States Defy FDA on Drug Importation
By: Source: AARP Bulletin Today Date Posted: 2004-10-08 16:08:00-04:00
Weighing in where millions of ordinary Americans have already dared to tread, a growing number of states and cities are defying federal law and the power of the pharmaceutical industry to help people buy prescription drugs from abroad. In some cases they’re even filing lawsuits against those who try to stop them.
These smaller governments are in effect giving Washington an ultimatum: Allow Americans to buy lower-cost medications from Canada and other countries, or bring down drug prices at home. They’re also strongly challenging the position—long held by the White House, the Food and Drug Administration and the drug companies—that buying medications from licensed pharmacies abroad is not safe.
"This out-and-out state revolt against federal policy is a sea change in American health politics," says Jonathan Oberlander, a health care expert at the University of North Carolina in Chapel Hill. "States are very practical," he notes. "If they think they can save money by importing [drugs], they’re going to do it. So this is really a case of ideology at the federal level against pragmatism at the state level."
In an election year, the issue also resonates among older voters. Eight of 10 Medicare beneficiaries believe the law should be changed to allow Americans to import drugs from Canada, according to a recent survey by the Kaiser Family Foundation and the Harvard School of Public Health.
But it is the states that are forcing a showdown. None is yet directly importing drugs to reduce the costs of health programs, as several cities already do. But Illinois, Minnesota, New Hampshire, Wisconsin and the District of Columbia are pointing residents to websites of prescreened foreign pharmacies. Rhode Island has a law licensing Canadian pharmacies to trade in the state. The California legislature has passed a packet of importation bills. In all, 24 states have considered such measures.
The idea of saving millions of dollars by importing drugs is "catching fire" across the nation, Oberlander says, and in the process "makes it very hard for the Bush administration to hold onto this issue."
Even the bolder states at first moved cautiously, negotiating repeatedly with the FDA, the federal agency responsible for safeguarding the U.S. food and drug supply. But now some have run out of patience.
Illinois Gov. Rod Blagojevich, D, for example, said a year ago he would not proceed with importation without FDA approval. But last month he launched his state’s website despite the agency’s opposition.
"It’s been a frustrating experience working with the FDA," he says. "They’ve acted more like the guardian of the drug companies and their anti-free-market price structure instead of protecting the health and safety of American consumers."
Vermont took a different tack. In August, after the FDA rejected the state’s request to set up a pilot plan to demonstrate how importation from Canada could be done safely, Vermont filed a lawsuit against the agency, calling its decision "arbitrary and capricious and otherwise unreasonable." Vermont Gov. Jim Douglas, R, said he hopes the state’s action "will result in a legal precedent that benefits every Vermonter and every American."
Others are targeting drugmakers. The Minnesota Senior Federation, a grassroots group, has sued nine drug companies for alleged antitrust conspiracy in cutting off supplies to Canadian pharmacies that sell drugs to Americans. And 14 California pharmacies have sued 15 manufacturers, claiming they conspired to charge Americans "artificially higher prices" than those for the same drugs abroad.
All these actions—as well as opinion polls—are putting intense pressure on Congress to change the law. But the Senate is still waiting to vote on the bipartisan Dorgan-Snowe bill, introduced in April to allow safe importation from several Western countries and break the drug industry’s attempted blockade of Canada.
Feelings in the Senate are so strong that Finance Committee Chairman Chuck Grassley, R-Iowa, speaking to reporters at the Republican National Convention, said his own majority leader, Bill Frist, R-Tenn., was "doing everything he can to keep the bill from being up for a vote." He added: "If it was up, it would pass 75 to 25."
Frist didn’t schedule the bill for the Senate’s fall calendar, saying later that he still has safety concerns about importing drugs.
SAFETY—THE STICKING POINT
The Bush administration and the drug companies have long contended that legalizing importation would open American borders to a flood of counterfeit and unsafe medicines. In rejecting Blagojevich’s request to approve importation, Lester M. Crawford, acting head of the FDA, wrote that the agency must "ensure that any changes do not require American citizens to give up the ‘gold standard’ in drug safety that has become a hallmark in this country."
But Blagojevich no longer believes the United States holds the gold on this issue. Unlike the FDA, he has sent state officials to investigate drug safety procedures in Canada and six European nations. There, the officials reported, regulations and practices are sometimes more stringent than U.S. ones, and counterfeit medicines are rare. "Frankly," he says, "I don’t think our safeguards are as good as other countries."
Illinois is now setting up a clearinghouse that will provide "an additional layer of safeguards," Blagojevich says, by prescreening, approving and monitoring a network of licensed pharmacies and wholesalers in Canada, Great Britain and Ireland. Illinois residents will have access to them through a state website.
In arranging for imports from beyond Canada, Illinois has gone further than other states in defying the FDA. The agency has not yet prosecuted any state or city but doesn’t rule out action against Illinois. "It could come down to us taking this issue to court," says FDA associate commissioner William Hubbard. "We think this program is going to bring in illegal drugs that are potentially dangerous."
But by steering consumers away from dubious Internet sites (which are many) and toward approved foreign pharmacies that sell authentic medicines, Blagojevich says, Illinois is demonstrating what the FDA could, and should, do.
The Illinois fact-finding trip to Europe resulted in an 85-page report. It includes details of how prescription drugs are routinely sold across 18 national borders there, in a free market system known as parallel trade. Drug companies price drugs differently for richer or poorer nations, and wholesalers are permitted to export and import at the lowest cost.
Donald Macarthur, secretary-general of a London-based group representing parallel traders, says the system has worked well for 30 years and is tightly regulated. No case of harm to health has been reported. "And," he says, "there has never been a single confirmed case of a counterfeit medicine reaching a patient through parallel trade anywhere in Europe."
In contrast, counterfeiting within the United States is fairly common—prompting more than 20 FDA investigations a year—because high U.S. prices make it profitable and because any number of middlemen can repackage the drugs, making them harder to monitor. In Europe, patients receive drugs in containers sealed at the point of manufacture.
SEIZING INCOMING DRUGS
The FDA has taken no steps to investigate safety in other countries. "The law doesn’t provide for that," Hubbard says. But the agency periodically seizes incoming drugs, calling them "unapproved" even in cases of bona fide medicines that differ only in being labeled according to the laws of the exporting country. In July the FDA confiscated 350 packages ordered from Canada. The agency later informed the mystified intended recipients that, for example, their anti-cholesterol drug Lipitor (approved by the FDA in 1996) "appears to be a new drug without an approved new drug application."
Such legalistic niceties do not impress Thomas Motley Jr., of Cape Coral, Fla., a retired lawyer disabled from heart disease, whose drugs were seized in this raid. His shipments of Lipitor always arrive in the manufacturer’s sealed containers, he says, so "there can be no issue of the authenticity of my Canadian-sourced drugs."
Will importing from England and Ireland sidestep U.S. drug companies’ restrictions on drug supplies to Canada, as Illinois hopes? Not necessarily. Within a week of Illinois’ announcement, the giant drugmaker Pfizer imposed a quota system on British wholesalers, even though such restrictions are illegal in Europe.
To make importation work properly, U.S. law needs to "penalize manufacturers heavily for obstructing free trade," Macarthur says. "We know from bitter experience that even having the law on your side is not enough. Big Pharma will hassle and litigate on everything and allege dangers when there are none."
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