Maryland’s Montgomery County Sues FDA To Allow Pilot Prescription Drug Reimportation Program
Montgomery County, Md., on Thursday filed a lawsuit in U.S. District Court in Greenbelt, Md., alleging that FDA unfairly denied its request to allow county residents to purchase medications from Canada, the Washington Post reports. County Executive Douglas Duncan, a democratic candidate for governor, announced the suit, which comes more than one year after the county council first raised the issue. Despite objections from Duncan, the Montgomery County Council approved a resolution calling for a program to allow 85,000 current and retired county employees and their dependents to be able to purchase drugs without federal approval. Duncan decided to seek a waiver from FDA rather than implement the program. Montgomery County officials plan to emphasize in court that many other cities and states have begun reimportation programs without federal approval. The lawsuit seeks a court order to allow the county to establish a reimportation pilot program (Craig, Washington Post, 2/24). The program initially would allow only county employees to buy their drugs from Canada and could be expanded later to all county residents, depending on its success. According to county Attorney Charles Thompson, the county spent about $24.5 million on prescription drugs for its employees and retirees in 2005, and purchasing drugs from Canada would save 20%, or more than $4 million annually (Higgins, Washington Times, 2/24). Montgomery County's lawsuit "could be a symbolic test case of the federal government's importation policy" because FDA is based in Rockville, Md., a town in Montgomery County, according to the Post. FDA has been sued twice before on the issue, once by Vermont and once by private citizens from Illinois. Both suits were dismissed.
"The whole point of (the lawsuit) is to get cheaper medications into the hands of those who need them most," Duncan said (Washington Times, 2/24). He added, "The Bush administration has totally politicized the FDA. Decisions are no longer based on science or public health but rather on politics." Thompson said, "If they are not doing something to stop the reimportation of drugs, we have to believe the FDA believes it is safe." Montgomery County Council member Tom Perez, who wrote the resolution calling for the county employee reimportation program, said, "We shouldn't be asking for permission. ... There are so many other jurisdictions that have really taken the bull by the horns and moved forward." Ken Johnson, senior vice president at the Pharmaceutical Research and Manufacturers of America, said that the lawsuit is "playing Russian roulette with people's health" (Washington Post, 2/24). FDA spokesperson Rae Jones said the agency had not received the suit and would not comment on any pending litigation. Bill Hall, an HHS spokesperson, said the agency would not comment on any legal matters but added, "[W]e have continued to resist any attempts to put any systems in place for reimportation of prescription drugs because we cannot vouch for the safety of what people may be buying from other countries" (Washington Times, 2/24).