Drug import crackdown shows hazards

Washington -- The federal government's aggressive targeting of drug shipments from outside the country has turned up what could be a dangerous emerging trend: reimportation from "mystery" countries.

For example, officials recently confiscated a shipment of more than 400 prescriptions bought from a Canadian mail-order pharmacy. The drugs were actually shipped from the Bahamas, and came from places such as Singapore and Pakistan, said Tom McGinnis, the Food and Drug Administration's director of pharmacy affairs.

When contacted by the FDA, the people who purchased the drugs couldn't believe the medications were coming from the Bahamas, he said.

The FDA hadn't tested the content of the drugs, but "I wouldn't take some of these," McGinnis said. As the practice of reimportation grows, so will the number of drugs coming from mystery countries -- nations other than the one the consumer ordered from, he predicted.

As part of an information campaign to discourage reimportation, the FDA released a price comparison chart showing that generic versions of many of the drugs purchased in that shipment were actually available at lower prices from U.S. pharmacies.

Although still illegal, reimportation is becoming a boom industry as more and more seniors take advantage of the promise of bargain medications available from Canada, Mexico and beyond. Warnings from drug companies, doctor groups and federal regulators over safety concerns have so far largely fallen on deaf ears.

The recent example is not the first time the FDA has raised the red flag after stopping suspicious shipments of drugs coming across the border. Shipments from Canada and Mexico have contained impure and poor-quality versions of FDA-approved medications.

But data on the quantity and quality of drugs coming from Canada that are actually from elsewhere are hard to find.

"There have been reports of that, but that doesn't mean that they are adulterated drugs on the one hand. On the other, what you have seen is a paucity of reports on people actually suffering from adulterated drugs," said Roger Pilon, PhD, vice president for legal affairs at the Cato Institute, a libertarian think tank in Washington, D.C. "There is a difference between the two that needs to be taken into account."

U.S. drugmakers might have an indirect hand in the spread of drug reimportation from other countries, he said.

Until recently, it has been relatively safe to order drugs from Canada, but pharmaceutical companies' attempts to discourage the practice may impact that, Dr. Pilon said.

"When drug companies start to limit supplies to Canadian wholesalers, those Canadian wholesalers have an incentive to get their drugs elsewhere to supply the American market," he explained.

Pfizer Pharmaceuticals, one of the companies criticized for this practice, is enforcing a stipulation of its contract with Canadian wholesalers, which, in compliance with U.S. laws, prohibits the export of medications to the United States, said spokesman Jack Cox.

Reimportation legislation that has been introduced in the Senate would bar firms from strategically limiting supplies to Canadian distributors.

What price to pay?

Even as the companies attempt to block reimportation efforts, they recognize that the current system, in which American consumers foot the bill for the bulk of the world's innovative drug products, is a problem, said Jeff Trewhitt, a spokesman for Pharmaceutical Research and Manufacturers of America.

"The fact of the matter is that the price controls in these other countries, like France and Canada, have hurt the ability of companies there to create new medicines. But they've got the American companies to rely on, and they're benefiting inappropriately from the artificially low prices," he said.

Reimportation would hurt drug companies' profits and reduce investment in research, he added.

"We have a whole series of policies in this country -- investment tax credits, patent laws, etc. -- which are designed to make the pharmaceutical industry one that is attractive to investing," said Dean Smith, PhD, professor of health management and policy at the University of Michigan in Ann Arbor.

American consumers might be willing to gamble the future of innovation for lower-priced drugs now, but it would be hard to predict exactly what the public would be giving up, he said.

"You can see why there would be a lot of political support for this kind of legislation because you get the benefits of lower prices for people without insurance right now," Dr. Smith said.

The cost that people pay is seen in "drugs that don't get developed. Since you don't know right now what those drugs are, you don't really know the cost," he added.

In Congress, the drumbeat for legalization of reimportation has steadily grown. Several bills have been introduced, including legislation that would circumvent a stipulation in current law that the Dept. of Health and Human Services certify that the practice is safe.

The American Medical Association has opposed reimportation unless HHS could show it was safe, but officials from both the Bush and Clinton administrations have said they cannot offer such assurances.

In a recent policy analysis, Dr. Pilon argues that lifting the ban on reimportation would most likely force drug companies to lower the price of drugs sold here while raising the price in other countries, making reimportation a moot issue.

Others, including many lawmakers, argue that reimportation would be safer if the FDA dropped its objections and started regulating it.

The FDA already successfully oversees the legal reimportation conducted by the pharmaceutical companies themselves, the National Breast Cancer Coalition said in a statement.

"While the broader issue that must be addressed is the high cost of drugs, we support importation programs that are adequately regulated and can provide immediate cost savings for consumers," NBCC President Fran Visco said at a recent news conference urging Congress to pass reimportation legislation.

But approval is unlikely this year. Senate leadership has blocked any official debate or vote on reimportation measures.

Without a new law, the FDA remains bound by its interpretation of the current laws. In the meantime, concerns about the strength, purity and quality of those drugs remain, McGinnis said.