22 May 2004

Potomac Watch: Debate on prescription drug imports

WASHINGTON -- The debate over importation of cheap prescription drugs from other countries has shifted here from arguments about whether the practice should be done to how it should be done.

The House already has passed a bill to further legalize and regulate importation and several bills are working through the Senate. Majority Leader Bill Frist, R-Tenn., has promised a floor vote on the issue this year. Health and Human Services Secretary Tommy Thompson has said government approval of importation is "inevitable" and even industry opponents concede defeat.

"We started sensing (a shift) beginning early this year," said Robert Falb, congressional affairs director for the Healthcare Distribution Management Association, the industry group for wholesale distributors of prescription drugs.

The first crack in the wall stopping imports was the switch in positions of Sen. Ted Kennedy, D-Mass. The crack widened when Mississippi Sen. Trent Lott announced his support, Falb said.

"I can no longer explain to my 90-year-old mother why her medications cost more than the same drugs from other countries," Lott, a Republican, wrote in an explanation of his position switch in late March. "I'm telling pharmaceutical companies to address the overall rising cost of their products or the federal government will, and it won't be pretty," he added.

Name-brand drugs sold in Canada and the European Union typically cost 40 percent to 60 percent less than in the United States, and the savings are drawing an increasing number of individuals, as well as health plans run by local and state governments, to rely on imports.

Currently under federal law, only drug companies can legally import drugs. But several million Americans, most of them seniors, are thought to be buying their medicines outside the country, either in person, through the mail or on the Internet.

Officials estimate that some 20 million packages containing prescription drugs are shipped into the country each year, a trade worth more than $3 billion and growing, but still just a fraction of the $184 billion medicine market in the United States last year.

Congressional experts calculate that 10 percent to 15 percent of the drugs sold in the country might come from imports if the trade were made legal.

The major issue now is safety, as drugs coming in to the United States from other countries open the Food and Drug Administration's closed regulatory system.

"Consumers are exposed to a number of potential risks when they purchase drugs from foreign sources or from sources that are not operated by pharmacies properly licensed under state pharmacy laws," said John Taylor, associate commissioner for regulatory affairs at the FDA, at a Senate committee hearing on the issue on Thursday.

These risks include buying expired, contaminated and counterfeit drugs, as well as being exposed to pills that are the incorrect dosage and packaged with instructions in foreign languages, he said.

Investigations into counterfeit drugs, once rare, have increased fourfold since the late 1990s and the FDA has limited ability to stop activities occurring outside the country, Taylor said.

But counterfeit drugs also enter the system internally and no one has reported being harmed by drugs received from Canada.

"Even though a patient might never be harmed, they might not be getting the full therapeutic benefit," Taylor said in response to questions from Sen. Patty Murray, D-Wash., on that issue.

FDA officials at the hearing conceded that an importation system from Canada that allowed only drugs manufactured in the United States and Canada would alleviate safety concerns.

Those officials also want an electronic tracking program for drugs and senators at the hearing agreed that the FDA would need more money for these new programs.

One of the popular Senate bills is a bipartisan measure authored by Sen. Byron Dorgan, D-N.D., that would allow importation of drugs if the FDA had approved those medicines -- except for controlled substances and a few other exceptions -- and if the drugs were manufactured in an FDA-inspected plant.

Individuals could import a 90-day supply of medicine from Canada and could bring back that same amount if they traveled abroad to the European Union, Japan, Switzerland or New Zealand and bought drugs there.

Wholesalers and pharmacies could import drugs from all those sources.

Despite this push in Congress, some drug companies are still resisting the importation efforts. And some Canadian doctors have stopped writing prescriptions to Americans for fear of lawsuits.

A Minnesota seniors group this week filed a lawsuit against nine major drug companies, alleging the companies are conspiring to keep drug prices high by limiting supplies to Canada.

Dorgan's bill would prohibit drug companies from taking action to stop drug importation.

In Washington state, senior groups welcomed Congress' actions, but said more is needed.

"This isn't the answer, really, it's only a stop-gap measure," said Jason Erksine, spokesman for AARP of Washington state. "We have to ultimately do something about the high cost of drugs; that's the root of the issue."

Irene Hull, a 90-year-old Seattle resident, agrees. She doesn't take pain medication for a slipped disc in her back because the pills are too expensive. If any groups plan a bus trip to Canada to buy medicine -- a practice that has waned since the rise of sales on the Internet -- she said she will go.

But until then, "I just have to live with pain that is at times excruciating and that's the way it is," Hull said.

Potomac Watch is a weekly look at issues and personalities in Washington, D.C. P-I reporter Wyatt Buchanan can be reached at 202-263-6433 or [email protected] This report includes Information from Scripps Howard News Service.

© 1998-2004 Seattle Post-Intelligencer
By WYATT BUCHANAN SEATTLE POST
INTELLIGENCER WASHINGTON BUREAU
Saturday, May 22, 2004

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