The statistics are there in black and white. In 2001, there were roughly 1200 foreign manufacturing plants for pharmaceuticals. In 2008, there were 3500. That's an 185% increase. The FDA increased its inspections by 23% but that only led to a 57% decrease in the foreign plant inspection rate.
What to do about it? The FDA is touting a 4 point plan. The plan calls for the following:
- Partnering with foreign counterparts to creat a global coalition of regulators
- Building a global data information system
- Improve intelligence gathering and focus more on risk analytics
- Tap both public and private sources - like foreign regulators
Some of this process has begun for years now according to deputy FDA commissioner John Taylor, but the efforts need to be stepped up. In meantime, he said "another pubic health crisis like Heparin seems inevitable." Not a cheery thought.
Posted by Bruce Lehr March 15th 2011.