"First Things First: Fix the FDA" (From Those Who Practically Destroyed It)

Newt Gingrich, Andrew von Eschenbach and Wayne Oliver, of the Center for Health Transformation, wrote a blog post recently that you might find interesting.

Deadly Medicine: A Look at Clinical Trials Overseas

from an unexpected source, Vanity Fair.

Are More Pharma cGMP Whistleblower Cases on the Way? Experts Think So.

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...

Lady Gaga and Beyonce's GSK Song

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.

Pharma CEOs' Big Question - Should I Stay Or Should I Go?

A growing number of pharma CEOs are now dealing with the consequences of failing to care about workplace realities and what Toyota called the gemba, or place where truth will be found.If the idea of reading a book on ethics or philosophy is too off-putting....after all, it has been a rough week....why not...

Pharmaceutical Manufacturing QC Whistleblower Receives $96 million

Pharma whistleblowers don't always fare too well...especially those who deal with the invisible world of manufacturing.  Remember Mark Livingston and the Wyeth Sarbanes-Oxley case? However, Cheryl Eckard, who pointed out manufacturing deficiencies at GSK's Cidra, Puerto Rico, plant has received a $96-million payment.  For more from The Guardian, read on.  They've included

FDA and Others Wonder, Is Training Problematic, or Symptomatic?

In the cover story of this month's issue of Pharmaceutical Manufacturing--Workforce Training: Embracing the "Necessary Evil"--I quote several industry consultants who suggest that FDA inspectors are taking a much closer looking at worker training issues than they have in the past, which is evidenced by an increase in mentions of...

EZ Pass Testing, Coercion and Buck Passing: A Tale of Broken Pharma QA and QC. Sound Familiar?

Just read Mina Kimes' enlightening account of the J&J McNeil quality disaster in Fortune. Forget about the fact that the adulterated products did not and most likely would not have harmed consumers, the problems cited are very serious and go straight to the heart of GMP's.

Wyeth's OpEx Legacy

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.