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US: Consumer Drug Imports Weaken Safety System

Consumer Drug Imports Would Weaken Safety System, U.S. Says

Drug regulator warns Congress about dangers of counterfeit drugs

By Andrzej Zwaniecki
Washington File Staff Writer

Washington -- Proposed legislation to allow importation of pharmaceuticals by individual U.S. consumers would weaken the proven regulatory system that ensures safety of the U.S. drug supply, a Food and Drug Administration (FDA) official says.

In September 20 remarks, FDA Deputy Commissioner Scott Gottlieb said that under proposed legislation the import of prescription drugs through middlemen, storefront pharmacies and foreign Internet sites would represent a “new and gaping hole” in FDA controls.

“No amount of well-intentioned legislation to apply a safe way to check the drugs coming in through these different importation schemes is going to fully guarantee their [drugs’] safety,” he told an international symposium in Washington on drug counterfeiting.

Some individual Americans, as well as some U.S. local governments, stung by the accelerating costs of pharmaceuticals, have been buying medicines in foreign countries, mostly in Canada.

In many of those countries, governments keep drug costs down by imposing price controls on pharmaceuticals or controlling their prices in other ways. In the United States, where drug prices mostly are set by the market, those prices are among the highest in the world.

Gottlieb said the channels used by U.S. consumers to import pharmaceuticals also are being exploited by drug counterfeiters and other criminals. Counterfeited drugs might be contaminated or might contain incorrect ingredients or improper dosages and, as such, not work as intended or even harm the patients, he said.

Gottlieb said that not only are flows of counterfeit drugs around the world increasing but so are the skills and technological capabilities of counterfeiters.

He said that the number of counterfeit drug cases handled by his agency has jumped to 58 in 2004 from six in 2000.

Legislators promoting and supporting drug importation measures, Gottlieb said, must consider “how much safety you want to demand and how many corners you are willing to cut.”

Measures to allow drug importation from Canada and Europe have been introduced in Congress but never have been enacted into law because both the Clinton and current Bush administrations argued that the safety of drug imports could not be guaranteed.

The American Association of Retired Persons (AARP) has disputed the administration position. A report it published in July said that importation of lower-priced medicines from countries in southern Europe to more affluent Western European countries had lowered costs without compromising safety or disrupting supplies.

Pressure from voters and interest groups such as AARP has re-energized congressional efforts aimed at making importation of medicines legal in the United States.

Lawmakers either have sponsored separate drug import bills or attached drug import amendments to unrelated legislation. For example, the full Senate was scheduled to debate on September 20 such an amendment to an Agriculture Department funding bill.

The White House issued a statement September 19 saying that President Bush would veto the appropriations bill if it contains provisions relaxing curbs on drug imports or easing the trade embargo against Cuba.

The full text of Gottlieb's prepared remarks is available on the FDA Web site.

(The Washington File is a product of the Bureau of International Information Programs, U.S. Department of State. Web site:

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