Four Democrats in the House have been circulating a "draft", that if adopted, would increase funding for the FDA to do foreign manufacturing inspections, as well as increased domestic inspections. The proposal comes in response to the celebrated issues of tainted pharmaceutical ingredients, e.g. Heparin, coming from overseas manufacturers. China in particular has been involved in several cases of tainted raw materials.
The draft requires the following:
- Parity between the number of foreign and domestic inpections
- Increases in the number of pre-approval inspections
- Bans entry of drugs into the US lacking safety documentation
- Requires manufacturers to monitor and ensure safety of their supply chain
- Grants the FDA mandatory recall powers for unsafe drugs (duh!)
Sounds good right? I'm sure there is someone out there who objects. We also may have the usual political wrangling to look forward to as the mid-term elections approach.
Posted by Bruce Lehr September 21st 2010.