I apologize if some of my columns over the years have seemed a bit negative or critical.  As a publication, we started up at a time when thought leaders pointed out the seemingly limitless potential to improve and modernize manufacturing.  

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?

This just in from FDA....

We wanted to criticize, in as forceful and graphic a way as possible, the cynical attitude of the compounding facility management, to call attention to the disgraceful conditions that were found at many of the compounding facilities that were inspected, and also to draw some attention to the political situation (e.g.

Just received confirmation of last post.  Here's the official letter announcing changes from CDER Director, Dr. Janet Woodcock

 CDER Staff:

I want to inform you about some important proposed organizational changes for CDER.

Haven't confirmed any of this yet, but just heard rumors of change, and another 'superoffice' restructuring at FDA. Apparently, within the new framework, the Office of Generic Drugs will become a "superoffice", OPS will be no more, while OMPQ, ONDQA and OBP will report to OPQ.  The Office of Compliance will continue to take on more of an enforcement role.

Seems fitting that OGD should have a much more prominent place, given that most prescriptions being written and dispensed in the U.S. today are generics.

Again, more on this soon.

Agnes Shanley 

Four Reasons Why You Should Do it, Three Reasons Why You're Not

On Monday, June 18th, BIO 2012 was much more subdued than I’d remembered seeing it in the past.  However, it was just the first official day, and a number of breakout sessions touched on important topics. 

Perhaps the most important of these topics is drug shortages.  A panel of professionals from regulatory, manufacturing and patient welfare backgrounds discussed the topic. Kevin Whalen of Pfizer’s worldwide policy group, chaired the session, with:

Lou Di Genero, EVP and CSO for Leukemia and Lymophoma Society

Gerry Migliaccio, SVP Pfizer Global Supply Chain

At the ISPE/FDA conference on cGMP’s in Baltimore last week, Andrew Skibo, EVP of operations and manufacturing at MedImmune, spoke on the topic of “High Quality in a Lean Manufacturing World.”  The pharmaceutical industry’s increasing focus on reducing manufacturing costs, he said, has come at a time when the industry is also seeing a dramatic increase in quality failures.  Biopharmaceuticals, so closely defined by their manufacturing processes and environments, are p

Those who cover green and sustainability issues know that Pharma is pretty progressive. No, the industry's not perfect, certainly, but many of its leading companies also make it a point to be leaders in environmental stewardship. While more drug companies are successfully jumping on the green bandwagon, it's getting harder and harder to find projects that make a real difference. In other words, the low-hanging fruit has been picked. So what's next?