Senate OKs the Import of Low-Cost Medicines

As part of the growing effort to cut prescription drug prices in the United States, the Senate approved a measure Friday that would allow pharmacists and pharmaceutical wholesalers to import lower-cost medicine from Canada.

The measure, added as an amendment to a Medicare reform bill under debate, could be blocked by the House or the Bush administration. Similar efforts have died in recent years, amid concerns from officials in Democratic and Republican administrations about the safety of imported drugs.

Still, Friday’s vote reflected the pressure on lawmakers to answer constituent complaints about the high price of medicine. Many Americans flock to Canada to buy pills they can’t afford at home. Others, far removed from the northern border, shop for drugs in Mexico or do without.

The amendment would let licensed U.S. pharmacists and wholesale distributors import drugs from Canada -- and presumably pass along savings to consumers -- during a one-year trial program. The proposal passed easily in the closely divided Senate, 62 to 28, a sign of the bipartisan push to lower drug costs.

The vote followed the Senate’s approval Thursday of a plan meant to bring generic drugs more quickly to market to compete with higher-priced brand-name equivalents.

Sen. Byron L. Dorgan (D-N.D.), chief sponsor of the importation amendment, said Friday: “Miracle drugs offer no miracles to those who cannot afford them. If we don’t do something to make drugs more affordable, seniors in the country lose, and others who need prescription drugs and can’t afford them lose.”

But Bush administration officials, like their predecessors in the Clinton administration, have been skeptical of large-scale drug importation. Regulators say they can’t ensure pharmaceuticals obtained in foreign countries meet U.S. safety standards.

Mark B. McClellan, commissioner of the federal Food and Drug Administration, cautioned lawmakers in a recent letter that the Dorgan amendment could create “a wide inlet for counterfeit drugs and other dangerous products that ... pose a threat to the security of our nation’s drug supply.”

The amendment would allow the Department of Health and Human Services to block the trial import program from taking effect. Key Republicans forced that escape valve onto the measure, which was opposed by major drug companies and some influential lawmakers.

“In this era of increased bioterrorist threats, we now more than ever should not be opening the door and passing a new drug importation legislation at all,” Senate Majority Leader Bill Frist (R-Tenn.) said.

A plaw enacted in 2000 would allow for importation of drugs from Canada and several other countries, but during the Clinton administration its implementation was thwarted by Health and Human Services Secretary Donna Shalala. Tommy G. Thompson, the current secretary, has followed suit. A similar import bill passed the Senate last year but died in the House.

In a bid to reduce the objections raised about the past importation plans, Dorgan limited his proposal to drugs obtained in Canada. In Friday’s debate, he contended Canadian drug regulations are comparable to those in the United States, which he said should answer safety worries.

But McClellan, in his letter, indicated that federal regulators remain skeptical.

He said the FDA is concerned about the accuracy of labeling information on drugs obtained from foreign countries and whether the medicine has been stored safely.

Also, Canadian health officials have said their government would accept no responsibility for the safety and quality of drugs exported to the United States.

In his Senate speech, Dorgan held up empty pill bottles as props to underscore the different prices for drugs made by a U.S. manufacturer on either side of the U.S.-Canadian border. A cholesterol-controlling drug cost $3.03 per tablet in the United States, $1.12 in Canada, he said.

“Why not let the market system resolve these issues?” he said.

The Pharmaceutical Research and Manufacturers of America, a trade group, condemned the Senate action. “We all should be concerned about the threat of substandard and counterfeit medicines,” said Jeff Trewhitt, the group’s spokesman.

He said Canadian drugs are cheaper than their U.S. counterparts because of government price controls in Canada that fail to account for the high costs of research and development.

Trewhitt said a better answer to the issue of high prescription drug prices -- which he called “a crisis” -- would be to enact a drug benefit under Medicare.

The Medicare bill Dorgan’s amendment was added to would provide such a benefit -- as well as expand the role of the private sector in the health-care program for seniors and the disabled.

Voting against Dorgan’s amendment were 25 Republicans and three Democrats. Supporting it were 40 Democrats, including Sens. Dianne Feinstein and Barbara Boxer of California and presidential candidates Bob Graham of Florida and Joe Lieberman of Connecticut. Also in favor were 21 Republicans -- many from states bordering Canada -- and independent James M. Jeffords of Vermont.

Ten senators missed the vote, including Democratic presidential candidates John F. Kerry of Massachusetts and John Edwards of North Carolina.