Senator Says Hamburg Not Aggressive Enough on Supply Chain
Sen. Sherrod Brown (D-Ohio) had harsh criticism for FDA Commissioner Margaret Hamburg recently, questioning the agency’s lack of enforcement actions against companies’ with holes in their supply chain knowledge.
The questions, which came during a Senate Appropriations subcommittee hearing on the FDA’s fiscal 2013 budget request, attacked the agency’s position on why it doesn’t hold companies more responsible for knowledge of their products’ supply chain.
“If a CEO is not certain where all the ingredients come from, and those ingredients coming from wherever end up killing a patient in Toledo, shouldn’t that CEO go to jail? Shouldn’t that company be fined huge amounts of money?” Brown asked. “I want these companies to be responsible for their ingredients.”
Pointing to the oft-cited example of the tainted Chinese heparin outbreak, Brown called on the agency to force drug manufacturers to be more responsible for their imported products.
Lawmakers are not alone in pressing for greater drugmaker accountability. The FDA has already handed out warning letters for insufficient supply chain knowledge and inadequate supplier agreements.
To avoid such letters, it’s no longer enough to have purchasing agreements with shippers that make passing reference to quality contracts. You need ironclad supply chain quality agreements.
But what does a good quality agreement look like? How do you negotiate it with warehouses, wholesalers and shippers? And, then, how do you document compliance?
Here are the answers you need to “FDA-proof” your entire supply chain. An essential new management report from FDAnews, Warehousing and Shipping Supply Chain Quality Agreements: Key Considerations for Pharmaceutical Companies, explains the regulatory supply chain requirements that govern pharmaceutical warehousing and transport.