Pop quiz!  Where did the following snippets from FDA citations come from? (Winner gets a free coffee mug, runner up gets two -:))

• Contamination during the manufacture of serum injectables?
• Failure to measure or account for endotoxins?  
• Failure to respond to adverse patient reactions?  
• Presence of vermin and unsanitary conditions at the facility?

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).

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.

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?

The drug industry is usually out front in assisting disaster relief, and many manufacturers have already come forth with major donations of money and supplies to Haiti in the aftermath of this week's earthquake.

Abbott will donate $1 million and says it has donated drugs that are already "on the ground" in Haiti. 

Some of those in favor of relaxed reimportation often argue that the drug industry is fear mongering when it points to potential safety problems with drugs or ingredients sourced from abroad. "Be afraid, be very afraid. "  Well, recent events have shown that there is reason for fear....or at least for extreme caution when ensuring the pedigree of any raw materials  sourced from abroad.