Securing Our Drug Supply
Yesterday afternoon, the U.S. Senate unanimously passed H.R. 3204, the Drug Quality and Security Act (DQSA). After strong bipartisan work in both the House and the Senate, this landmark patient safety legislation awaits President Obama’s signature, which could come as soon as the end of this week. The Senate’s action comes only a short time after the U.S. House of Representatives passed the bill earlier this fall. Congratulations to both chambers for taking this long-anticipated and critical step forward in protecting patients from the perils of counterfeit medicines.
The first and perhaps most serious problem has been the lack of a uniform “track and trace” system for pharmaceutical products. While California has moved to implement just such a system (which has in turn become something of a de facto standard for all US companies due to California’s market share), legislators have been interested in implementing a national standard to avoid other states introducing competing ones.
The other hope, of course, is that the system will allow regulators to keep better track of the pharmaceutical supply chain, cutting down on counterfeiters and allowing them to respond more quickly to other problems as well.
The second problem, and the subject of numerous congressional hearings, has been the issue of drug compounding. Under federal law, pharmaceutical compounders are treated as separate entities from pharmaceutical manufacturers, and are allowed to operate under state—not federal or FDA —oversight. In late 2012, a massive outbreak of fungal meningitis caused by contaminated steroid injections caused legislators to re-evaluate that paradigm and seek out new regulatory options.
With the Drug Quality and Security Act, patients win big. This new legislation creates a track-and-trace system to replace the current patchwork system of regulations. By establishing a single, uniform and national pharmaceutical supply chain, DQSA can provide patients greater peace of mind regarding the safety, efficacy, and authenticity of their medicines. and represents exactly the kind of modern rules we need to help keep counterfeit medicines out of the supply chain.
