Lax U.S. drug import regime may offer opening to al-Qaeda
or testing, Nissen said. At the same time, the U.S. agency responsible for protecting the food and medicine supply maintains a very small monitoring presence abroad. The FDA has roughly 800 investigators trained to conduct foreign inspections, but critics say the available personnel cannot keep up with the vast growth in consumable imports. “Amazingly, unless invited by the foreign government, the FDA lacks the authority to inspect the foreign food processors, even when investigating outbreaks of illness linked to the country,” Nissen said during a speech in Cleveland on Monday. “Additionally, the FDA does not require that imported foods be produced under conditions equivalent to U.S. food safety systems.”
The challenge for the United States is global, but Nissen is especially concerned about Chinese imports, he said in the interview the next day. “In 2006 and 2007, the FDA did not conduct a single inspection of a Chinese food importer — zero,” Nissen said. “I want to make sure that we understand when we import drugs and food from overseas, where we are not supervising the manufacture of those drugs or food, that there are real risks involved.”
Some national security experts believe that such characterizations of the terrorist threat are overblown. According to this view, one reason why terrorists have not already penetrated the imported food or medicine supply is that the hurdles to doing so — even abroad — remain enormous. There are many more likely scenarios that terrorists might embrace for harming U.S. citizens than attempting to operate undetected in a food or drug export business in a nation such as China, skeptics say.
Nissen conceded that profit-driven or accidental lapses in the quality of foreign-source food are clearly more likely to occur. He noted, though, that bolstering prevention would help protect the U.S. public from contaminated imports, regardless of a producer’s intent. Nonetheless, the terrorist threat remains real, he said. “There are people out there that want to harm Americans. And they will go to great lengths to do so,” Nissen said. “We have to protect ourselves.”
Andrew von Eschenbach, who resigned his post as FDA commissioner on 20 January, last year acknowledged that his agency had not yet fully adapted to globalization. Concerning medicine imports, “FDA must further shift from ‘gate-keeper’ to a stronger and more comprehensive import safety authority,” he said last April in testimony before the House Energy and Commerce Oversight and Investigations Subcommittee. “Imported drugs and devices must be safe and effective and must meet all applicable FDA standards prior to reaching U.S. ports-of-entry.” The commissioner described implementation of the Bush administration’s “Action Plan for Import Safety,” released in November 2007, as “only a start” toward protecting U.S. consumables. “The agency will learn and adapt as we move%
