FDA delays response to prescription drug lawsuit

The Food and Drug Administration has postponed its response to Vermont’s first-in-the-nation lawsuit seeking to overturn the FDA’s ban on the importation of prescription drugs from Canada.

The agency now has until Nov. 30 to respond.

“We believe we need additional time to consider the state’s allegations,’’ said Assistant U.S. Attorney Joe Perella, the Burlington-based federal lawyer handling the case.

Gov. James Douglas and Attorney General William Sorrell in August filed a complaint in U.S. District Court in Burlington opposing the FDA’s denial of a pilot program that would have allowed 20,000 state employees, retirees and their families to buy prescription drugs from Canadian pharmacies.

“We look forward to the FDA’s response at the end of the month,’’ Jason Gibbs, Douglas’ chief spokesman, said Tuesday. “The governor remains very confident in the case the state has presented, and he looks forward to resolving this issue and offering Vermonters access to lower cost prescription drugs.’‘

Vermont became the first state to sue the FDA over drug reimportation. Douglas’ decision to do so sparked a political controversy over whether he was doing enough to address the issue. His Democratic challenger, Burlington Mayor Peter Clavelle, established the state’s first drug reimportation program through which city employees can seek their prescription drugs from Canada for up to 50 percent less than on this side of the border.

Unlike Clavelle and several of his gubernatorial counterparts, Douglas declined to defy current federal law, deciding instead to work through the courts. “Real leadership means changing laws that you disagree with,’’ Gibbs said.

The FDA has steadfastly refused to approve drug reimportation programs, citing safety concerns. Many have called that argument disingenuous, and point to the Bush administration’s strong ties to the pharmaceutical industry, which also opposes allowing Americans to purchase drugs from other countries.

Provided by ArmMed Media
Revision date: June 18, 2011
Last revised: by Andrew G. Epstein, M.D.