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Mr. PALLONE. Mr. Speaker, 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. 1919 sets national standards for the licensing of wholesale distributors, I am concerned that these standards preempt all state laws, effectively preventing states from having stronger licensing standards if they deem it necessary in their unique circumstance. National licensing standards should act as a floor defining what states must require, not as a floor and a ceiling.
I am also concerned that if H.R. 1919 becomes law, there will be a significant gap in the current level of information about a drug's path through the supply chain. H.R. 1919 preempts all state requirements regarding drug tracing on the date of enactment, but the new federal standards do not go into effect until 2015. This leaves a potentially-long window open for counterfeit or substandard products to enter the supply chain and reach customers.
It is crucial that if we are going to preempt state efforts, we must have a strong federal standard. This standard should serve as a true building block to tracking drugs at the unit level, so that each and every product is authenticated at the lowest unit of sale before they reach patients, and counterfeit or contaminated products are kept out of the drug supply chain or quickly eliminated from it. Unfortunately, H.R. 1919 does not meet these goals.
While I do not want to stop this process from moving forward, I remain concerned about the provisions in H.R. 1919 and look forward to conference with the Senate to strengthen the bill and, ultimately, enacting legislation that will truly protect the nation's drug supply.
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