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Illinois Governor Launching Program to Reimport Drugs

Move May Force FDA's Hand

By Marc Kaufman
Washington Post Staff Writer
Tuesday, August 17, 2004; Page A13

Despite opposition from a federal agency, Illinois will soon become the nation's first government to help residents buy cheaper drugs not only from Canada but from the United Kingdom and Ireland as well.

In an announcement later today, Gov. Rod Blagojevich (D) is scheduled to unveil the program, which will be coordinated and managed for the state by a Canadian pharmacy benefits company .

"People across Illinois, and across our country, deserve access to safe and lower cost prescription drugs," Illinois Gov. Rod Blagojevich (D) said in a statement. (Charles Bennett -- AP)

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The move by Blagojevich, who for months has unsuccessfully pressed the federal government for approval to run a pilot drug-reimportation program, significantly escalates the national dispute over the safety and wisdom of buying cheaper prescription drugs from abroad.

The U.S. Food and Drug Administration has forcefully objected to efforts to formalize drug purchases from Canada and elsewhere, saying it cannot vouch for the safety of drugs imported outside the federal regulatory system. But states, counties and municipalities have increasingly ignored the warnings and sought ways to help their residents purchase the cheaper drugs.

"We have taken every possible step we could think of to convince the FDA, the Congress, and anyone and everyone who will listen, that people across Illinois, and across our country, deserve access to safe and lower cost prescription drugs," Blagojevich said in a statement. "The federal government has failed to act. So it's time that we do."

States such as Minnesota, Wisconsin and New Hampshire have created officially sponsored Web sites listing Canadian pharmacies they have inspected and found to be safe and less expensive than American pharmacies. But the Illinois plan is significantly expanded, in that it will allow purchases from Europe and will hire the pharmacy manager to act as a clearinghouse and gatekeeper for residents who want to buy prescription drugs.

Blagojevich sent a team to Europe in May to assess pharmacy and manufacturing practices, as well as warehousing and storage, and identified those pharmacies and distributors that had standards comparable to those in Illinois. In all, about 50 pharmacies in Canada and Europe will be included in the network that will be run by the yet-to-be-named pharmacy benefits manager.

Officials said the plan -- which will make available about 100 common, name-brand medications -- will use pharmacies only in Canada, Ireland and the United Kingdom, to avoid any language problems. But because of the European Union's free-trade policies, drugs purchased in Ireland and the United Kingdom are often manufactured and packaged in other European nations. Some also have been shipped from England or Ireland to other EU members and then reimported -- a process, similar to what happens with the United States and Canada, that takes advantage of price differentials between more- and less-developed European nations.

Under federal law, it is illegal to import prescription drugs. Starting in the 1990s, however, elderly Americans began traveling to Canada for cheaper drugs and the FDA did not interfere. While the agency has strongly criticized states with Web sites linked to Canadian pharmacies, it so far has not done anything to close them down.

William Hubbard, the FDA's associate commissioner for policy and planning, said the Illinois plan might force the agency's hand.

"It may come down to us going to a federal judge for a ruling on this, to make clear that the law means what it says," Hubbard said. "We have here a state taking the further step to induce people to buy drugs from Canada and the United Kingdom, something we consider to be both illegal and unsafe."

Rep. Rahm Emanuel (D-Ill.) has co-sponsored legislation, which has passed the House but not yet the Senate, that would legalize drug importing from Canada and 25 other nations. He said this past weekend that American consumers need access to European markets because some large drug companies have begun to limit supplies of their medications to Canada.

"This is all about the fact that American consumers pay the highest prices in the world for prescription drugs because there's no free market here," he said. "The drug companies want to limit supply, and we want to increase it."

In recent weeks, the issue has become part of the presidential campaign, with the Democratic nominee, Sen. John F. Kerry (D-Mass.), voicing support for allowing imports from Canada and elsewhere.

Prescription drug prices are controlled by government in Canada and Europe, and so are significantly lower than in the United States. Drug companies in the United States say they need the higher prices to pay for the hundreds of millions of dollars in research and development needed to come up with a new medication.

Illinois officials said the new program will be limited to drugs used to treat chronic illnesses, but will not include pain medications or drugs such as insulin that can spoil during shipment. To enroll in the program and receive drugs, a patient will need an original doctor's prescription to be mailed or faxed to the clearinghouse for review.

© 2004 The Washington Post Company