Pew Health Group just issued the results of a study assessing weaknesses in the global pharma supply chain. Their conclusion? The FDA must be given oversight powers to ensure its integrity.
FDA must be empowered to oversee supply chain; report.
The report's recommendations for the FDA's role include: giving the agency the power to recall drugs, the power to subpoena witnesses and documents to speed investigations, and to be given resources to allow it to increase the rate of foreign inspections.
Manufacturer registration fees is one mechanism proposed to help fund more foreign plant inspections. Another suggestion is for the FDA to reduce its EU inspections by relying on its EU regulaotry counterparts and redeploy those inspection resources elsewhere.
The Pew report also emphasized the industry's own role in supply chain management and safety,
" There was strong agreement that manufacturers must be held accountable for their full supply chain and that they need to have concrete knowledge of suppliers when they are selected."
More sharing of information on suppliers among drug companies is also seen as a need to reduce supply chain risk.
Posted by Bruce Lehr July 14th 2011.
More on this story from the PharmaTech Talk blog
http://blog.pharmtech.com/2011/07/14/supply-chain-under-scrutiny/
Posted by: bigredbruce | 07/14/2011 at 05:38 PM