Regulators in the USA, Australia and the European Union are to work together in a bid to improve the inspection processes of manufacturing facilities around the world.
Michael Leavitt, Secretary of the US Department of Health and Human Services announced the programme at an ‘Import Safety Summit’ in Washington DC. It will see the HHS, the Food and Drug Administration and their counterparts in Europe and Australia “jointly plan, allocate for and conduct inspections of drug-manufacturing facilities”.
The project will initially focus on makers of active pharmaceutical ingredients and Sec Leavitt said that “working together, we intend to offer expedited access to those products shown to meet our standards and to focus more of our resources on those products that present higher risks”.
The HHS noted that the move was necessary because historically, the USA has primarily relied on intervening at the border to intercept unsafe goods. However, the collaboration comes at a time when that strategy was seen to fail miserably.
The issue of safety in facilities abroad has been under the spotlight since January 2007 when a number of deaths were reported that had been linked to contaminated versions of the blood-thinner heparin from China. The FDA has come under fire from a number of sources, but most vociferously from the US House Energy and Commerce Committee, which has accused the agency of not spending enough on inspections of drug manufacturers outside the USA to ensure the safety of medicine imports.
It is estimated that around 80% of active ingredients used by manufacturers in the USA are imported, and the FDA has been making moves recently to rectify the problem. A month ago, Mr Leavitt announced that the US government is planning to give the agency an extra $150 million in addition to its budget for 2009 to expand its reach beyond American borders. A week later the FDA said it hopes to open offices in three Chinese cities staffed with inspectors by the end of the year.
