- The Washington Times - Tuesday, July 16, 2002

Legislation allowing re-importation of U.S.-made drugs from abroad could open the floodgates to adulterated and often dangerous counterfeit drugs from unscrupulous profiteers, deranged individuals and even terrorists.

Not even trained professionals can spot the negligible differences between many of today's counterfeits and the real thing. Often, laboratory testing of the actual ingredients is necessary to determine which are fake and which are genuine.

Counterfeits manufactured at laboratories in China, Thailand and other Asian nations are so good, in fact, that they appear to be identical with popular American drugs such as Nupogen, a cancer medicine and Viagra right down to the bar codes and inventory numbers on the packaging.

As an FBI agent for more than 27 years, I am aware of operations, in which counterfeit prescription drugs were seized.

In a number of cases, the smuggled counterfeit drugs contained no active ingredients, but were merely sugar or starch. In some cases, actual American drugs were being re-imported after their expiration dates had expired.

Some of the drugs confiscated were formulated to come close to the genuine prescription of the American-made ones they copied, but few were exact copies. And it's likely they were not manufactured under the squeaky-clean sterile conditions present in American pharmaceutical factories.

When you're treating a serious illness or medical condition, any physician will tell you that close is simply not good enough, and quite often can be extremely risky to a patient's health. They'll also tell you even exact-copy drugs are dangerous unless they're produced in a completely hygienic setting.

"Without our domestic safety net to ensure the integrity of these pharmaceuticals, consumers simply do not know what medicine they are buying," observes Sen. John Breaux, one of the leading health care legislators in Congress.

During my three decades with the FBI, however, I worked with other federal agencies whose main goal was preventing illegal narcotics from crossing our borders. When going after prescription-drug shipments, it usually was large quantities and mostly acting on tips.

Neither we, nor the three federal agencies we cooperated with on such efforts the U.S. Food and Drug Administration, the Drug Enforcement Administration and the Customs Service had enough personnel to go after prescription- drug smuggling at that time.

With the massive new threat of terrorism that emerged September 11, we have even fewer resources to devote to such activities. Legislation permitting re-importation would exacerbate the problem on an exponential scale.

As William Hubbard, a senior associate commissioner for the FDA, noted at a recent Senate hearing: "Throwing the door open to drugs purchased by individuals directly from Canadian sellers will encourage unscrupulous individuals to devise schemes using Canada as a trans-shipment point for dangerous product from all points around the globe."

He's right. Even after September 11, our 3,924 miles of contiguous border with Canada remain extremely porous. So does our 2,066 mile-long-border with Mexico, where counterfeit drugs could flow unabated into this country with each nightly wave of illegal immigrants.

Equally disconcerting is the possibility that a deranged person like the Unabomber also might take advantage of a re-import law to randomly distribute poisoned prescription drugs to seniors in the United States.

That may sound far-fetched, but after Ted Kaczynski and September 11 nothing should be ruled out.

Since 1995, I've advised clients on security measures they can take to thwart the illegal activities of all sorts of criminal-types, including terrorists.

My advice to the 100 members of the Senate and the 435 members of the House of Representatives on allowing re-imported drugs is pretty straight-forward: Don't risk it.

Anthony E. Daniels is the CEO of Manual, Daniels Burke International, a private investigating and consulting firm.

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