Drug reimportation booms as U.S. safety task force is named

Washington -- The reimportation of U.S.-made prescription drugs continues to snowball, even though it remains illegal and the federal government is only now beginning to study whether it can be done safely.

Indicative of growing support in Congress, a reimportation provision in the recent Medicare reform package mandates that the Dept. of Health and Human Services deliver an official report on reimportation to Congress by Dec. 1. HHS Secretary Tommy Thompson recently announced the formation of a task force to produce the report.

"This task force will study what it would take in terms of oversight and resources to safely import drugs," he said. "It will hear from all sides of the issue in a public, transparent manner. I'm confident that it will produce a balanced picture of the costs and benefits of drug importation."

The task force needs to take a long, hard look at whether reimportation places Americans in potential jeopardy, said AMA Trustee Edward L. Langston, MD.

"We understand that seniors have financial issues," he said. "But we want to make sure they have a safe venue."

Some reimportation proponents question how balanced the report will be, considering that the panel is to be chaired by Mark McClellan, MD, PhD, an outspoken opponent of drug reimportation, who at press time, was FDA commissioner.

"To date, the Bush administration has kowtowed to the pharmaceutical industry all down the line, including on this issue," said Ron Pollack, executive director of the consumer group Families USA.

Under Dr. McClellan, the FDA has conducted inspections that have uncovered questionable prescription drugs being imported into the country.

"This is nothing more than a campaign of distraction," said Rep. Gil Gutknecht (R, Minn.), one of the leading reimportation proponents. "The bottom line is that millions of Americans will continue to seek more affordable markets abroad. The question is what are we going to do to make it as safe as possible?"

Even those generally opposed to reimportation say it is not impossible to do it safely. But they warn that the resources needed to ensure the safe reimportation of prescription drugs might make them no less expensive than drugs already available on the U.S. market.

Not the best solution

Whether supporting or opposing drug reimportation, experts agree that the underlying problem is the high cost of prescription drugs.

Reimportation "isn't a good policy solution to the problem, but it points out what the real issue is here, which is that our government is letting down its citizens by not negotiating for better prices," said Chellie Pingree, president of Common Cause, a Washington, D.C.-based public lobbying group that tracks the influence of other lobbying groups on government.

A lack of drug price controls, such as those imposed by almost every other developed country, has allowed pharmaceutical companies to continue reaping record profits even during a recession, experts said.

This has led to a substantial inequity for Americans, who are not only bearing the lion's share of the cost of drug research and development but also being hit with growing cost-sharing from insurers. Americans, especially seniors, are having sticker shock from the amount they personally spend on drugs.

"You have a generation of people becoming Medicare age who aren't used to paying for anything," said Larry Kocot, senior vice president of policy and regulatory affairs for the National Assn. of Chain Drug Stores, in Alexandria, Va.

These factors have driven a dramatic rise in the number of prescriptions purchased from Canada.

Seniors in northern states are making regular bus trips to pharmacies across the border. And consumers are buying more drugs from online pharmacies that import from Canada or at least purport to get their drugs from there.

"From what we hear, the Canadian system is already being overwhelmed by American citizens who go up there to get their prescription drugs," said Tom Engels, spokesman for the Pharmacy Society of Wisconsin. "Canadians are now starting to say: 'Take care of us first and then take care of the Americans.' "

Pushing the envelope in Canada

While it may be one thing to walk into a Canadian drug store to fill a prescription, it's another to get a mail order from a Canadian pharmacy, Kocot said. Canada is seeing a burgeoning gray market in pharmaceuticals, due to increased pressure on the system from the U.S. market.

Now that U.S. pharmaceutical companies are cracking down on Canadian pharmacies that send drugs across the border, many of those pharmacies are looking to alternative sources to fill their growing demand from American patients. This places U.S. patients completely outside the systems that are regulated by the FDA or by HealthCanada.

"A drug that has not been certified by HealthCanada cannot be dispensed to a Canadian citizen, but it can be exported to the United States and be given to an unsuspecting American citizen," Engels said.

He also noted that getting drugs from Canada through the mail introduces a much greater likelihood of prescription errors. While Wisconsin's pharmacists see patients in person and can call physicians to confirm prescriptions, no such checks and balances exist for drugs shipped from Canadian pharmacies.

But with little actual data showing patient harm, these safety concerns have failed to stem the tide, as state and local officials from both parties continue to encourage the trend.

Local governments weigh in

Several city and state governments already have set up online and phone-based systems to help residents order drugs from Canada. A group of governors has requested permission from the federal government to start importing and warehousing prescription drugs from Canada.

Illinois Gov. Rod Blagojevich recently joined a class-action lawsuit filed by Illinois couple Ray and Gaylee Andrews seeking to force the federal government to publish rules allowing states and individuals to import drugs from Canada.

"The primary job of government is to protect the health and safety of the people," Blagojevich said. "We are not here to protect the financial interests of the pharmaceutical industry."

But the state's efforts have local physicians worried.

"The governor has certainly taken this and run with it," said William Kobler, MD, president of the Illinois State Medical Society. "The safety concern is a very real one, even though the people who are for reimportation just kind of pooh-pooh that."