Montgomery to Sue FDA on Drug Imports

Montgomery County Executive Douglas M. Duncan (D) announced yesterday that the county will sue the Food and Drug Administration to force it to allow county employees to import drugs from other countries.

The move comes in response to the FDA's denial this week of Duncan's request for a federal waiver to set up a pilot drug importation plan in Montgomery.

Duncan filed the request last month as the County Council pushed ahead with plans to give employees, retirees and dependents the option of buying cheaper foreign drugs.

The FDA, which is based in Rockville, has long maintained that Canadian drugs are neither safe nor legal. The agency has repeatedly warned that it could sue the county if employees began obtaining drugs from Canada.

In issuing its denial letter Tuesday, the FDA noted concerns that some drugs that are supposed to be made in Canada originate in such countries as India and Costa Rica.

"We cannot provide adequate assurance to your constituents that the drug products delivered to them from foreign countries" are safe, wrote Randall W. Lutter, acting FDA associate commissioner for policy and planning.

County Attorney Charles W. Thompson Jr. said the county will file suit in federal district court within two weeks to get the denial overturned. Thompson said the suit will be brought on the grounds that the FDA dismissed the waiver "without giving it fair consideration."

"I am disappointed, but not surprised, that the Bush Administration would deny hard working people access to cheaper prescription medications," Duncan said in a statement.

The county's lawsuit faces long odds. In late September, a federal judge threw out a similar action brought by Vermont. On Nov. 2, that state's attorney general decided not to appeal.

Duncan's decision to sue is his latest attempt to stave off implementation of a Canadian drug program without FDA approval.

In September 2004, the County Council approved a resolution urging the county government, school system and planning department to participate in a Canadian drug program.

The council has contracted with Canusa Health Group, a privately held health benefits company based in Windsor, Ontario, to obtain and distribute the drugs.