The Montgomery County Council voted yesterday to begin buying medications in Canada, joining a handful of local governments and nearly 2 million U.S. consumers in defying federal law.
The council's decision will give as many as 85,000 county employees, retirees and their dependents the option of obtaining lower-cost "maintenance" medications from a Canadian vendor as soon as February. Proponents say the county could save as much as $20 million a year if members of its health plans fully embrace the initiative.
Montgomery's action reflects rising frustration with the federal government, which declines to approve Canadian imports but does not bar individuals from ordering or bringing in such drugs or stop local governments from facilitating their efforts.
"What we are seeing all across the country is that the credibility of the Food and Drug Administration is being questioned," said Council President Steven A. Silverman (D-At Large).
In many cases, drugs sold in Canada are produced in the United States under the supervision of the FDA and sold at lower prices in Canada as a result of government regulation. But FDA officials say they cannot guarantee the safety of substances that have left the tightly regulated U.S. pharmaceutical industry. Even reimported drugs, in the FDA's eyes, are illegal.
Because the FDA is based in Rockville, the council's action may resonate more loudly than similar steps taken by other communities. "Clearly the fact that the county in which the majority of FDA employees live and work would ignore the FDA's fundamental statutes is an example of the level of concern about the high cost of drugs," said William K. Hubbard, associate FDA commissioner.
He reiterated warnings that the federal government might go to court to block the program but acknowledged that it has refrained so far from using legal action to challenge local governments that have drug importation options for their health plan members.
Council member Tom Perez (D-Silver Spring), the main sponsor of Montgomery's initiative, acknowledged that the council risks court action. "Are we pushing the envelope? You bet," he said. "But there is a significant basis for pushing the envelope."
That basis includes a track record of satisfaction among other local governments that have turned to Canadian pharmacies to reduce health care costs.
Montgomery, Ala., has been offering employees, retirees and dependents the opportunity to buy drugs from Canadian pharmacies for two years. "We have had absolutely no complaints or problems associated with the program," said John Carnell, the city's risk manager. "There are no safety issues -- not a one."
Carnell said the city cut its pharmaceutical-buying budget by $500,000 in the first year, from $1.8 million to $1.3 million.
Another leader in the municipal caravan to Canada is Springfield, Mass., which launched its program in July 2003. Former mayor Michael J. Albano, who established the city's program and who now acts as a consultant to other communities, also insisted "that there are no safety issues."
"This is a popular program," he said. "It has consumer appeal and voter appeal."
But safety is central to concerns raised by the Maryland Pharmacists Association, which has opposed Montgomery's effort. "We fear the drugs will come from Third World countries," said Howard Schiff, executive director of the association. He said Canadian pharmacies "are importing drugs from other countries to fill prescriptions they have for export to the United States."
Council members said they were convinced that the county could design a safe program that would withstand legal challenge and save the county $15 million to $20 million a year.
There was little suspense about the outcome of the council's deliberations, because a majority of the nine members has been on record for many weeks in support of the initiative. The resolution passed 7 to 2.
Council member Michael L. Subin (D-At Large) voted against the measure. "I do not believe a body that makes laws should encourage others to go and break the law," he said.
The other opponent, council member Michael Knapp (D-Upcounty), stressed safety and the effect that the program might have on the county's biotechnology industry.
Patrick Kelly, vice president of the Biotechnology Industry Organization, expressed worry about the financial implications. "We are concerned that this signifies a growing willingness of government entities to consider imposing price controls on drug companies," he said in a statement.
Though the council in the past has approved resolutions critical of federal policies, Neal Potter, a former Democratic council member and county executive, said he could not remember another instance in which the county acted in apparent contravention of federal law. "It sets a precedent," he said, adding that he supports the council's action.
The current county executive, Douglas M. Duncan (D), on Monday gave his support to another council initiative to reduce drug costs, a discount card that will be available to all residents. Issued by a pharmacy benefits manager, the card lets individuals take advantage of the county's buying power, yielding discounts of as much as 20 percent below retail prices.
Duncan has said he opposes implementing a program that would violate the law and has requested that the state ask the FDA to issue a waiver that would allow Montgomery to go ahead with its plan to import drugs.
Nelson Sabatini, secretary of the state Department of Health and Mental Hygiene, expressed doubt about the request. "I do not know there is such a thing as a waiver, and I do not know what authority the FDA has" to grant a waiver, he said.
In the case of the Municipal and County Government Employees Organization, a union for county workers, it will fall to Duncan to negotiate language allowing union members to import prescription drugs from Canada. Gino Renne, president of the union local, said that his organization supported the council's action but that it creates a Catch-22 for Duncan.
Wes Girling, director of benefits for Montgomery County public schools, said the school system would move immediately to begin soliciting bids from vendors to import prescription drugs. "This is really a framework for us to go forward," Girling said. "I look at it as the big picture blessing to proceed."