Pharma and FDA have been cutting back on staffing and employee training to save short-term costs, in a move that will cost them dearly in the long term. The results have already been seen at FDA, whose leaders plan to reverse this trend.
Is this simply the result of greed (OK, that wouldn't be possible at FDA), or are entropy and inertia at work? That is the question that our contributing editor and editorial advisor, Emil Ciurczak asked in his latest editorial. As a physical chemist, Emil likes to fit everything in the Procrustean bed of thermodynamics, but he claims he's never been wrong.
He just finished doing some consulting work in PAT/NIR for a pharma company, only to realize, minutes into the initial meeting with his client, that the same facility and company had called on him to do an identical project back in the 1990s. The names involved had changed, but not the technical issues.
The problem, of course: only one expert charged with NIR/PAT, nobody else trained and no knowledge transfer. Scenarios like this are playing out in pharma plants every day, all around the world. Is it any wonder that drugs are so expensive?
For more, read on.
