Saturday, May 23, 2015

Drug manufacturing problems and malfeasance span the globe

Ranbaxy provided another example this week that drug companies the world over are sometimes willing to skirt rules and laws, while ignoring public and patient safety.

Drug manufacturing problems and malfeasance span the globe

Ranbaxy Laboratories, Ltd., is an India-based pharmaceutical company with a U.S. subsidiary, Ranbaxy USA Inc., headquartered in Parsippany, N.J.

Ranbaxy provided another example this week that drug companies the world over are sometimes willing to skirt rules and laws, while ignoring public and patient safety.

The Justice Department said Monday that it had reached the largest drug safety settlement to date with a generic drug manufacturer. Ranbaxy agreed to pay $500 million and plead guilty to criminal charges relating to the manufacture and distribution of certain drugs made at two of Ranbaxy’s facilities in India. The Justice Department statement is here.

The government was helped by a former Ranbaxy employee and whistleblower, Dinesh Thakur. He was born in India but worked in New Jersey for 10 years at Bristol-Myers Squibb before joining Ranbaxy. He will get a piece of the settlement.

Before anybody gets all jingoistic, similar problems occurred with American companies and American personnel in plants near Philadelphia.

Ranbaxy issued a statement that said the problems occurred under previous management and that current management cooperated with the Justice Department.

Fortune magazine spent a lot time digging into Ranbaxy and the magazine said its story (here) is "based on more than 1,000 confidential Ranbaxy documents, including internal reports, memos, e-mails, hundreds of pages of FDA documents obtained through Freedom of Information Act requests, and court records. Fortune interviewed more than a dozen former and current employees, as well as 40 scientists, public health experts, patient advocates, congressional investigators, and regulators."

 

 

About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com.

David Sell