Vermont Files Suit Against FDA Over Drug Reimportation

Vermont Files Suit Against FDA Over Drug Reimportation
Montpelier, Vt. - The State of Vermont this afternoon (Thursday Augst 19, 2004) formally filed suit
against the Food and Drug Administration (FDA) in U.S. District Court in
Burlington, Vermont, becoming the first state in the nation to challenge
the FDA's legal arguments for blocking reimportation proposals.
"Vermont will not sit back and watch as the cost of health insurance and
prescription drugs continues to rise. Nor are we content to simply ignore
the law," Governor Douglas said. "Real leadership means challenging those
laws and policies you oppose, and working within our systems to change
them. It is our hope and expectation that Vermont's leadership will result
in a legal precedent that benefits every Vermonter, and every American."
Governor Douglas acknowledged that the cost of prescription drugs is but
one piece of the problem, and reimportation one part of the solution. As
he has done many times before, Douglas said he would continue to urge
Congress to take immediate action to increase competition among
manufacturers, speed the approval of generic drugs, preserve states'
ability to pool their purchases, protect state pharmaceutical programs
that may be impacted by the new Medicare law, and review recent increases
in the cost of pharmaceuticals.
"Reforming the American pharmaceutical marketplace must be our top
priority," he said. "The ultimate goal is to get the best possible market
prices at our pharmacies here at home."
The complaint argues that the FDA decision was "arbitrary and capricious,
and otherwise unreasonable" and in direct violation of the Medicare
Prescription Drug, Improvement, and Modernization Act (MMA) of 2003. The
MMA requires the federal government to create rules permitting
reimportation of prescription drugs by wholesalers, pharmacists, and state
benefit programs, and to issue guidance describing the circumstances under
which the FDA will grant waivers allowing reimportation for personal
use-neither of which the FDA has done.
According to the complaint, Vermont is seeking a court order that will
"require prompt adoption of regulations and waiver guidance and
appropriate consideration of Vermont's proposed program."
Vermont had sought a waiver from the FDA authorizing a pilot drug
reimportation plan. The goal of the pilot project was to demonstrate how
a plan could be safely implemented, and ultimately serve as a model for
other states to implement similar programs.
Douglas and Attorney General William Sorrell agreed the suit was
necessary, saying the federal government's grounds for denying the waiver
request are not legitimate.
"Vermont presented a legal and responsible plan to import prescription
drugs," Governor Douglas said at the time of the FDA rejection. "The
claims on which they've based (the) denial are, in our view,
unsubstantiated and we have no choice but to pursue...all legal remedies
available."
After the complaint has been filed with the court and served on the
federal government, the federal government has 60 days to respond.
A copy of the complaint is available at:
http://www.vermont.gov/governor/priorities/priorities.html