Putting a Price Tag on Noncompliance

A survey that came out late last year attempted to put an actual figure on the cost of pharma quality problems.  Should make it easier for some of you to get funding for those QbD/PAT/process control projects. We hope. For more, read on.

"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.

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

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.

PAT Won't Be Mandated (But Don't Look for Any New Incentives Either): CDER Deputy Director Webber

At this week's FDA meeting on PAT and QbD, someone in the audience asked CDER Deputy Director Keith Webber, who had spoken about PAT, QbD, process validation (old vs. new) and real time release vs. end of line testing, whether FDA would ever require PAT.

Genzyme Reported to be Likely to Enter into Consent Decree With FDA

Genzyme is likely to enter into a Consent Decree with FDA over ongoing cGMP problems at its Allston facility. The company says that FDA plans enforcement action.  Here, reporting from Wall Street Journal today. Blogger Jim Edwards notes a 14-year history of compliance issues at Genzyme on his blog today.

Ali Afnan to Leave FDA

This week, the FDA will lose its most eloquent advocate for process analytical technologies (PAT): Ali Afnan, senior staff fellow at CDER's OPS. who leaves the Agency this Friday to pursue a career in independent consulting. A member of the original PAT team led by Ajaz Hussain, Dr. Afnan had pioneered...