CHICAGO – Growing frustrated with the Food and Drug Administration’s (FDA) failure to respond to Illinois’ request for permission to conduct a prescription drug importation pilot program, Governor Rod Blagojevich announced that Attorney General Lisa Madigan, today, will file a Citizen’s Petition with the FDA demanding a response within six months. The Governor’s petition is accompanied by affidavits from two health experts who have studied the safety of importing drugs from Canada.
“Every day, another Illinois senior is forced to ignore doctors’ orders and skip his expensive medications. Another parent has to put off buying new shoes for her children so her family budget can cover food and medicine. And all the while, the FDA sits back making symbolic gestures – an open mind and another study – but nothing gets done to help the people who can’t afford their drugs,” said Blagojevich.
“We’ve conducted the research. We’ve laid out the facts. And we’ve formulated a comprehensive plan to help our consumers get access to drugs they can afford from Canada. All we need is permission from Health and Human Services Secretary Tommy Thompson and FDA Commissioner Mark McClellan, and we’re ready to put the first pilot program in place for rest of the nation. But our appeals have fallen on deaf ears. So today we’re taking a formal step that requires the FDA to respond within six months, or we can take them to court.”
Citizen’s Petitions are allowed under Food and Drug Administration rules. Petitioners can request action or policy changes from the FDA. The agency is required to issue its decision in writing within six months, or the petitioner has cause to file suit in United States District Court. The petitioner can appeal the FDA’s response in federal court.
“Illinois families and residents continue to face skyrocketing prescription drug prices,” said Attorney General Madigan. “The safe importation of prescription drugs from Canada would help bring much-needed relief to Illinoisans who often are forced to choose between filling their prescriptions or filling their refrigerators. I’m committed to working with Governor Blagojevich in every way possible to lower drug prices.”
In the petition, Blagojevich renewed his request for the Secretary of Health and Human Services to certify that importing drugs from Canada can be done safely and cost-effectively. The petition also asks permission to establish one of several importation models outlined in the official request.
The FDA could allow pharmacists and pharmaceutical wholesalers to import Canadian drugs, and pass the savings on to their customers. Blagojevich’s petition asks the FDA to consider doing so either for all U.S. pharmacists and wholesalers, or for those in Illinois, or – on an even more limited, demonstration level – only for those that provide prescription drugs for individuals covered by Illinois state health plans.
Another set of options outlined in the Illinois petition asks the FDA to allow individual consumers to import drugs from Canada for their own personal use – a practice the FDA tolerates now, but that technically violates federal law. The FDA could permit all U.S. consumers to buy drugs from Canada, or it could limit permission to Illinois consumers or those covered by Illinois state health plans.
Included with Blagojevich’s petition were affidavits from two health experts with significant knowledge of the issues surrounding prescription drug importation. Alan Sager, PhD, a professor from Boston University’s School of Public Health and director of the university’s Health Reform Program wrote, “Prescription drug prices in the United States are the highest in the world and rising, with patients and payers in the United States providing the world’s drug makers with about one-half of their world-wide revenue. This is not a stable or sustainable arrangement. Importing prescription drugs from Canada offers a safe and effective way to lower prescription drug prices in the United States. There is little evidence of any genuine health threat arising from the importation of prescription drugs from Canada, which has stringent regulatory protections in place to ensure safety.”
Randall Stephenchew, a practicing Canadian pharmacist and former Health Canada Drug Specialist stated, “Health Canada’s drug regulatory system is considered to be one of the best in the world and further boasts one of the best drug safety records in the world… Prescription medications that come from Canada are equally as safe as the prescription medications being dispensed in the United States.”
The Governor also announced today that his Special Advocates on Prescription Drugs – Ram Kamath, PharmD., and Scott McKibbin – will be in Bethesda, Maryland, next week to testify before the FDA’s Taskforce on Prescription Drug Importation. The two advocates headed up Illinois’ comprehensive study of the feasibility and potential savings of importing drugs from Canada. Their findings showed that the State of Illinois and its employees and retirees could save nearly $91 million annually by buying some medications used for long-term conditions from Canada. They also found that Canada’s pharmaceutical distribution system is as safe, and in some cases safer, than the U.S. system.