Still no deal on Irish drubs (Chicago Tribune) -- Irish Media Watch Message Board

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Date Posted: 13:01:59 08/28/04 Sat GMT
Author: Lynn
Subject: Still no deal on Irish drubs (Chicago Tribune)

Still no deal on Irish drugs

No state contact with wholesalers
By Courtney Flynn and John Chase
Tribune staff reporters

August 27, 2004

Though wholesale drug purchases from Ireland are a component of Gov. Rod Blagojevich's ambitious prescription drug importation plan, that country's major wholesalers all say they have not been contacted by the governor's office.
What's more, at least two of the three main firms that distribute drugs in Ireland say they would refuse to participate in Blagojevich's plan if asked.
"There would be too many issues concerning labeling and approval that would create difficulties in trying to have drugs licensed and sold in Ireland for sale in the United States," said Pauline McAlester, a spokeswoman for United Drug, one of Ireland's major wholesalers.
A spokesman for another large wholesaler, UniPhar, said he was unaware of any contact with the governor's office about the plan.
Officials with a third wholesaler, Cahill May Roberts, could not be reached for comment Thursday. But Patrick Tracey, the company's managing director, told Dublin's Sunday Tribune that his firm had not been approached about the plan and would not provide drugs anyway because of concerns about labeling and approvals. In addition, Illinois' plan could create prescription drug shortages in Ireland, Tracey told the newspaper.
Last week, Blagojevich teamed with Rep. Rahm Emanuel (D-Ill.) to announce the creation of a network of pharmacies and wholesalers in Canada, the United Kingdom and Ireland from which they said Illinois residents could next month begin safely buying prescription drugs for up to 50 percent less than in the U.S.
The governor did not lay out exactly how consumers could access the prescription drugs from Europe, promising details would come when the program ramped up in September.
The federal Food and Drug Administration has opposed drug imports, citing safety concerns, and the Bush administration has resisted efforts to overrule that position. However, with the high drug costs threatening to hand Democrats a potent issue as he faces re-election, President Bush last week said he had ordered a study to examine whether cheaper drugs could be imported without compromising safety.
Despite the reticence of the Irish wholesalers, Abby Ottenhoff, a spokeswoman for Blagojevich, said 35 wholesalers and pharmacies in Canada, the United Kingdom and Ireland have already signed letters of intent to participate in the state program. But Ottenhoff declined to name them, adding that their identities would never be revealed because drugmakers who oppose Blagojevich's importation plan could retaliate by cutting supplies to them.
Following inquiries by the Tribune about the Irish wholesalers, Blagojevich's office issued a statement Thursday attacking Pfizer, the giant New York-based drugmaker, for threatening to stop supplying any UK wholesalers that participate in the program.
"Pfizer's action shows an utter disregard for the health of our citizens and highlights the real motivation behind their opposition to prescription drug importation: enormous profits," Blagojevich said in the statement.
Pfizer officials could not be reached for comment.
Scott McKibbin, one of the architects of the governor's drug plan, dismissed Tracey's fear that the plan would create drug shortages in Ireland. As a member of the European Union, Irish wholesalers can easily replenish their drug supplies from other members of the trade group under existing rules that allow for free movement of goods between the countries.
Illinois, he said, would simply be tapping into that system.
However, a recent report on the drug program commissioned by Blagojevich and co-authored by McKibbin warned that European drug shortages were possible if Illinois' program went forward. Noting that drugmakers had restricted supply to Canadian Internet pharmacies as punishment for selling to U.S. consumers, McKibbin said European nations "might expect a similar response."
The Blagojevich import plan could be rendered "impractical" if Europeans don't help out by imposing sanctions against drugmakers that attempt to cut off supply, McKibbin warned.
After Blagojevich announced his importation initiative last week, government and pharmacy industry officials in Ireland told the Tribune they were surprised by the plan and stressed that Irish law banned mail order prescriptions in that country.
Blagojevich aides said they were aware of the Irish prohibitions and had devised a workaround. Instead of buying direct from Irish retailers, they would work with Irish wholesalers who would ship prescription drugs to the United Kingdom, where sales through the mail are legal.
Blagojevich earlier this year dispatched McKibbin and others to Europe to study the feasibility of a drug importation plan. The delegation said it met with officials of the European Medicines Agency, the EU's equivalent to the FDA.
A spokesman for the Medicines Agency acknowledged Thursday that such talks took place but stressed that they were confined to discussions of how drugs are distributed with the EU. The agency is not empowered to regulate imports and exports of drugs, and it did not sign off on the Blagojevich proposal, the spokesman said.
McKibbin said the authority and approval for the plan stems from the Treaty of Rome, which formed the EU and provides for free trade.
"We talked to them about what we were doing and what was legal under the EU system and regulations, and that's how we came up with the plan we came up with," McKibbin said.
Blagojevich said at a meeting with the Tribune's editorial board on Thursday that his plan is part of a larger objective to pressure the Bush administration to break down barriers to the importation of cheaper drugs, which the FDA maintains could pose safety risks.
William Hubbard, an associate commissioner for policy and planning with the FDA, has said that federal law prohibits importation, but whether the state, acting in the capacity as an intermediary and not as the direct marketer in its plan, would be acting illegally is less clear.
"There's a Berlin Wall right now that the big drug companies have been able to erect that stands in the way of freedom, OK?" Blagojevich said. " ... Mr. Hubbard, tear down that wall."

Copyright © 2004, Chicago Tribune

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