Apr 26, 2013
Project: Drug Safety Project
Dear Chairman Harkin, Ranking Member Alexander, Senator Bennet, and Senator Burr,
Thank you for the opportunity to comment on this draft proposal to secure drug distribution in the United States. We commend your continued bipartisan efforts on this important issue.
Counterfeiting and drug diversion, while thankfully far less common in the U.S. than in other parts of the world, remain matters of serious concern. The United States lacks strong baseline standards for licensure of pharmaceutical wholesalers, and we lack a standard system for companies to keep track of our pharmaceuticals during distribution. There is currently no way to check whether an individual vial or bottle is authentic or counterfeit. Despite the strength of laws in states such as California, multiple state requirements on drug traceability are not ideal either for companies or for consumers. The United States lags behind other countries that have already put in place serialization and verification requirements.
Pharmaceutical manufacturers are already making investments in drug serialization technology. To justify the expense – and the preemption of strong state laws – it is essential that any federal law achieve the following within a reasonable time frame: