SPRINGFIELD, Mass. - The nameplate on Mayor Mike Albano's sprawling mahogany desk in city hall reads, "The Buck Stops Here." It could just as well read, "The Revolution Starts Here."

A self-described "Kennedy Democrat" with his own private-label pasta sauce, Albano is the spearhead - and Springfield, Mass., is ground zero - for an outlaw movement against rising prescription drug prices that's quickly gaining credibility nationwide.

Mayor Mike Albano speaks to a group of senior citizens gathered at the Good Life Center (the local senior center) in Springfield, Massachusetts. (KRT Photo/Jonathan Olson)

Springfield is the first and only U.S. city to oppose the Food and Drug Administration by offering a drug coverage plan that lets city employees and retirees buy prescription drugs from Canada, where prices are 30 percent to 80 percent lower than those in the United States.

The plan has saved the city $600,000 since it began in July, and it could cut $4 million to $9 million from Springfield's annual $18 million drug bill. Springfield could use the money. It recently laid off 320 employees, including 76 police officers and 53 firefighters.

Cities and states facing similar budget cuts so far have shied away from so-called "re-importation" programs. The FDA says the programs are illegal and risky because foreign drugs might be unsafe, unapproved, counterfeit or stored, labeled and shipped improperly.

But emboldened by Springfield's success, more states and local governments are moving to create Canadian drug import plans. Congress is weighing the question as well. The flurry of activity crosses party lines and puts a number of governors and local bodies on a collision course with the FDA.

The agency is already trying to cut Springfield's Canadian drug-supply line by going after CanaRX Services Inc. of Windsor, Ontario. The company contracts with Canadian pharmacists to fill the Springfield's prescriptions. The FDA crackdown is meant to discourage other officials from planning similar programs.

"I would be very nervous if I were a public official who sent my employees or citizens to a foreign country to buy illegal drugs that could harm them," said William Hubbard, an FDA senior associate commissioner. "I would certainly have trouble sleeping knowing that someone could die taking one of those drugs and I could be held responsible."

Also See: Springfield Mayor Urges Fiscal Strike at Drug Companies Boston Globe 9/29/2003

Such concerns haven't stopped Albano. He said the U.S. government faces similar liability questions by ignoring federal law and allowing consumers to bring prescription drugs back from Canada.

"Does that put the U.S. Customs Service, the Justice Department and the FDA in a position of liability if they come back with a counterfeit medication? I have to figure we're in the same position they are," Albano said. "I can't develop public policy based on liability."

Others agree.

- Massachusetts union leaders representing more than 30,000 state employees have asked a state panel to consider importing drugs from Canada.

- Minnesota Gov. Tim Pawlenty is planning a Web site where state residents can purchase Canadian drugs. He's also offering incentives to state employees that buy through the service.

- Illinois Gov. Rod Blagojevich has directed state officials to study the costs and benefits of a Canadian drug plan. A feasibility report is expected next week. The governor also created a national on-line petition (http://www.affordabledrugs.il.gov) that urges Congress and the FDA to legalize all drug purchases from Canada.

- West Virginia Gov. Bob Wise is looking at ways to cover Canadian drug purchases with state insurance. Iowa Gov. Tom Vilsack is doing the same, as are state officials in Wisconsin, Michigan and Ohio.

On the local level, the Burlington, Vt., city council gave the mayor until December to develop recommendations for a plan for city employees. The Cambridge, Mass., city council on Monday called for the city manager to do the same.

And in Washington, bipartisan majorities in the House of Representatives and the Senate voted last summer to allow American consumers the right to purchase prescription drugs from Canada. House and Senate negotiators are weighing whether to add such terms to pending Medicare-overhaul legislation.

Albano said the rush of activity - particularly by the governors - was heartening.

"I was waiting for a state to move forward on this issue," he said. "Obviously it adds a lot of credibility to our position."

Re-importing drugs from foreign countries such as Canada is a multimillion-dollar industry because of lax FDA enforcement and consumer frustration with spiraling U.S. drug prices. Canada's Internet drug sales are projected to double this year to $1.4 billion, according to Jupiter Research, a research firm in Darien, Conn.

Springfield's re-importation program is voluntary for employees, retirees and their dependents. The plan pays a patient's entire cost for the purchase of some 200 "maintenance medications" used to treat such chronic conditions as arthritis, high blood pressure and diabetes. The drugs must be purchased in three-month supplies. So far, 1,600 people have enrolled.

Albano, who buys insulin through the plan for his diabetic 13-year-old son, said he didn't intend to be a rebel. It was all about saving the city money.

"We had a choice. We could continue to reduce services to pay for rising health care costs or do something to reduce costs. We chose to reduce costs," Albano said.

So far, the FDA has taken no action against Springfield or Albano.

"We have not contemplated any enforcement action," against any local or state government, said William Hubbard, an FDA senior associate commissioner. "That's not even something we've, frankly, even discussed."

Instead, the FDA has gone after the plan's drug supply line through CanaRX. The company's doctors review prescriptions for Springfield patients that are written by their U.S. doctors. The prescriptions are then forwarded to Canadian pharmacies that fill the orders and ship the drugs by mail. CanaRX is responsible for making sure the products are packaged and shipped properly.

Because the FDA has no regulatory authority over a foreign-based company, it has asked the Canadian government to assist with its enforcement efforts against CanaRX. Hubbard said the FDA is awaiting a response.

An FDA warning letter to CanaRX President G. Anthony Howard claims the company's actions violate federal law and jeopardize public health. Howard, who couldn't be reached for comment, denied the allegations in an Oct. 21 letter to the FDA, which is posted on the company's Web site, www.CanaRX.com.

"Contrary to the agency's assumptions and assertions, we take numerous steps to safeguard our customers' health and safety, and what we do creates no risk beyond that faced by U.S. consumers conducting similar transactions domestically," the letter states.

Howard also challenges the FDA's claim that the company was responsible for an unrefrigerated dose of insulin, which was subsequently inspected and pulled by the FDA during a recent sting operation conducted at postal facilities around the country.

Howard claims it's "inaccurate and unfair to make a blanket assertion as to the inadequacy of CanaRX's shipping practices on the basis of a single episode, particularly one that is contrary to our policies and that we cannot corroborate," the letter reads. Even if the event did occur, "this rare occasion does not create a risk any greater than that posed by everyday domestic U.S. shipments of mail- or Internet-ordered insulin," Howard added.

Copyright © 2003 Knight-Ridder

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