USA/EU/Australia unite on drug safety scheme

US Health and Human Services Secretary, Michael Leavitt, has announced two "groundbreaking programs" designed to enhance the safety of imported food and drugs. The first is a pilot project involving the Food and Drug Administration and its Australian and European Union counterparts, the European Medicines Agency (EMEA) and the Therapeutic Goods Administration, respectively. This involves sharing inspections of drug production sites, initially focusing on active pharmaceutical ingredients. The second concerns food safety.

Mr Leavitt made the announcement at an inter-industry summit on import safety, which was sponsored by 13 US trade associations, including the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America (PhRMA), in Washington, DC (Marketletter July 7). He described the twin initiatives as the latest steps in a federal government's Interagency Import Safety Action Plan finalized in November 2007. Historically, Mr Leavitt explained, US authorities have primarily relied on intervening at the border to intercept unsafe goods. The new strategy calls for working with trading partners to help ensure they build quality into every step of a product's life cycle.