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FDA calls Springfield drug plan illegal, but stops short of action

Food and Drug Administration commissioner Mark McClellan warned yesterday that the City of Springfield's program to purchase low-cost drugs from Canada for its employees and retirees is illegal and could compromise patient safety, but he stopped short of saying the FDA will take any enforcement action.

McClellan said the FDA would welcome discussions with Springfield Mayor Michael Albano over the city's program. While not ruling out future legal action, he said the agency would simply urge Albano to take a path other than one that leads across international borders.

"We should not be sacrificing safety or quality for the sake of saving the government a few bucks," McClellan said in an interview when asked about the FDA's response to Albano's initiative for as many as 20,000 city employees, retirees, and family members. "I don't agree that people should have to trade off safety with price in order for a local government to save some money."

Because of Canada's strict price controls on prescription drugs, which provide discounts of up to 80 percent over US prices, elderly Americans and Internet shoppers have turned to Canadian pharmacies in droves to buy brand-name pharmaceuticals.

The practice is illegal, but the FDA has declined to enforce the imports for individual purchases. It has issued warning letters and sought to shut down US "store fronts" that specialize in securing Canadian drugs for Americans, but Springfield's move apparently represents the first time the agency has been confronted with the prospect of a municipal government violating federal law.

Questioned yesterday after he spoke before a convention of drug industry and biotech executives in Boston, McClellan struck a conciliatory tone toward Springfield and stuck to generalities, even as he warned of potential dangers in the city's program. He said illegal foreign imports could expose citizens to medicine that has been counterfeited, stored improperly, or marketed beyond its expiration date.

If the FDA does decide to intervene, it would be in the context of a "strong caution" it issued in an advisory letter in February, McClellan said. In that letter, the FDA warned that people who operate programs aimed at skirting US prohibitions on drug reimportation face potential criminal and civil sanctions.

"I think people are angry about the price differences between Canada and other countries and the United States," McClellan said. But, he said, "when people buy outside our system for regulation and our system for ensuring drug safety, they do take chances."

Albano said yesterday the city has not received any warnings or questions from the FDA about its purchasing plan, which he estimated will save Springfield $4 million to $9 million annually. The city attempted to craft its program within the federal government's guidelines for individual purchases, with voluntary participation by employees and mailings directly to patients. The only FDA reaction he has seen, he said, is from press accounts.

Springfield's initiative is being watched by city officials in Worcester, Lowell, Revere, and Pittsfield, and has the potential to spread to other places if it is successful, Albano said. The mayor gave his own perspective on the program in an op-ed piece in Sunday's Washington Post. The mayor said he has been buying insulin for his son, a diabetic, from Canada since March and has no evidence that any drugs from Canada have been tampered with.

"If there's something wrong with this picture, demonstrate it to me," Albano told the Globe yesterday. "No one has been able to do it other than these vague scare tactics that I don't think anyone is buying."

In addition to raising safety concerns, the drug makers' lobbying arm, the Pharmaceutical Research and Manufacturers of America, has argued before Congress that it needs to keep low-cost drugs out and protect its higher US prices to ensure a steady stream of money for drug discovery. The industry says it spent $32 billion on research and development in 2002.

The lobbying efforts on all sides have heated up this summer. On a bipartisan vote, the House passed a Canadian drug reimportation bill that would make it legal for Americans to buy drugs from other countries. The measure, which is tied up in debate over a Medicare prescription drug benefit, faces opposition in the Senate, including from Senator Edward M. Kennedy, Democrat of Massachusetts, who says the legislation would allow importation from too many countries to ensure safety.

Several drug companies including GlaxoSmithKline PLC and AstraZeneca PLC have clamped down on the supply to Canada to slow the flow of cheaper drugs back into the United States. The most recent was Pfizer Inc., which said last week that it was requiring 46 pharmacies it believes are engaged in the reimportation trade to order drugs directly from the manufacturer instead of from wholesalers.

Prescription drug prices were a major theme at the podium as the Drug Discovery Technology World Congress entered its second day yesterday at the Hynes Veterans Memorial Convention Center in Boston. McClellan said speedier, more predictable reviews and better applications from the industry would help reduce costs. Republican Governor Mitt Romney gave the assembled scientists and drug industry executives a blunt message: The industry is suffering from a public-relations problem, largely because of its drug prices.

"An important part of drug pricing has to be the implications of drug pricing on public opinion, on political opinion, on the way our entire governmental system approaches the industry," Romney said. "Industry as a whole needs to do better communicating to the public."

A major flash point in Massachusetts State House debate this year was over a plan to allow Massachusetts state government to engage in "bulk purchasing" as a way to leverage lower prices from drug companies. Democrats have complained that Romney sent back a watered-down proposal this summer after the purchasing plan passed both the House and Senate, in effect killing the measure for the year.

Democratic Senator Mark C. Montigny of New Bedford, a champion of drug reimportation, took a shot at Romney yesterday, calling his comments before the conventioneers "wind-bagging."

"Talking tough to this industry is irrelevant," Montigny said.

Christopher Rowland can be reached at crowland@globe.com.

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