Speaking at the European Union Health Minister Forum this week in Angers, Anjou, France, Michael Leavitt, Secretary of the US Department of Health and Human Services and chair of the Interagency Working Group on Import Safety, pointed to a pilot program for joint inspections between the United States, the European Commission, and Australia, He called the program “the beginning of what we hope will become a new way of doing business.” HHS launched the pilot program in July. Under the program, HHS, with its counterparts in the European Union and Australia, will jointly plan, allocate for, and conduct inspections of drug-manufacturing facilities. Each agency will share the task of conducting inspections and sharing that information with their counterparts, “so each of our regulatory agencies can make the best decision on approvals for our individual markets,” said Leavitt this week. The project is initially focusing on makers of active pharmaceutical ingredients. If successful, the program could expand to include other types of manufacturing facilities.

Leavitt says the program embodies the principle of “collaborative information-gathering with individual decision-making,” adding, “through this new collaboration, we can spread our inspection net wider by leveraging our respective resources.”

Although any effort to increase the level and frequency of inspections of foreign drug-manufacturing facilities using more efficient resource allocation is certainly laudable, it is important not to lose sight of the larger problem in the inspection process of foreign drug-manufacturing facilities, namely the inspection of facilities in China and India.

According to a report issued by the US Government Accountability Office earlier this year, Canada, China, France, Germany, India, Italy, Japan, and the United Kingdom were the foreign countries with the largest number of registered drug establishments in fiscal year 2007. China had more establishments manufacturing drugs that were offered for entry into the United States than any other country.

However, only a portion of the drug establishments in India and China were inspected by the US Food and Drug Administration in fiscal years 2002–2007. In China, for example, only 11%, or 80 of 714 drug establishments were inspected by FDA during this time. India fares somewhat better with 37%, or 152 facilities inspected of a a total of 410 drug establishments.

FDA is making efforts to improve foreign inspections by gaining more funding and staff, opening up satellite offices, and planning to improve its information technology systems, which now do not accurately identify the number of foreign drug-manufacturing facilities, according to the GAO report.

These steps are a beginning, but it is important to recognize the unique challenges and efforts, both operational and economic, which will be needed to bring all players in the global pharmaceutical supply chain to common standards.