Amercias New Drug Wars...FDA and Big Pharma.

mike65

Might the issue that decides the US presidential election be prescription drugs not war or jobs...?

BOSTON -- 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 for prescription drugs from Vermont residents and distribute them by mail.

On Monday, state officials received a letter from the drug administration denying the request, saying that the government could not ensure the safety of drugs imported from Canada.

Other states, including Illinois, have received similar denials, but no other state has taken the FDA to court over the issue.

"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 Sorrell, said: "Vermont's petition was carefully crafted and reasonable. I am amazed that the FDA 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 have started programs that import Canadian drugs, most state governments, faced with warnings from the FDA, are treading carefully.

Minnesota, New Hampshire, North Dakota and Wisconsin have set up Web sites that link consumers 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' governor, Rod 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.

Vermont's proposal would allow 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, spokesman Jason 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.

In denying Vermont's petition, William 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 FDA-approved drug products and were safe and effective."

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 on Tuesday to the drug agency, Michael 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."

We all have zillions of spam mails for cheap drugs from Canada I never actualy read them but its a real issue over there and one which looks set to become a touchstone for millions of elderly and low income ppl.

Still, thousands of packages containing prescription drugs pour into U.S. international mail facilities each year, government officials said, adding that it is impossible for border inspectors to check most of them.

"The growing volume of unapproved imported drugs ... presents a formidable challenge," said John Taylor, FDA associate commissioner for regulatory affairs.

Importing medicines is against the law, but Congress is considering creating a legal system to help senior citizens and others buy cheaper medicines from Canada and other countries.

Medicines bought online are part of the larger debate over drug imports, a growing election-year issue amid rising drug costs.

FDA officials say the practice is risky because regulators cannot assure drugs bought from abroad are safe and effective. Some consumers are seeking easy access to controlled substances that could potentially be abused, officials said.

Critics say the agency is exaggerating the risks to protect drug-industry profits.

"In our view, personal importation can never be made safe and effective," William Hubbard, FDA associate commissioner for policy and planning, said in an interview.

Hiring more border inspectors will not keep counterfeit or contaminated drugs from reaching U.S. consumers, Hubbard said. Inspectors cannot tell just by looking at a medicine whether it is legitimate, and chemical testing of all the products would be impractical, he said.

In separate action on Thursday, the FDA sent a second letter to the governor of Wisconsin urging him to take down a Web site that directs residents to Canadian pharmacies.

Mike.