Washington Post, Reuters, and FiercePharmaManufacturing, "U.S. federal investigators have taken an interest in manufacturing at an AstraZeneca plant in England." AstraZeneca confirmed that it received a "subpoena duces tecum" from the U.S. Attorney's Office in Boston. The feds were asking for "documents and records related to manufacturing, quality or good manufacturing practices" at its plant in Macclesfield, the Washington Post reports. The plant in Macclesfield is the company's second largest manufacturing facility, with about 800 employees, Reuters said. It also packages drugs for 130 markets around the world. Reuters also pointed out that the plant has a unique production line for making Zoladex, a treatment for hormone-sensitive breast and prostate cancer. The plant has been the manufacturing site for AZ's psychotropic drug Seroquel, for which it paid $520 million in 201...
Source: Policy and Medicine - Category: Health Medicine and Bioethics Commentators Authors: Source Type: blogs