AstraZeneca hears from prosecutor, not FDA, about cGMPs at U.K. plant

When it comes to good manufacturing standards, it is the FDA that generally takes the lead to ensure drugmakers are making the grade. If a company has been particularly lax in the way it manufactures products, then the agency might call on federal prosecutors to write up and enforce a consent decree, like it did with Ranbaxy Laboratories in 2011, but it is rare for prosecutors to be asking on their own for information on cGMP issues.  

In a new twist, U.S. federal investigators have taken an interest in manufacturing at an AstraZeneca ($AZN) plant in England. The company today would only acknowledge that it had gotten 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 company is cooperating, but CFO Simon Lowth refused to give any specifics during an earnings call with reporters, according to Reuters.

The plant in Macclesfield is the the company's second largest manufacturing facility, with about 800 employees, Reuters said. It also packages drugs for 130 markets around the world. The news service points out that it has a unique production line for making Zoladex, a treatment for hormone-sensitive breast and prostate cancer.

The Macclesfield plant also has been the manufacturing site for its psychotropic drug Seroquel, for which it paid $520 million in 2010 to settle allegations that it used various ploys to get doctors to write off-label prescriptions for its psychotropic drug. The U.S. Army is currently doing trials into the use of Seroquel and other similar drugs, which some military doctors have prescribed for treatment of post traumatic stress syndrome. The company last year lost patent protection for the one-time blockbuster.  But whether there is any connection between the subpoena and either of those drugs, Lowth wouldn't say. "It's a very early approach," he told reporters.

Ranbaxy in 2011 signed a 5-year consent decree with U.S. authorities after the FDA found big problems at two manufacturing plants in India and discovered the Indian drugmaker had faked some data it provided to the agency.

- here's the Washington Post story
- get more from Reuters

Special Report: Seroquel - Pharma's Top 11 Marketing Settlements: AstraZeneca