WASHINGTON -- Scant monitoring of expanding U.S. food and medicine imports could heighten the risk of biological attack by al-Qaeda or other terrorist groups, according to a leading drug-industry watchdog (see GSN, Jan. 21).
(Jan. 29) -
Chinese workers inspect pharmaceutical containers in 2006 (China Photos/Getty Images).
Over the past two years, reports of tainted ingredients in powdered milk, blood-thinner medication and pet foods manufactured in China have underscored the perils of globalization for U.S. public health, said Steven Nissen, a Cleveland Clinic cardiologist.
Chairman of the hospital's cardiovascular medicine department, Nissen is said to be in contention to become head of the Food and Drug Administration in the Obama administration. The former president of the American College of Cardiology sounded early alarms about heart attack risks related to the painkillers Vioxx and Celebrex; he also led an effort to block an emerging diabetes drug, Avandia, because of similar concerns.
Thus far, repeat incidents of contaminated foreign foods and medicines appear to reflect a drive to reduce production costs in poorly regulated nations, rather than an intention to harm consumers, Nissen said during a Tuesday telephone interview.
However, the Food and Drug Administration has exerted insufficient control over the quality and content of imported food and drugs, he asserted. Terrorist leaders could easily identify and exploit this key U.S. vulnerability, Nissen said.
"If you were al-Qaeda and you wanted to harm Americans, you're not going to go try to hijack a plane and then fly it into a building again," Nissen told Global Security Newswire. "But if you could get access to a plant in China that makes pharmaceuticals and put something into those [drugs] that is hard to detect, I believe you could put Americans at great risk."
Until recently, Nissen has not spoken out about his concerns regarding a terrorist risk to the food and drug supply.
"I'm not interested in giving al-Qaeda any ideas," he said. "But, on the other hand, burying our heads in the sand, as we did before 9/11, isn't necessarily the right thing to do. ... There are certain areas where we are very vulnerable, and I happen to think this is one of them."
The United States is particularly dependent on foreign nations for foodstuffs, he noted. Eighty percent of seafood and nearly half of the fresh fruits consumed in this country come from abroad. Much of it clears customs based on electronic data provided by the importer, without any U.S. sampling or testing, Nissen said.
At the same time, the U.S. agency charged with protecting the food and medicine supply maintains a very small monitoring presence abroad. The Food and Drug Administration 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."
While the challenge for the United States is global, Nissen is particularly 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 Jan. 20, 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 forward as part of the larger, ongoing agency transformation into an FDA of the 21st century," von Eschenbach said. Still, he added, "even with the challenges presented by globalization, the American product supply for drugs and devices continues to be among the safest in the world."
The Food and Drug Administration conducted 498 inspections of foreign prescription drug-manufacturing plants in fiscal 2007, more than any other year in its history, von Eschenbach testified. In order to enhance import safety, the agency also has concluded 70 cooperative arrangements with its counterparts abroad and another 30 information-sharing agreements that allow for the exchange of inspection data, he said.
During fiscal 2008, the agency invested $13 million in an effort to "improve its ability to integrate and assimilate risk-based information into data systems [and] detect signals of intentional and unintentional food contamination," among other efforts, FDA Associate Commissioner for Foods David Acheson testified before the same committee in September.
Nissen said existing FDA initiatives to partner with foreign nations offer a good start toward more assertive monitoring of the food and drug supply, but he would like to see more done.
As the most urgent next steps to be taken, "I'd say increase dramatically the on-site inspections of foreign manufacturers and do much more testing and sampling of things being imported into the U.S.," he told GSN.
"We've got to do a better job of on-the-ground surveillance. That means we've got to be there in those countries," he said. "We've got to demand cooperation from the local authorities. I think we also have to do a lot more spot inspections and testing of what comes in."
Nissen has called for a doubling of the "desperately underfunded" budget at the Food and Drug Administration, which currently regulates $1.5 trillion in products with a $2.4 billion annual spending plan. He acknowledged that any such funding boost might remain on the back burner as the nation grapples with a financial recession and skyrocketing budget deficit.
However, the FDA watchdog said he sees broad support on Capitol Hill for reinvigorating the agency and strengthening its hand. One initiative attracting interest could be legislation to require full ingredient disclosure on imported prescription drug labels, Nissen said.
"We have to realize that globalization is here to stay; that food and drugs are now a global marketplace; that if we're going to then operate in that global marketplace, we have to have the checks and balances in place to make sure we're doing a good job of protecting the public," he said.