Senate Committee Hears Testimony Regarding Securing the US Drug Supply Chain

September 23, 2011 9:45 am

Securing the pharmaceutical supply chain from vulnerabilities related to the complex global supply chain was the focus of a United States Senate Committee on Health Education Labor and Pensions hearing held September 14, 2011. Deborah Autor, JD, deputy commissioner for global regulatory operations and policy, Food and Drug Administration (FDA), provided witness testimony, pointing out that 40% of pharmaceuticals in the US supply chain are made outside of the US, and 80% of active ingredients used in US-made products come from more than 150 countries. Autor noted further that with the increase in supply chain complexity, “authorities have not kept pace with the challenges of the current global marketplace” and that “these factors create great challenges to FDA and industry in ensuring that all drugs are high quality and travel safely throughout their complex supply chains.” Autor outlined the increased authorities for FDA that could help to ensure greater security and safety for drugs entering the US. Video clips of the hearing and links to witness testimony are available on the Senate committee’s Web site.