Vermont to Sue FDA Over Drug Reimportation

Governor & Attorney General to Sue FDA Over Drug Reimportation
Montpelier, Vt. -- Governor Jim Douglas and Attorney General William
Sorrell announced August 10 that Vermont will file suit against the Food and
Drug Administration (FDA) in U.S. District Court over the issue of
importing drugs from Canada. Vermont is the first state in the nation to
sue the FDA for blocking a responsible reimportation proposal.
Vermont had sought a waiver from the FDA authorizing a legal 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 Sorrell agreed the suit was necessary, saying the federal
government's grounds for denying the waiver request are illegitimate.
"Vermont presented a legal and responsible plan to import prescription
drugs," Governor Douglas said. "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. We intend to file suit
shortly against the FDA in federal court."
"Vermont's petition was carefully crafted and reasonable," said Sorrell.
"I am amazed that the FDA rejected it, but am looking forward to getting
this in front of a federal judge."
In response to the FDA's rejection letter, Administration Secretary
Michael Smith sent a strongly worded reply voicing the administration's
displeasure at the decision, and informing the FDA that Vermont would be
filing a lawsuit.
"Your failure to promptly issue regulations to provide for the safe
importation of prescription drugs from Canada, in accordance with section
1121 of the Medicare Prescription Drug Improvement and Modernization Act
of 2003, has compromised the ability of any state to adequately address
this important issue," Smith said in the letter. "We are, therefore,
forced to consider development of a reimportation program that conforms to
our interpretation of the current laws, independent of your agency."
In addition, Governor Douglas said he would dispatch the Commissioner of
Health, Dr. Paul Jarris; Commissioner of Human Resources, Cindy LaWare;
and his Legal Counsel, Susanne Young, to review New Hampshire's plan and
pursue a multi-state strategy to assist individuals who want to purchase
drugs in Canada.
Governor Douglas noted that reimportation is not a long-term solution and
said he would continue to urge Congress to take immediate action to reform
the American pharmaceutical marketplace.
"Congress should act immediately to legalize the reimportation of lower
cost drugs from Canada, increase competition among brand name
manufacturers, speed the approval of generic drugs, preserve states'
ability to pool their purchases and negotiate deep discounts with
manufacturers, protect state pharmaceutical programs that may be impacted
by the new Medicare law, and review recent increases in the cost of
pharmaceuticals," Douglas said. "The ultimate goal, of course, is to get
the best deal possible for Vermonters on their prescription drugs at local
pharmacies here at home."
Attorney General Sorrell serves as the President of the National
Association of Attorneys General. At that association's recent annual
meeting, Sorrell announced his presidential initiative to study and
recommend actions in response to the high cost of prescription drugs in
the United States. In commenting on today's developments, Sorrell stated:
"This action by the FDA underscores that, unless we take aggressive
actions, we are going to continue to pay the highest prescription drug
prices in the industrialized world."