The contentious negotiations between Bayer and the 400 or so unionized workers at its Berkeley, California biotech facility have become a test case for whether workers in pharma/biopharma (and other industries) have any leverage whatsoever in the face of potential or expected downsizing and outsourcing.

We've just published, in print and online, our latest cover story: “The Good Fight: The Plight of Pharma’s Middle Managers.” It’s a rich, timely topic, given the fact that much of the finger pointing regarding the industry's problems is aimed at mid-level professionals. Or they are implicitly faulted, as upper management absolves itself of responsibility.

Change management has become an important and accepted aspect of corporate success in recent years. Companies are beginning to understand that anticipating major change—whether it be in terms of products, processes, or people—and having a systematic methodology for handling it makes a lot of sense—to the stability of the organization and contentment of workers.

Middle managers in the life sciences are underappreciated and underrated in their significance, and yet they're often the first individuals to be blamed for operational issues or to be laid off during restructurings.

ostrich

The ostrich has become a staple of many pharmaceutical science presentations of late, symbolizing an industry that is reluctant to change. Perhaps it could symbolize some of the more shortsighted pharma CEO's at this point in the 21st century. With all due respect, as CEOs face a tough balancing act today, I have a few questions for this elite group:

Most of the U.S. Department of Justice’s major pharma-related decisions invoking the False Claims Act recently have involved illegal marketing and sales. So far, GSK’s is the only one to deal with current good manufacturing practices (cGMP’s).  Read on for a roundup of the top 20 recent cases from Taxpayers Against Fraud (TAF).

Uberblogger Pharmagossip and the expert satirist Pharmagiles recently posted riffs inspired by the GSK whistleblower case, with Pharmagiles setting the lyrics to Harry Belafonte's famous Banana Boat Song. Click here for a view.

Did any of you catch that recent WSJ report on the negative impact of mass layoffs? OK, I know that M&A layoffs are different, but today brought the sad news that Pfizer/Wyeth will lay off 6,000 employees and close eight of its manufacturing plants in Ireland, Puerto Rico and the U.S.

The saga of KV Pharmaceutical provides a cautionary tale for any manufacturer who would overlook manufacturing quality issues and attempt to fly under the regulatory radar. As most in the industry know, KV has gone from a model growth company to one on the brink of bankruptcy, following manufacturing issues which included the production of oversized tablets (some of which contained double doses of API), and then subsequent attempts to falsify records and cover up the problems. 

FDA has been advocating process knowledge and understanding for a long time now. The Agency's statements always generate "hear, hear's" and motherhood-and-apple-pie type assents and approvals among industry types...."Of course, we need to understand our processes."

But at times I wonder: Is everyone paying attention? Is anyone? Must full-out production always trump product quality and patient safety?