Frank Pallone: “Drug distribution security is critical to public health and safety, and I strongly support taking steps to ensure that…”

“Drug distribution security is critical to public health and safety, and I strongly support taking steps to ensure that the final pharmaceutical products patients receive are safe and effective. Although the bill before us today, H.R. 1919, the ``Safeguarding America's Pharmaceuticals Act,'' is well-intentioned, I have a number of concerns and believe the bill must be strengthened before it becomes law in order to truly protect the American people. There is widespread agreement that the best way to protect the supply chain is to establish a unit-level, interoperable system that involves all members of the supply chain. However, under H.R. 1919, there is no assurance that an effective system for tracking and tracing drugs will ultimately be put into place. The bill only calls on FDA to issue proposed regulations--there is no requirement for final regulations. In order to protect the drug supply chain, it is also important to ensure that unused drugs that are returned to the previous supplier and then re-enter the supply chain are just as safe as drugs going through the chain for the first time. I am concerned that the provisions in H.R. 1919, which allow the wholesaler to begin a new transaction history when it sells a returned product, create the potential for entry of illegitimate product into the system. While I am pleased that H.R.…”