Reimportation Is Against The Law - And For Good Reason

ALEXANDRIA, Va. -- The U.S. Food and Drug Administration is cracking down on companies that aid Americans in illegally purchasing cheap prescription drugs from Canada via the Internet.

Canadian drug prices tend to be lower because of rigid government-imposed price controls that mean our neighbors to the north are not paying their fair share for drug research and development costs. But re-shipping drugs back into the United States from Canada is against the law - and for good reason.

There's no guarantee that the medicines that some 35 Canadian Internet vendors are shipping to Americans are safe or genuine. They could be out-dated, contaminated, counterfeit, or contain too much or too little of the active ingredient.

The FDA is charged with assuring the safety of prescription drugs consumed within America's borders, and it has repeatedly warned that it cannot assure that re-imports meet its exacting standards.

Now, even Canadian authorities are issuing warnings.

The Canadian National Association of Pharmacy Regulatory Authorities recently signed a joint statement with its U.S. counterpart saying that those who "facilitate prescription drug importation for United States consumers are encouraging the violation of federal and state laws in the United States that are designed to protect the health and safety of its citizens."

The statement says the "international movement of prescription drugs between Canada and the United States undermines the regulatory systems established in each country to protect consumers."

The FDA will target insurers like UnitedHealth Group, which is affiliated with AARP - formerly known as the American Association of Retired Persons. Under a contract, UnitedHealth reimburses AARP subscribers who purchase drugs via the Internet from Canada.

The FDA also has sent a letter to Rx Depot, an Oklahoma company that sends U.S. prescriptions to Canadian pharmacies to fill, saying the company is "exposing the public to the significant potential risks associated with unregulated imported prescription medications and misrepresenting them as being FDA-approved."

While the FDA is quick to point out that it will not go after individuals, consumers should think seriously before taking a chance.

In cracking down on imports, the FDA is only doing its job. It is enforcing a U.S. law passed in 1988 to protect Americans from fake and contaminated imported medicines.

Congress attempted in 2000 to legalize reimportation, but met a firestorm of opposition from former FDA commissioners and Secretaries of Health and Human Services who served during both Republican and Democratic administrations.

They warned that the U.S. government couldn't possibly monitor every package of pills entering the U.S.

Black market rings inevitably spring up with swindlers and impostors entering the market, and the FDA needs to concentrate its resources on tracking down these modern-day drug dealers - not monitoring shipments of Celebrex to grandma in Omaha.

Seniors should worry that they would be taking little blue or purple or green pills with no one assuring them they are safe or even that they are getting the medicine they need.

The Canadian government recently said that it will try to guard the safety and quality of the flow of prescription drugs across the border into the U.S., but both American and Canadian pharmacists believe that is an empty promise.

The president of the Canadian Medical Association, Dana Hanson, has said: "We feel Internet pharmacies could jeopardize patient safety, and we're against them."

Larry Kocot of the National Association of Chain Drug Stores in the U.S. said that consumers could be lulled "into thinking that Canadian drugs are as safe as American ones. We believe they're not."

For example, the U.S. sends its own inspectors to pharmaceutical factories in nations such as China and India to enforce its rigorous manufacturing specifications before certifying the drugs for U.S. consumption. The Canadian government accepts those countries' own certifications.

If U.S. citizens were injured consuming drugs re-imported from Canada, there's no doubt that trial lawyers would quickly file class-action lawsuits against the original manufacturers -- contending they must bear responsibility because they were aware their products were being shipped back to the United States illegally. Lawsuits already have been filed in cases involving re-imported drugs from Mexico.

Because of the huge safety risks, re-importing drugs is not a wise solution. What seniors need is an improved Medicare program that includes prescription drug coverage.

Congress has the issue on the front burner this year, with the leadership is hoping to pass a bill providing a Medicare drug benefit this summer. The solution lies not in breaking the law but in providing financial help to seniors who need it.