Illinois Governor Defies FDA Rule on Drug Importation
Illinois plans to become the first state to directly help residents buy prescription drugs from Europe. The state plans to launch a Web site for residents to buy name-brand drugs from Ireland, the United Kingdom, and Canada. Gov.
Illinois plans to become the first state to directly help residents buy prescription drugs from Europe. The state plans to launch a Web site for residents to buy name-brand drugs from Ireland, the United Kingdom, and Canada.
Gov. Rod Blagojevich (D) announced plans to create the Web site and a network of overseas pharmacies to fill orders on August 17. He made his announcement with Rep. Rahm Emanuel (D-Illinois), a former Clinton administration advisor whose congressional district includes part of Blagojevich's former congressional district.
Blagojevich's action stands in defiance of the U.S. Food and Drug Administration (FDA), which prohibits citizens from buying prescription drugs from overseas. It also came as news to officials in Ireland, who say they never have been approached by Illinois state officials about buying prescription drugs.
Big Surprise to Ireland
A spokeswoman from the Irish agency principally involved with licensing and regulating prescription drugs there told the Chicago Tribune on August 19 the agency could not comment because it had no knowledge of Blagojevich's plan.
"It just seems unusual, very unusual," said Siobhan Molloy, a spokeswoman for the Irish Medicines Board, Ireland's equivalent of the FDA. "We haven't come across it before. We don't know the details at this point."
The three main firms that distribute drugs in Ireland also said they know nothing of the plan and would in fact have no interest in participating.
"There would be too many issues concerning labeling and approval that would create difficulties in trying to have drugs licensed and sold in Ireland for sale in the United States," Pauline McAlester, a spokeswoman for United Drug, told the Chicago Tribune.
Dublin's Sunday Tribune quoted Patrick Tracey, managing director of drug wholesaler Cahill May Roberts, who also said his firm had not been approached about the plan and would not participate if asked.
A spokesman for another large Irish wholesaler, UniPhar, said he knew of no contact with Illinois officials.
And Anne Nolan, chief executive of the Irish Pharmaceutical Healthcare Association, said her organization would not be happy with the arrangement. "It would cause enormous problems for us to meet our local obligations here," she said.
Potentially Large Legal Problems
Nearly a year ago, Blagojevich began lobbying the FDA for approval to help the state's residents buy drugs from Canada. The FDA opposed the request, and Blagojevich helped organize a class-action lawsuit to give senior citizens across the nation access to drugs from Canada.
Because Canada and the European countries impose price controls on pharmaceuticals, many drugs in their markets cost less than those sold in the United States. Blagojevich said he believes the Illinois state government could save $50 million buying drugs from overseas for employees, retirees, and others on state health plans; he estimates Illinois residents collectively could save nearly $2 billion more.
FDA officials are looking none too kindly on Blagojevich's announcement.
"These are clearly going to be illegal drugs. We've aggressively prosecuted commercial operators but haven't taken action against public officials, although it may come down to that," said William Hubbard, the FDA's associate commissioner for policy and planning.
Blagojevich said he does not worry about possible legal action, pointing out the FDA has taken no action against states that help residents buy drugs from Canadian pharmacies, including Minnesota, New Hampshire, North Dakota, and Wisconsin. The Illinois plan is new in that it broadens the reimportation program to include Europe.
Hubbard said the FDA has several concerns about the Blagojevich plan and earlier state efforts, chief among them possible drug counterfeiting or tampering.
"With the system in this country, counterfeiting is rare," Hubbard said. "In some countries more than half the drug supply is fake. We know those suppliers would love to get into our market because it's so rich. Our counterfeiting cases have tripled to 21 in the last three years. That tells us counterfeiters are knocking on the door. Any program that gives them entree troubles us.
"The common answer we get is that most of these drugs are made in the U.S. or Canada. But many aren't. We also know that Canadian pharmacies have been running short (because of U.S. demand for their drugs) and accessing drugs from other countries.
"Our concern about the U.K. is that while they have a good regulatory system, they have parallel trade. Drugs can move freely from any country to another. That means as a practical matter, they can be buying from Latvia, Estonia, or other countries without a sophisticated regulatory system."
Wanda Moebius, spokeswoman for the Pharmaceutical Research and Manufacturers of America (PhRMA), said, "it's unfortunate Illinois is pursuing this illegal and risky scheme."
She said unapproved drugs from approved sources have been found in Minnesota and Wisconsin, which have state-run programs that allow residents to buy drugs from Canada.
What? Me Worry?
Blagojevich has no such worries, and in fact has said he believes that in some ways drugs from outside the country are safer than those here. He bases that opinion on a report by a team of experts he sent to Canada one year ago to study the possibility of importing drugs from that country.
"The group reported that importing prescription drugs from Canada is not only safe, but in some cases, even safer than purchasing prescription drugs here in the United States," according to the governor's announcement. But the governor's team failed to meet with representatives of Health Canada, the Canadian counterpart to the U.S. FDA. Health Canada has said it cannot ensure the safety of drugs sent to U.S. consumers from Canada.
The governor's push to bring in drugs from Europe in addition to Canada began last May, when Blagojevich sent a delegation that met with government, pharmaceutical, and health industry representatives in Belgium, France, Germany, Ireland, the Netherlands, and the United Kingdom. The delegation concluded Illinois could establish a network of foreign pharmacies that would meet state standards and provide drugs at much lower prices.
The Illinois program would be restricted to about 100 of the most commonly prescribed name-brand drugs used to treat chronic or long-term conditions. Only prescription refill orders will be placed.
The London Telegraph reported September 6 that Blagojevich's plan to help Illinoisans buy prescription drugs from Ireland via Great Britain may not fly because British pharmacies may dispense prescriptions only when they have a physician's signature in ink.
Rich Miller, writer of Capitol Fax, a popular political newsletter in Illinois, followed up on the Telegraph article and reported the statute governing drug sales in Britain, listed under National Health Service (General Medical Service) Regulation 3(2), Schedule 2, Paragraph 44(2), states:
"In issuing any such prescription form the doctor shall himself sign the form in ink with his initials, or forenames, and surname in his own writing and not by means of a stamp, and shall so sign only after particulars of the order have been inserted in the form."
As Miller noted in his September 7 Capitol Fax: "A pilot program for electronic prescription form signatures was begun in 2001, but that wouldn't cover Illinois' project unless the governor could somehow sweet talk the British bureaucracy into going along with his idea. Barring that, it's doubtful the governor's people could convince a British doctor to personally sign thousands of individual prescription forms every week."
Miller also notes Illinois officials failed to meet with important public health officials in Great Britain, despite an 85-page report issued in June by Blagojevich's "Office of the Special Advocates for Prescription Drugs" that recommended using a Web site to facilitate the importation of drugs from Europe.
"A closer look at the list [of persons the special advocates met] turns up only one person with the British National Health Service--Duncan Hill," according to Miller's report. "Mr. Hill is a 'local facilitator' in Glasgow, Scotland, whose job is to link 70 'pharmacy practitioners with local health promotion personnel.'"
Plan Could Overwhelm Market
To participate in the Blagojevich program, doctors will have to fax or patients will have to mail an original prescription to a clearinghouse, where it will be reviewed for appropriateness and turned over to a program physician for review. If that physician approves, the prescription will be rewritten and submitted to a pharmacy in a network established by a pharmacy benefits manager hired by the state.
Blagojevich said the Illinois Department of Public Health and the Department of Public Regulation will work with the benefits manager to inspect network pharmacies to ensure they meet the state's pharmaceutical safety standards.
If all Illinois residents used the program to purchase medications available through the Web site, total projected savings could reach $1.9 billion in the first year, according to the governor's office.
But with 12.6 million residents, under that scenario Illinois would account for half the Canadian drug market, overwhelming it, said John Graham, adjunct scholar with the Fraser Institute, a Canadian think tank. Graham noted drug makers already have been limiting shipments to Canada because of U.S. demand.
"The ability of individuals in the U.S. to buy from Canadian pharmacies is collapsing," Graham said. "This [Illinois plan] is a short-term mechanism. It's something of a mystery how these gray-market pharmacies are getting their drugs, because the drug makers won't supply them directly. [The gray-market pharmacies] will send to other pharmacies a note saying 'we'll buy from you for a markup and then resell.' It's drug arbitrage."
Graham also said the Illinois Web site is unnecessary because "anyone can real easily find a Web site selling Canadian drugs. If Illinois' governor wants to impose price controls in the U.S., and it sounds like he does, he should bring that forward explicitly and allow the public debate to occur. If price controls are going to be imposed, they ought to be imposed by legislators elected by U.S. citizens and not by legislators in Canada, the U.K., or Ireland."
At least three bills to allow the purchase of drugs from overseas are pending in the Illinois Senate, and one is pending in the House.
Steve Stanek (firstname.lastname@example.org) is an Illinois-based freelance writer and regular contributor to Health Care News.