Experts find FDA’s safety objections unfounded
CHICAGO – Gov. Rod R. Blagojevich was joined by U.S. Rep. Rahm Emanuel (D-Chicago) today as he released the findings of a study he commissioned in mid-September on the potential cost-savings and feasibility of reimbursing state employees and retirees for prescription drugs purchased from Canada, where prices are significantly lower. Illinois’ team of pharmaceutical and regulatory experts found that – if the federal Food and Drug Administration approved – the state could set up an importation system with safety checks equal to or greater than Illinois’ current pharmaceutical system and achieve savings of up to $90.7 million.
The results come at a critical time when the U.S. Congress is negotiating the final language of a Medicare package and the FDA is under increasing pressure to let states and local governments design prescription drug plans that include cheaper drugs from other countries. Blagojevich and Emanuel will use the report to demonstrate that major savings could be realized by including an importation provision similar to that contained in the Emanuel-sponsored Pharmaceutical Market Access Act that was passed by the House earlier this year.
“We suspected that consumers could save money if we imported prescription drugs from Canada, but we didn’t expect the savings would be this significant. And we suspected that the Canadian procedures for distributing, labeling and handling prescription drugs were safe, but we didn’t expect them in some cases to be even safer than the procedures we use here in the United States. Our report shows – when you study the issue and look at the facts – the FDA’s excuse of safety is a red herring,” said Blagojevich.
“I hope that the Medicare conferees in Washington look carefully at the results of this study, and realize that drug importation can make a difference in the type of Medicare benefit we can offer, and make a difference in the burden on taxpayers and states," Emanuel said. “This study validates what millions of Americans already know - taking advantage of world market prices for prescription drugs saves money.”
After six weeks of intensive research and meetings with stakeholders in the pharmaceutical importation issue – including pharmacists and regulators in the U.S. and Canada, Canadian health officials, representatives of the pharmaceutical manufacturing industry, consumer groups and the FDA – Illinois’ Special Advocates on Prescription Drugs released an 85-page report outlining their findings.
The State of Illinois and its employees and retirees could realize a combined savings of $90.7 million annually if all eligible prescriptions were filled through a Canadian Mail Order Plan. Employees and retirees enrolled in the plan using three prescriptions a month would save up to $1,008 per year on their prescription co-payments. The burden on taxpayers who fund the state’s prescription program would be reduced by $56.5 million, down 16.6% from last year’s cost of $340 million.
In addition, the report indicates that Canada’s drug regulation and distribution systems meet American standards in every way.
· The Canadian regulatory system provides health and safety protections that are substantially equivalent to those provided in the State of Illinois.
· Drugs sold in Canadian pharmacies are manufactured in facilities approved by Health Canada.
· Though not identical in statutory and regulatory text, both countries' methods of ensuring safety and efficacy of prescription drugs are comparable.
· The United States and Canada have comparable requirements at virtually every level for the warehousing and storage of pharmaceuticals.
· The educational requirements for licensed pharmacists in the Canadian provinces visited - Ontario and Manitoba - are as rigorous as those of Illinois.
· The professional regulation of pharmacists in Ontario and Manitoba appear to be as rigorous as professional regulation of pharmacists in Illinois.
· Reporting of incidents involving internal process errors was more rigorous in Manitoba and Ontario than in Illinois.
· Canadian pharmacies fill prescriptions in amounts supplied by the manufacturer in sealed containers only. They do not open manufacturer supplied containers, count and repackage to fill the prescription as done in US. This provides an added measure of safety.
The report’s findings on the safety of Canada’s system reinforce the position of Gov. Blagojevich, Rep. Emanuel and other elected officials who have been pushing to open the Canadian market to American consumers. Already, more than one-million Americans a year buy their medications from Canada, and the FDA cannot cite a single incident of harm or death resulting from problems with Canadian drugs.
“And so today, based on the findings of this report, I am sending a letter to the FDA and to the U.S. Department of Health and Human Services, formally requesting that they permit the State of Illinois to import prescription drugs from Canada. I hope they say yes. But just in case, we will continue to work with Congressman Rahm Emanuel to help him in his efforts to pass legislation that directs the FDA to change its mind and reverse its policy. It’s time the FDA stops protecting the big drug companies, it’s time they start helping people,” said Blagojevich.
In addition to formalizing his request to HHS and the FDA, Blagojevich also renewed his call for American consumers to join him in pressing the federal government to open access to lower prescription drug prices by reversing its position on drug importations. Earlier this month he launched a website and on-line petition at www.affordabledrugs.il.gov
, and a toll-free number 1-866-296-6322, to give the public a forum for voicing their support for legalized prescription drug importation.
“If you think you should be allowed to buy your medicine at a lower price – let the FDA know.
Log on to our website – sign our electronic petition – and let your voice be heard. Let the FDA know that they work for you. You don’t work for them,” Blagojevich urged.