FDA Worried About “Round-Trip” Drug Imports From Canada

By Joe Fiorill
Global Security Newswire

WASHINGTON — Amid increasing controversy in the United States about high prescription drug prices and a related increase in illegal drug imports, the U.S. Food and Drug Administration believes there is a “real risk” of a terrorist attack on the country conducted through the drug supply, a top FDA official said this morning.

Delivering a keynote address at Harvard University’s BioSecurity 2003 conference here, FDA Deputy Commissioner Lester Crawford said that with Americans “madly scrambling” to obtain medicine at lower prices, terrorists are likely to consider attacking the United States by contaminating imported drugs, from Canada in particular.

The battle over whether the United States should alter its laws and policies on importing drugs is now being played out in congressional talks on Medicare drug benefits and in other venues. States such as Minnesota, Illinois and Massachusetts have been seeking to import more drugs, and members of Congress including Senator Edward Kennedy (D-Mass.) have called on the FDA to set up safeguards for importing drugs from Canada.

Crawford told Global Security Newswire after his speech that he is particularly concerned about U.S. drugs sold to Canadian firms and reimported into the United States, since Canada has limited regulatory authority over such drugs.

Asked what the FDA hopes will result from the current flux in U.S. drug import policy, Crawford took a law-and-order approach.

“What we’d like to see is that they [U.S. buyers] not reimport. It’s against the law … and we are actively cutting them off,” he said.

Some U.S. lawmakers, however, are trying to change federal law in a bid to make less-expensive Canadian drugs available to their constituents and, ultimately, to use competition to bring down prices in the United States.

“We get about 30 to 40 percent of our fruits and vegetables from other countries. When they talk about contaminated drugs, it would be far easier for terrorists or anyone else to contaminate our food supply,” Representative Gil Gutknecht (R-Minn.), a leader in the effort, said earlier this month at a panel discussion on the controversy.

Gutknecht alleged the FDA is more interested in propping up prices for U.S. drug firms than in furthering public health.

“This is not about safety. It’s about money.  It’s about price,” he said.

Despite his concern about “round-trip” medicines, Crawford played down one drug industry concern: the possibility that allegedly lax Canadian immigration procedures could encourage terrorists to mount an attack on the U.S. drug supply from Canada.

“They have better border protection than they used to have,” Crawford said.

Crawford said the FDA is in the process of reinventing itself in the wake of the September 2001 attacks on the United States, with a special focus on the potential for a bioterrorist attack on the country. He concurred with Gutknecht that the food supply is vulnerable.

“After 9/11,” he said, “most of us believe that the next real possibility of a terrorist attack is through the food supply.”

He said planning for terrorism is now part of many FDA activities from which it was previously absent. “We look at food safety events as being possible terrorist acts,” said Crawford, calling nonterrorism-related incidents useful “rehearsals” ahead of a potential attack.

“We are very much in the business of terrorism, and in order to do that, we needed to change the culture of FDA,” he added, citing a “reorientation of not only the field force but the people at headquarters.”

One thing the FDA has not succeeded in developing after the 2001 attacks is a costly new “research agenda” to counter terrorism, Crawford said.

“The big thing that I can’t stand before you and tell you that we are ready for is a research agenda,” he said. The agency needs “some funding,” “the development of true experts” and “a body of scientific knowledge” in this regard, according to Crawford.

“And if we don’t do it here in the United States, then nobody is going to do it,” he said.

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