Canadian drug sales slow

Ann Griffith doesn't fit the stereotype of a criminal.

At 81, the Plymouth Meeting resident has been buying the thyroid medication Synthroid for three years from a Canadian Internet pharmacy. She shaved 40 percent off the U.S. price.

But from July to September, the Food and Drug Administration detained three of her packages at the Seattle-Tacoma airport. Agency letters stopped short of accusing her of breaking the law but required her to write or travel personally to Washington state to prove that the packages were legal.

"These laws are designed to protect you," one letter said.

Griffith, who said she never had any health problems with Canadian drugs, scoffed at the agency's actions. "The big drug companies don't want to lose anything," she said. "That's the whole thing."

Canadian drug sales to U.S. patients like Griffith were once a hot trend. But a variety of factors have stifled this continental trade, making it more like curling than hockey. Drug firms such as Pfizer Inc. and GlaxoSmithKline P.L.C. have threatened to cut off supplies to Canadian pharmacies catering to the U.S. market.

The Canadians have raised their drug prices, while the U.S. dollar has declined precipitously against the Canadian currency.

Most important, the U.S. government created a Medicare prescription-drug benefit, starting in January 2006, that made importing drugs less of a priority for vast numbers of seniors and the disabled.

Those developments have had a chilling effect on legal drugs flowing from north of the border. In 2006, sales by Canadian Internet pharmacies to the United States totaled $211 million Canadian ($225.6 million U.S.). That was nearly a 50 percent drop from $420 million Canadian in 2005, according to IMS Health Inc., a data firm in Plymouth Meeting.

But drug imports may not decline forever. Buying from other countries "is an idea whose time may come because the cost of drugs is so high," said Bill Trombetta, a pharmaceutical marketing professor at St. Joseph's University in Philadelphia.

Trombetta said savvy brokers in Europe already buy prescription drugs in cheaper countries, such as Spain and Italy, and resell them in more expensive ones, such as Germany and England.

A bill introduced this year by Sens. Olympia J. Snowe (R., Maine) and Byron L. Dorgan (D., N.D.) would ease restrictions on imports and improve safety by requiring registration of exporters and importers.

The Senate bill passed an early test by a healthy 63-28 margin. But it was shelved in May when Congress took up other drug-related measures.

The industry lobbying group, the Pharmaceutical Research and Manufacturers of America, has bitterly opposed imports, saying they could worsen counterfeiting and weaken the existing regulatory system.

The United States stands out among industrialized nations for allowing drugmakers to set prices with no government interference. That's a big reason why the U.S. market remains the most critical source of profits, which the industry says are essential to funding new drugs.

Since 1988, no one but a manufacturer or its licensee can legally import a drug into the United States. But the government has allowed individuals to carry back small amounts of prescription drugs for personal use.

The FDA has conducted periodic sweeps against drugs delivered through the mail. But its leaders admit they lack the staff to do a thorough job. Many observers say the agency has stopped short of criminalizing the process in part because it doesn't want to be prosecuting senior citizens or sick people.

FDA officials say they do not know for certain if Internet sales are increasing or decreasing. "We really don't have the resources to quantify the number of products coming in," said Ilisa Bernstein, the FDA's director of pharmacy affairs.

She said the agency uses a "risk-based approach," meaning that it tries to identify the riskiest drugs - those like Synthroid - that require close monitoring to be safe.

"What's scary is, a lot of these online sellers will sell you drugs without a prescription," Bernstein said.

Last week, the agency reported the results of its latest probe of Internet purchases. Of 2,069 drug packages examined, more than half - 53 percent - had FDA-approved generic versions. And nearly all of those could be bought at chain pharmacies for $4, or less than the shipping alone, the agency found.

"The data lead us to believe that many people are buying drugs online not to save money but to bypass the need for a prescription from their doctor, since these Web sites typically do not require the purchaser to have a prescription," Randall Lutter, the FDA's deputy commissioner for policy, said in a statement.

Many people have reasons to seek brand-name drugs outside the country. The number of uninsured Americans continues to rise, having hit 47 million in 2006, according to the U.S. Census Bureau.

Medicare recipients such as Griffith may buy outside the country because they chose cheaper Medicare plans without drug coverage.

Others on Medicare may spend their initial drug allotment and enter that dreaded coverage gap known as "the doughnut hole," where they must pay the full cost of brand-name drugs.

Plans typically cover the first $2,400 or so of a person's drug expenses and copays. But recipients then have no drug coverage until they incur an additional $3,850 in expenses.

"It's a huge deal," said Pedro Rodriguez, the former executive director of, and now a consultant for, the Action Alliance of Seniors Citizens of Greater Philadelphia.

His group regularly refers people to several sources, including the Minnesota Senior Federation, whose staff inspects Canadian pharmacies and makes it easy to order Canadian pills through its Web site: http://www.mnseniors. org/.

Isadore Kopstein, 85, of Northeast Philadelphia, spent seven months this year working out of the doughnut hole. The former owner of the Fran's Fashions retail chain takes eight medicines daily, most to treat heart disease and high blood pressure.

After exhausting his initial drug coverage, Kopstein had to pay $600 a month out-of-pocket for his medicines. He still had to keep paying monthly premiums for Medicare drug coverage.

Kopstein cites a litany of failings with the Medicare drug plan, which he considers captive to the insurance and pharmaceutical industries. But he supports the government on at least one issue: He won't buy drugs outside the country.

"I wouldn't feel safe, because in another country you don't know what control the government exercises over these things," he said.