The Senate, ignoring a White House veto threat, yesterday advanced a measure that permits the importation of less-costly prescription drugs from Canada and other countries.
Under the legislation, any imported drugs would have to be approved by the Food and Drug Administration, manufactured in facilities inspected by the FDA and have documentation about who has handled the drugs. The bill limits drug imports to 19 industrialized countries and would require the FDA to inspect Canadian prescription-drug exporters 12 times annually.
Sen. Byron L. Dorgan, North Dakota Democrat and the bill’s sponsor, has long advocated allowing importation of U.S.-made prescription drugs or drugs made abroad but federally approved into the United States.
His goal is to lower drug costs that have increased by more than 10 percent each of the past three years. The bill would save the federal government $50 billion over 10 years, which is not a significant amount. However consumers paying for expensive prescription drugs could save significant money.
“The fact is, we are paying the highest prices for brand-name prescription drugs in the world and that’s not fair,” Mr. Dorgan said. “Let’s make the global economy work for everybody.”
Opponents of drug reimportation, such as the pharmaceutical industry, say cheaper drugs are available in Canada because of government price controls and warn similar government intervention would result if drug reimportation were allowed.
Safety is another issue triggered in the drug reimportation debate. Mr. Dorgan has pressed for years to bring the bill to a vote, but opponents consistently parried his effort on the basis that reimported drugs are not safe. President Clinton’s administration did not support reimporting prescription drugs.
Lawmakers in the Senate voted 63-28 to limit debate on the bill and move to a final vote on adding the provision to a larger bill about the oversight of drug safety by the Food and Drug Administration. A final vote on the bill is expected today or early next week. The House has yet to take up the FDA bill, but the drug-importation provision should not be a stumbling block now that Democrats control that chamber.
But Sen. Thad Cochran, Mississippi Republican, threw up a hurdle immediately after the vote. He proposed an amendment to require the government certify the safety of imported drugs and whether importation would save money.
Mr. Cochran’s amendment has yet to be voted on but, if passed, would undercut the effects of Mr. Dorgan’s bill because the Bush administration is unlikely to certify the safety of imported drugs.
Mr. Dorgan’s bill would implement an approval standard for foreign-made drugs in which the manufacturer notifies the FDA of differences between the drug and the corresponding U.S. label.
Mr. Cochran’s bill would give the administration more leeway to decide whether the drug is safe and cost-effective.
The White House has threatened a veto if Mr. Dorgan’s amendment is included in the FDA legislation, but White House spokesman Tony Fratto said a veto will not be necessary if Mr. Cochran’s bill is included.
“We support the Cochran amendment. It sufficiently alleviates our safety concerns caused by the Dorgan amendment,” Mr. Fratto said.
Though illegal under federal law, the practice of importing prescription drugs is widely engaged in by U.S. citizens living in states that border on Canada. Many states, including Virginia and Maryland, introduced bills that would have created prescription-drug reimportation. However, primarily because it would instigate federal intervention, none has been signed into law.
Montgomery County, which is home to the FDA, last year filed a lawsuit against the agency to force the agency to issue a federal waiver to allow a prescription-drug reimportation program for county employees.
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