US FDA inspectors to be based abroad

The US Food and Drug Administration has announced plans to maintain inspectors on permanent postings in several developing countries with drug manufacturing sites. The agency's Commissioner, Andrew von Eschenbach, told the New York Times that the present arrangements are inadequate for the task of monitoring the quality of drug production sites in China and India, as well as in several Latin American and Middle East nations.

Instead of bringing inspectors into a country on an ad hoc basis, Dr von Eschenbach said he wants "boots on the ground." A major factor in the shift of emphasis for the FDA is recognition of the growing importance of imported drugs. With drug re-importation being favored by all the likely Democratic party's presidential candidates and Senator John McCain (Arizona), one of the leading Republican options (Marketletter January 21), the security of distribution channels is of potentially-growing significance to US regulators.

FDA working with China and India