Pause for prescription safety

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Earlier this week, Senate Majority Leader Bill Frist announced that it would be unlikely for the chamber to take up prescription drug reimportation before the fall. That pause does not, by itself, represent a defeat for the bill, but it does represent a hopeful sign that the body will reconsider its decision to allow unsafe drugs into the country.

Lawmakers have continuously clamored for the legal importation of drugs from Canada and other nations. The battle royal began during the fight over the prescription-drug provision in the Medicare bill in the House last summer. Legislation allowing reimportation passed the House, but was dropped from the Medicare conference report. This week, a provision allowing the importation of prescription drugs was approved as part of the appropriations bill for the Food and Drug Administration (FDA) and the Agriculture Department, but is likely to be stripped out later. Mr. Frist has said that he would allow the debate in the Senate to follow its normal course through committee, but has insisted that legislators agree on a safety standard. To date, they have not done so.

There is no doubt that reimporting drugs without safety standards is tantamount to risking lives. At Senate hearings in May, Food and Drug Administration (FDA) officials testified that reimportation would bring with it a high risk of counterfeit and contaminated medicines. Without safety certification, there will be no control over whether reimported medicines will be composed of carefully constructed molecules or snake oil and sugar water.

Reimporting pharmaceuticals also endangers the very process that made them. Profits from the few medicines that are successful make up for the many that are not, and fuel research into new ones. Last year, U.S. members of the Pharmaceutical Research and Manufacturers of America spent over $33 billion on the research and development of new medicines.

Backers of reimportation claim that drugs cost less in Canada, but they ignore its socialized system of medicine. They claim that reimportation is a question of free trade, but ignore how foreign governments de facto blackmail U.S. corporations into low prices by threatening to accept foreign substitutes. While subtle, the price of such "free" medicines is substantial: Patent protections are undermined, pharmaceuticals are delayed or never developed and patients are endangered.

The AARP is now pushing for Congress to pass a drug reimportation bill. Political considerations cannot be ignored, but legislators looking to bring home credentials of their care and action can do better than a bill that endangers their constituents. Mr. Frist and his fellow senators should pause for as long as necessary to be sure that any drug-reimportation bill has sufficient safeguards for both the research community and U.S. citizens.