Vermont Will Sue U.S. for the Right to Import Drugs - NY Times

[Guest guest]

..

http://www.nytimes.com/2004/08/11/national/11drug.html?th

 

Vermont Will Sue U.S. for the Right to Import Drugs

By PAM BELLUCK

NY TIMES

Published: August 11, 2004

 

BOSTON, 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. "

http://www.nytimes.com/2004/08/11/national/11drug.html?th

 

=========

=========

..

..