Angie Drakulich's PharmaTech Talk post from this morning discussed how increases in mergers and rising prominence of drug manufacturers outside the US are affecting FDA workload with regard to inspections. Here's a few eye-popping stats from her post:
- Between 2001-07 the number of manufacturers in China increased 7-fold and 25-fold in India
- FDA inspections outside the US grew by 53% between 2005-09
- Foreign inspections totalled 222, with 44 in China, 95 in India and 83 in EU
- Only 2% of inspections were for cause
- The number of NDA and supplements to the FDA that reference foreign sites increased from 229 in 2003 to 293 in 2009 (approx 28%)
Merger activity also has its challenges. There have been delays in reporting and field alerts to the FDA post-merger. Firms are having challenges integrating quality systems. Training new staff is an issue. Legacy products are being acquired without accompanying process knowledge. Holy Process Gap Analysis Batman! Product quality and manufacturing site control have lagged in mergers.
The FDA's Edwin Rivera-Martinez pointed out that now is a good time for all drug manufacturers to ensure that they have a global, modern, comprehensive, robust, CGMP quality system in place. Here. Here.
Posted by Bruce Lehr September 14th 2010.