OSTON,
Aug. 10 - Vermont will become the first state to sue the federal
Food and Drug Administration for rejecting a plan to import
prescription drugs from Canada, the state's governor and
attorney general said Tuesday.
Reacting to intense pressure to help make prescription drugs
more affordable, Vermont officials had asked the drug agency in
November to approve a pilot program under which the state would
contract with a Canadian company that would take orders from
Vermont residents and distribute the drugs by mail.
On Monday, state officials received a letter from the drug
agency denying the request, saying the government could not
ensure the safety of drugs from Canada.
Other states, including Illinois, have received similar
denials, but no other state has sued the F.D.A.
"The claims on which they've based this denial are, in
our view, unsubstantiated, and we have no choice but to pursue
any and all legal remedies available," said Gov. Jim
Douglas, a Republican, in a statement late Tuesday.
The state's attorney general, William H. Sorrell, said:
"Vermont's petition was carefully crafted and reasonable. I
am amazed that the F.D.A. rejected it, but I am looking forward
to getting this in front of a federal judge."
States across the country have been trying to figure out ways
to allow their citizens access to lower-priced Canadian drugs.
Two dozen legislatures have passed or are considering bills to
allow such programs, said Richard Cauchi, a health program
director with the National Conference of State Legislatures.
But while a few cities, like Springfield, Mass.; Montgomery,
Ala.; and Burlington, Vt., have started programs that import
Canadian drugs, most state governments, faced with warnings from
the F.D.A., are treading carefully. Minnesota, New Hampshire,
North Dakota and Wisconsin have set up Web sites that link
consumers in their states with Canadian pharmacies so consumers
can buy drugs on their own.
New Hampshire's governor, Craig Benson, a Republican, said
late last year that his state would import Canadian drugs for
prison inmates, retired state employees and Medicaid recipients,
but the program has not yet begun. And Illinois's governor, Rod
R. Blagojevich, a Democrat, who has projected that his state
could save $91 million by buying Canadian drugs, has said he
will not act without federal approval.
In February, an Illinois couple filed a federal lawsuit
against the drug agency and the secretary of health and human
services, but Vermont, which expects to file its lawsuit within
a week, will be the first state to take the federal government
to court on the issue.
Jason Gibbs, a spokesman, said Governor Douglas was
determined to "work within the system and within the limits
of current law to implement a program."
Vermont's proposal would have initially allowed the state to
import Canadian drugs for current and retired state employees
and their dependents, with a goal of expanding the plan to cover
other Vermonters, Mr. Gibbs said.
He said the pilot program was projected to save the state
about 5 percent of the $18 million it spends on prescriptions
for state employees and retirees.
Mr. Gibbs said the Vermont proposal should have satisfied the
safety issues because it "called specifically for the F.D.A.
to work with us to address safety concerns."
But in denying Vermont's petition, William K. Hubbard, the
agency's associate commissioner for policy and planning, wrote
that "it would be extremely unlikely that the State of
Vermont could ensure that all the Canadian drugs" would be
"in full compliance with all laws and regulations
applicable to F.D.A.-approved drug products and were safe and
effective."
A spokeswoman for the drug agency, Kathleen Quinn, said it
was "a little premature for us to be commenting on a
lawsuit that hasn't been filed, but as always F.D.A. is
concerned about the safety of drugs coming into the United
States."
Mr. Gibbs said that while the lawsuit was pending, Vermont
officials would meet with New Hampshire officials and consider
adopting that state's proposal to start importing Canadian drugs
for some beneficiaries of state health care coverage.
And in a letter Tuesday to the drug agency, Michael K. Smith,
the Vermont secretary of administration, wrote that the state
would be "forced to consider development of a reimportation
program that conforms to our interpretation of the current laws,
independent of your agency."