CONGRESSWOMAN ELISE STEFANIK
On Monday, June 3, 2013, the House will consider H.R. 1919, the Safeguarding America’s Pharmaceuticals Act of 2013, under a suspension of the rules. H.R. 1919 was introduced on May 9, 2013 by Representative Robert Latta (R-OH) and was referred to the Committee on Energy and Commerce, which reported the bill by voice vote.
H.R. 1919 secures America’s prescription drug supply chain from illegal counterfeit drugs by enacting a number of new provisions into law.
Section 2 establishes tracing requirements for manufacturers, wholesale distributors, pharmacies and repackagers. Each time there is a transaction down the supply chain, the seller is required to provide the buyer with a history of all prior owners, and starting five years after enactment, manufacturers will be required to serialize all prescription drugs. Further, it would require members of the supply chain to verify the legitimacy of the products and only transact with licensed or registered entities.
Section 3 requires the FDA to establish pilot projects to collaborate with stakeholders on how to move towards unit-level tracing requirements and requires the GAO and FDA to submit reports to Congress on unit-level traceability. This section also requires the FDA to issue proposed regulations on unit-level traceability by 2027.
Section 4 establishes national standards for wholesale distributors, while continuing state control of licensing and fee collection.
Section 5 establishes licensing standards for third-party logistics providers and authorizes the FDA to charge a user fee. This section does not, however, prevent a State from issuing its own third-party provider licenses.
Section 6 establishes penalties, Section 7 preempts State laws on tracing, and Section 8 allows for electronic labeling.
In recent years, counterfeit prescription drugs have become more prevalent as the market for illicit prescription drugs has become more lucrative. In response, some states have attempted to enact laws to secure the supply chain from counterfeit drugs. California, in particular, enacted a law requiring businesses to implement electronic systems for tracing prescription drugs at the unit-level. While well-intentioned, this requirement is extremely costly, currently infeasible for businesses, and has the potential to dramatically increase costs across the country.
H.R. 1919 preempts laws like the one in California and establishes a more comprehensive, national policy to secure the nation’s prescription drug supply chain. Instead of immediately requiring unit-level tracing requirements, which is extremely costly and difficult to achieve, H.R. 1919 establishes lot-level tracing requirements with the long term goal of unit-level tracing. It also establishes labeling safeguards to ensure that all members of the supply chain are informed of where a product has been and where it comes from.
 See “More Lucrative Than Cocaine: Fake Medicine on the Rise”, Wall Street Journal, February 13, 2013.
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