County loses bid to reverse FDA rule

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ASSOCIATED PRESS

A federal judge has thrown out a lawsuit filed by Montgomery County that sought to overturn a U.S. Food and Drug Administration decision not to allow the county to import prescription drugs from Canada for public employees.

The ruling, filed Tuesday, leaves the county's plan to save money by letting workers and retirees buy cheaper drugs from Canada in limbo. Passed in November, the county decided not to implement it without a waiver from the FDA.

"We are reviewing it. We are checking our options, determining what the next step will be," county spokeswoman Donna Bigler said yesterday.

The county originally wanted to use the program for 85,000 workers and retirees from the county and other groups such as the school system. But concerns over the legality of the proposal pared that number to 12,500 county workers.

County Executive Douglas M. Duncan said he would implement the law only if the FDA agreed to give the county a waiver under the Medicare Prescription Drug, Improvement and Modernization Act. The FDA denied the request, saying it could not vouch for the safety of foreign drugs.

The county sued in February to overturn that decision, saying that the FDA's decision was arbitrary and that the federal law had provisions that allowed waivers.

But U.S. District Judge Alexander Williams Jr. in Greenbelt granted a motion by the FDA to dismiss the suit. Judge Williams concluded that the FDA followed the law when it rejected Montgomery County's request. He also said Health and Human Services Secretary Michael O. Leavitt, who oversees the FDA, was within his power to deny the waiver.

"The FDA's denial of the county's waiver request was mandated by federal law," Judge Williams wrote.

The case mirrors that of other jurisdictions, including Vermont, which had a similar waiver lawsuit against the FDA tossed out by a federal judge in September.