• Health reform
• EMRs
• Medicare
• Liability
• AMA House
• » More

• Contract Language
• Ethics Forum
• In the Courts
• Practice Management
• Technically Speaking
• » More

• Issue dates
• Regions
• Health plans
• Sections
• News briefs
• Columns
• Editorials
• Letters
• Series
• Writers
• Other years

• Search tips
• Email alert
• RSS
• Mobile
• Subscribe
• Institutions
• Staff directory
• Advertising
• Permissions
• Reprints
• News media
• Site guide
• Useful links
• About
• Premium
• Contact

• AMA Wire
• CPT
• DMPHP
• JAMA
• JAMA&Archives
• news@JAMA
• Virtual Mentor
• Physician jobs

Congress breathes new life into drug importation law

Narrow criteria for ordering medication from Canada are set in legislation that lawmakers hope will help meet FDA's safety concerns.

By Joel B. Finkelstein, amednews staff. July 14, 2003.

• PRINT|
• E-MAIL|
• RESPOND|
• REPRINTS|
• SHARE
•  

Washington -- The push to legalize the importation of drugs has gained new momentum as part of the effort to reform Medicare.

Legislation to allow U.S. patients to order prescription drugs from pharmacies in Canada would make these drugs available to individuals who could not otherwise afford them, proponents say.

Congress added importation amendments to the Medicare prescription drug bills that recently were passed by the House and Senate.

The price of prescription drugs has risen faster than other areas of health care over the past few years, said Rep. Dan Burton (R, Ind.). Currently, one in five adults cannot afford to buy some or all of his or her prescribed medicines, Burton said.

"Unless the high price of prescription drugs is brought down to a more manageable level, we face the very real possibility that more and more Americans will be forced to choose between purchasing their food and buying their prescription drugs," he said at a recent hearing on the subject.

During debate on the Senate floor, Sen. Debbie Stabenow (D, Mich.) said, "If we want to help folks right now, the way to do that is to give them the opportunity to get their prescription drugs at the lowest possible price."

Legislation sponsors say they are just trying to bring prescription drugs within the realm of free trade. However, some lawmakers and economic experts argue that Americans would be importing not only drugs but also price controls.

"In a sense, we are going to set prices in this country," said Sen. Rick Santorum (R, Pa.). "We are going to adopt the Canadian formula." Other developed countries that have national health care systems have ultimate negotiating power. For example, companies that fail to meet Canada's price demands can be shut out of the market, he said.

Santorum and others have argued that it is not that the United States pays too much for drugs but that other countries don't pay their fair share.

Price-controlled Canadian imports would undermine a system that has encouraged pharmaceutical companies to invest in the research needed to produce innovative products, testified Stephen Moore, senior fellow in economics at the Cato Institute, a Washington, D.C., think tank.

During the recent House hearing, Burton pulled out example after example showing that the cost of common prescription drugs is five to 10 times more in the U.S. market than in the European Union, Canada or Mexico.

Why pay more?

A persistent question in this debate is whether Americans should pay more than Canadians or anyone else in the developed world.

Representatives of the drug industry have explained that Americans are bearing the burden of the high cost of research and development.

But this is not the whole story, as the industry continues to have profit margins that complement their blockbuster products, despite a health care economy that is suffering overall, importation proponents point out.

While industry advocates blame high prices on the prohibitive cost of research, the actual cost to develop a drug remains a closely guarded secret.

"Ultimately, we are buying R&D with these high prices," said James Love, an economist at the Center for the Study of Responsive Law in Washington, D.C.

Santorum said U.S. citizens also are paying the added cost of more stringent regulations to ensure the safety of domestic medications.

The Dept. of Health and Human Services, under both the Clinton and Bush administrations, has refused to implement importation laws passed by Congress in previous years. HHS Secretary Tommy Thompson has stated that the Food and Drug Administration cannot ensure the safety and authenticity of drugs being brought back over the border.

Physician worries

In a letter to Congress, AMA Executive Vice President Michael D. Maves, MD, explained that the Association cannot support current importation bills based on statements from the FDA indicating the agency does not have the resources to oversee imported drugs.

"In light of the increased potential for acts of terrorism and bioterrorism, the break in the chain of regulatory control makes patient harm a real possibility," the letter states.

The current legislation attempts to address some of these safety concerns by limiting importation to drugs from Canada. The administration has not given any sign that this provision would change its stance against implementation.

However, an amendment attached to the House's agricultural appropriations package attempts to maneuver around this roadblock by barring the FDA from spending any money to prevent the importation of FDA-approved drugs from other countries.

Back to top

 ADDITIONAL INFORMATION: