US Senator Wants Probe Into Pharma Outsourcing

Probably not a bad idea to look in to who and where some of the outsource companies would be. In other words would the FDA be outsourcing to US companies or would these too be companies located in other countries? Would there be an exclusion for the same country to manufacture and also inspect? Those are just some questions that come to mind and if the outsourcing is not limited to US companies, how about using some kind of check and balance system with one country responsible for inspecting another. Also, if a US companies are doing the work, will it be in turn outsourced to an off shore company affiliate or partner? There’s a lot to be said about “outsourcing” today, especially when it comes to mission critical pharmaceutical and device manufacturing, so exactly what is FDA Outsourcing all about? BD

Sherrod Brown, a Democrat from Ohio, has asked the FDA to disclose how it evaluates product safety and to make drugmakers more accountable for products that fail to meet standards. In particular, he expresses concern over drugmakers that “take advantage of weak drug safety standards abroad.”

http://www.pharmalot.com/2008/06/us-senator-ants-probe-into-pharma-outsourcing/