It still did not have a complete and reliable list of foreign factories making drugs that end up in American bloodstreams. "FDA does not know how many foreign establishments are subject to inspection," Crosse told the committee.
One FDA list said about 3,000; another, 6,800. A third list of foreign facilities that FDA "prioritized" for inspections cited 3,249. Of these, says GAO, FDA inspects about 7 percent a year, meaning it would take 13 years to inspect them all.
In the People's Republic of China, according to GAO, there are now 714 drug-making facilities on FDA's "prioritized" list. From 2002-2007, FDA inspected only 88 of these, and the number of inspections has been declining each year. In 2005, it inspected 21 Chinese plants; in 2006, 17; in 2007, 13.
Double standards persist. Here, FDA inspections are unannounced. In China, FDA inspectors warn the drug maker in advance and must get a visa.
Most remarkably, the FDA does not bring its own translators on foreign inspection tours or hire independent translators to accompany its inspectors to foreign drug-making facilities. Instead, it relies on English-speaking officials at the factories being inspected to tell them what is going on.
"Our concern is not whether there is somebody in the Chinese facility who speaks English," GAO's Crosse told me, "but whether the inspectors can to talk to anybody on the line that they want to, can look at the signs labeling the equipment and read it and understand whether it is appropriately labeled, whether it has the right kinds of warnings on it, can look in a logbook and understand what kind of records were being kept, and understand what the columns were that people were asked to fill out."
The heparin that is suspected in the four deaths over the last two months was sold by Illinois-based Baxter Healthcare Corp., which secured the active ingredient in the drug from a company in China called Changzhou SPL. Changzhou was never inspected by the FDA, the Chicago Tribune reported this week, because "regulators confused the factory's name with another that already had U.S. approval."
"This is exactly the risk we were pointing to," Crosse told me.
Will another decade pass before politicians fix the FDA?