The globe may just be too big for U.S. drug watchdogs to cover alone. Regulators are teaming up with Europe and Australia to inspect factories in China and India, in a pilot program designed to see whether cooperation might allow them to cover more territory and keep an eye on more foreign facilities. "What we are seeing is the maturing of a global market, and we have to invent new tools to deal with a changing environment," HHS Secretary Michael Leavitt said in announcing the deal.
The program will focus its attention mostly on facilities in countries outside the regulators' own territories. For instance, China and India, which produce an overwhelming amount of raw materials for the world's pharmaceuticals. As we all know from the big heparin debacle early this year--and from the red tape U.S. officials have had to contend with since to open on-the-ground inspection offices in China--those production facilities can lie beyond the reach of U.S. watchdogs.
Under the new program, the three partners would share information and inspection schedules to avoid duplicating their efforts and to identify potential problems faster. So we'll see if three heads really are better than one.
- read the Associated Press story