- The Washington Times - Tuesday, September 21, 2004

Montgomery County — home to the U.S. Food and Drug Administration — paved the way yesterday for a plan to buy prescription drugs from Canada despite FDA warnings that it would be breaking the law.

The Montgomery County Council passed a resolution by a 7-2 vote that instructs county benefits managers to solicit bids from companies that sell Canadian prescription drugs to American consumers. The council hopes to have the program in place by Feb. 1.

The county would join several other states and jurisdictions that have turned to Canada and other foreign countries to try to limit the exploding cost of prescription drugs for public employees.

Several council members who voted for the resolution were emboldened by the FDA’s failure to file lawsuits in those cases, saying it is a sign the agency is reluctant to back up its claims that those programs are illegal.

“The credibility of the FDA is being called into question,” said council President Steven Silverman. “They can’t have it both ways.”

The FDA, headquartered in Rockville, has sent warning letters to governments that have adopted similar plans and has filed legal action against some suppliers.

The agency says it can’t verify the safety and origin of drugs sent from overseas and that some medications might be bogus or unsafe. The warning letters stress that local officials could be held liable if anyone is harmed by drugs sent from Canada.

William Hubbard, the FDA’s associate commissioner for policy and planning, said the agency still may file lawsuits for violations of the Food, Drug and Cosmetics Act, which prohibits the importation of drugs from foreign countries in most cases.

“We have held our fire thus far, but we may have to end up suing a county,” he said. “They [Montgomery County officials] have undermined their oath to uphold the nation’s law. If we end up suing, I think we would win.”

Montgomery’s plan would allow the 85,000 employees, retirees and their dependents from several different county agencies to buy prescription drugs through the mail from a Canadian supplier.

The program would be cost-free to the user and optional. Only maintenance drugs, which come in 90-day supplies, would be included. Drugs that are temperature sensitive or require special storage would not be included.

The county expects to reap significant savings from the plan. Montgomery spends about $70 million on prescription drugs each year for employees, retirees and their families. If all employees take part during the first year, the county predicts it will save up to $16 million.

The resolution is not binding, but benefits managers for the county schools, the county parks division and other agencies said they would put out a joint solicitation for bids on a contract.

In the case of the county schools, the largest employer in that bloc, the union contracts already include language that make it possible to buy Canadian drugs, according to benefits manager Wes Girling.

Montgomery County Executive Douglas M. Duncan and Mr. Silverman had asked Gov. Robert L. Ehrlich Jr. to seek an FDA waiver that would allow the county to go ahead with the plan without fear of legal action.

However, FDA officials said they did not have the authority to grant such a request.

Mr. Duncan said yesterday he had not heard back from the governor’s office or the FDA. But he said he was still concerned about the legality of the program.

“It shouldn’t be, ‘If no one sues you it is legal,’” he said. “That is what I am hearing from the council.”

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