By DAVID ESPO, AP Special Correspondent

WASHINGTON - The Republican-controlled House approved a bitterly contested Medicare prescription drug bill early Saturday in an epic struggle settled near dawn. The vote was 220-215.

Passage of the measure capped an extraordinary roll call that began at 3 a.m. and consumed nearly three hours before the GOP leadership could overcome a rebellion by conservatives in their own ranks and the overwhelming opposition of Democrats.

"In the end, democracy works," said Rep. David Hobson, R-Ohio, as weary Republicans marked their overtime victory.

"We won it fair and square and they stole it by hook and crook," countered House Democratic Leader Nancy Pelosi.

The vote sent the measure to the Senate, where supporters expressed growing confidence they would prevail. President Bush is eager to sign the bill, which would give 40 million seniors and disabled Americans a prescription drug benefit and a new option for private health care coverage.

"After this legislation goes into effect, low-income seniors will never be confronted with the choice of putting food on the table or paying for life-saving prescription drugs," Speaker Dennis Hastert said well after midnight, just before the lights dimmed in the chamber to signal the beginning of the longest roll call in the history of the House.

But Pelosi said seniors know that her party gave birth to Medicare during the Great Society, adding, "we want to protect it and strengthen it. America's seniors have also known where Republicans stand, for four decades they have waged war on Medicare."

The bill represented a political compromise of sorts — the new prescription drug benefit, coupled with federal subsidies designed to give private insurance companies incentives to establish new managed care plans around the country.

Republicans said these new plans, either preferred provider organizations or HMOs, would modernize Medicare, providing better coverage at lower cost. Democrats expressed skepticism, saying they marked the first step on the road toward privatization.

Dozens of lawmakers, participants and spectators both, waited out the drama of the middle-of-the-night roll call, as Hastert, his lieutenants and Department of Health and Human Service Secretary Tommy Thompson shuttled from one GOP holdout to another seeking enough votes to prevail. GOP aides said Bush lobbied by phone from the White House.

The vote was stuck at 216 to 218 for over an hour, and the bill appeared on the verge of defeat, before a flurry of last-minute switches. "I did not want to vote for this bill," said Rep. C.L. (Butch) Otter, R-Idaho. He did, one of a handful of late GOP converts, He said afterward he became convinced that if the measure were defeated, another one would come back to the House floor even less to his liking.

The bill drew the support of 204 Republicans and 16 Democrats, many of whom waited until the bill appeared on the verge of passage in the final moments of the roll call before swinging behind it. Voting no were 189 Democrats, 25 Republicans and 1 independent.

Nearly 20 hours earlier, Republicans projected confidence, even bravado. "I look forward to the presidential signing ceremony," said California Rep. Bill Thomas, a key architect of a measure making the most sweeping changes in Medicare since the program's creation in 1965.

But that was before the near-solid wall of Democratic opposition, the stubborn refusal of conservatives to bend, the hours of debate, the behind-the-scenes lobbying, the presidential phone calls from Air Force One and the still-undisclosed deals made to secure passage.

"You'd think we were talking about different bills from the rhetoric we've heard this evening," said Rep. Deborah Pryce, R-Ohio, as the debate unfolded Friday night.

There was no disputing that.

"This is a defining issue," said Rep. Jim McGovern, D-Mass., as he made a case for rejecting the measure. "This bill is a huge giveaway to the prescription drug companies. And worst of all, this bill shoves Medicare down that path toward privatization."

"This bill is really all about a fair deal," countered Thomas, the chairman of the House Ways and Means Committee. "Modernize Medicare with prescription drugs, but put Medicare back on a sound financial basis as well."

As written, the legislation would virtually remake Medicare.

For the first time, seniors earning more than $80,000 a year would be required to pay a higher premium for their Part B non-hospital coverage under Medicare.

For the first time, the legislation would also require seniors with annual incomes over $80,000 to pay higher premiums under Medicare Part B, which covers services outside the hospital. Additionally, it would establish new tax-preferred health accounts, open to individuals with high-deductible insurance policies.

The tax provision and the requirement for higher premiums were part of an effort to appeal to conservatives who favor transforming Medicare and restraining its cost, yet find creation of the new prescription drug benefit distasteful.

Many Democrats argued that some of the conservative-backed elements of the bill were too dear a price to pay for the drug benefit — particularly a provision creating a limited experiment in direct competition between private plans and traditional Medicare beginning in 2010.

Conservatives said just the opposite.

Rep. Tom Feeney, R-Fla., fielded an afternoon phone call from Bush, who was flying home from England aboard Air Force One. "I basically said it was a matter of principle, that I came to Washington not to ratify and to expand Great Society programs," said the first-term lawmaker. "He wasn't happy to hear that."

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By Randall Palmer

OTTAWA (Reuters) - The top U.S. drug regulator called on Canada on Tuesday to do more to counter the sales of cheap prescription drugs into the United States, but the plea fell largely on deaf ears, with Ottawa saying the issue was a essentially a domestic U.S. problem.

The remarks were made in Ottawa against the backdrop of an increasing flow of lower-cost prescription drugs from Canada to individual Americans -- notably hard-pressed seniors -- and calls by city and state governments in the United States to follow suit in order to lower the cost of expensive medical plans.

"Our concern is that this system in Canada, that assures drug safety in Canada, is not set up to assure the safety of large volumes of drugs shipped over the Internet from unregulated or poorly regulated sources to Americans," said Mark McClellan, head of the U.S. Food and Drug Administration.

His Canadian counterpart, Assistant Deputy Minister of Health Diane Gorman, has taken the position that it was primarily a problem for Washington to deal with, not Ottawa.

"My responsibility is to make sure that Canadian law ... is respected. The U.S. FDA is sharing some information with us. We are investigating a number of issues that they've brought to our attention," she told a news conference.

But she added: "At this point in time we don't have evidence of Canadian law being broken."

Reflecting on her view, McClellan said: "Maybe what Diane is saying ... is that there are not any real safety issues at the moment for Canadians.

"I think there are other Canadians who would dispute that -- for example all the (provincial) regulators who do see some real safety risks for Canadians too."

Some Canadian pharmacists have voiced concern that supplies from foreign drug manufacturers may be held back in an attempt to choke off the Internet pharmacies. They have also said it was unethical for Canadian doctors to sign off on U.S. prescriptions without seeing the patients.

"I think it is clear ... that there is a way for Canadian government officials to take more actions to assure the safety of these products," McClellan said.

McClellan and Gorman were speaking after signing a memorandum of understanding on exchanging information on a wide range of topics, most prominent of which was the issue of Internet pharmacies.

The agreement appeared to be aimed, at least partly, at bridging the U.S.-Canadian gap on whether there is a problem of safety and supply of the prescription drug sales.

"We have no evidence at this point in time in the case of Internet pharmacies of unsafe products going to the United States," Gorman said.

In a speech before the two officials spoke to reporters, McClellan also called on Canada and other developed countries -- which all set drug prices lower than in the United States -- to share more of the burden of developing drugs.

"If all we do is focus our efforts on getting lower prices, then all that we will end up paying for is the cost of making and distributing the pills themselves," he said, which would leave development costs for Americans and others to pay.

"This isn't a sustainable situation. We need fairer and better ways to encourage the development of better medicines," he said.

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The bodies that regulate pharmacies across Canada are calling on the federal government to ban the cross-border sale of prescription drugs to the United States, arguing they cannot police druggists whose customers are in a different country.

Some of those customers have already lodged complaints against Canadian pharmacies, creating difficult challenges for the regulators, said the National Association of Pharmacy Regulatory Authorities.

The body is also concerned about possible shortages of drugs and pharmacists for the Canadian market as a result of the cross-border business.

Coming from a group of apolitical professional organizations, the association's call for a ban is the strongest assault yet in Canada against the burgeoning, but controversial, export industry.

"There are increasing questions and reports on drug shortages," said Barbara Wells, executive director of the umbrella group for provincial and territorial agencies.

"It just stands to reason that if we are going to be supplying the U.S. market, this is just the tip of the iceberg."

However, the groups believe the trade might eventually be viable if a system can be created to permit international regulation, Ms. Wells added.

The request that Health Canada shut down the business at least temporarily was endorsed yesterday by the U.S. Food and Drug Administration, which is strongly opposed to the importation of prescription drugs.

A ban is absolutely necessary, Tom McGinnis, the FDA's director of pharmacy affairs, said in an interview. "It's illegal."

Mark McLellan, the agency's commissioner, is scheduled to visit Health Canada officials in Ottawa on Tuesday to discuss the issue.

The pharmacy regulators' statement got a much different reception from the mail-order pharmacy business, which has grown within barely a year to sell as much as $1-billion of medication to the United States annually.

The declaration was a "ridiculous and rash, draconian step," said David Mackay of the Canadian International Pharmacy Association.

He noted the regulators in at least one province, Manitoba, have specifically agreed to oversee the international business, even drawing up special standards for it.

"To suggest all of a sudden that the regulatory authorities cannot stand by these agreements is an indictment of themselves," Mr. Mackay said. "It's saying their own system is incompetent."

In Manitoba, where the bulk of the mail-order pharmacies are located, fees from such businesses to the regulator, the Manitoba Pharmaceutical Association, total more than $700,000 a year, he said, allowing them to hire extra staff. Despite repeated inspections, no transgressions have been uncovered, Mr. Mackay said.

But there appears no immediate threat that Health Canada will take up the national regulatory association's suggestion.

"It is premature to consider banning export of prescription drugs because there is no evidence of drug shortages related to Internet pharmacy," said Krista Apse of Health Canada.

"Our bottom line is to ensure that Canadians continue to have access to affordable, safe drugs when they need them."

Still, the department will continue to monitor the situation closely, she said.

The regulatory association's members licence pharmacists, investigate complaints and mete out discipline when necessary. The Manitoban regulator has already received some complaints from the United States, although no more, proportionately, than it would normally get from Canadian pharmacy customers, she said.

But officials worry about their ability to subpoena witnesses from the United States, if necessary, or obtain confidential medical information from south of the border, which might be needed in an investigation of alleged wrongdoing, she said.

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Associated Press

WINNIPEG, Manitoba (AP) - More U.S. politicians will start looking to Canada's Internet pharmacies as a way to save money on costly prescription drugs south of the border, Minnesota Gov. Tim Pawlenty predicted Wednesday.

"I think you're going to see more governors, more mayors, more people come on board,'' Pawlenty said after touring CanadaDrugs.com, a Winnipeg business where operators fill up to 1,700 prescriptions a day, most of them destined for the United States.

Pawlenty gave the growing cyber-drug industry a big thumbs-up after his tour to review safety standards at online pharmacies in Manitoba, home to one-third of Canada's 150 Internet operations.

"I came away reassured and excited,'' he said.

Last month, he announced plans to help people in his state buy cheaper drugs from Canada via the Internet. Those plans include negotiating drug prices and setting up a Web site linking Minnesotans to Canadian pharmacies that meet state standards.

"We were told that the Canadian system meets or exceeds the FDA's (U.S. Food and Drug Administration's) requirements and expectations for safety,'' he said.

"We also learned that there are a number of Canadian federal and provincial and industry protocols and accreditations ... and as you look at that it appears to be meeting or exceeding the safety stands in the United States.''

The FDA opposes the importation of drugs from Canada and other countries. It says some drugs don't meet U.S. specifications on refrigeration and labeling.

Also opposed are big pharmaceutical companies, who say the lost revenue from American sales will stifle their research into new drug treatments. Four drug companies, including Pfizer and GlaxoSmithKline, have begun limiting supply to Canada to curb exporting, and have threatened to go further.

"In my own view, the actions and threats of the pharmaceutical industry in this regard are reprehensible,'' Pawlenty said.

"They're just threatening flat out in the United States that they might retaliate against Canadian pharmacies by withholding supply. If it were to become the case, I would hope and I would strongly encourage legal action against the pharmaceutical industry to prohibit that,'' he said.

Manitoba Premier Gary Doer said he doesn't believe any kind of artificial barriers should be put up.

"We don't have a Berlin Wall across the Minnesota-Manitoba border,'' he said after meeting with Pawlenty.

"If we do believe in fair trade, we should continue the practice of trade, and pharmaceuticals should be part of that trade,'' he said.

Manitoba raises an estimated $150 million a year in taxes from Internet sales.

Several Democratic and Republican governors and a majority of members in the U.S. House of Representatives support importing drugs as a way to keep costs down.

Illinois Gov. Rod Blagojevich sent a delegation to Manitoba last month to examine the Internet pharmacy trade, and commissioned a report that said the state could save about $91 million a year by buying drugs from Canada for its employees and retirees.

Some studies have estimated prescription drugs in Canada are as much as 60 percent less expensive than in the United States for several reasons, including federal government regulation.

Opposition to a cross-border pharmacy industry has been brewing on this side of the border as well, however. Some Canadian pharmacists believe it will lead to higher prices and a shortage of drugs in the country.

Federal Health Minister Anne McLellan has said she wants to know whether the booming export industry is leaving pharmacists in Canada short of drugs.

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By DAVE KOLPACK, Associated Press Writer

WINNIPEG, Manitoba -- Large Canadian and American flags hang from the main call center at CanadaDrugs.com, where operators fill between 1,300 and 1,700 prescriptions a day, almost all for customers in the United States.

Business is booming at most mail order and Internet pharmacies in Canada, despite warnings by pharmaceutical companies and the U.S. Food and Drug Administration about the safety of imported drugs.

"We're not hidden in a back room, we're not smacking mosquitos and we're not counting polar bears," said CanadaDrugs.com spokesman Bob Fraser, giving a tour of the 24,000-square feet facility. "We have nothing to hide. We welcome all inspections."

Fraser and his company were preparing this week for a visit today from North Dakota and Minnesota government officials, including North Dakota Lt. Gov. Jack Dalrymple and Minnesota Gov. Tim Pawlenty.

Pawlenty has said he wants to set up a Web site that would list approved Canadian distributors of prescription drugs. Eventually, he hopes to expand his plan with incentives for state employees who use the site.

One purpose of the trip, which includes meetings with Canadian officials, drug wholesalers and pharmacists, is to talk about safety.

Safety standards for mail order and Internet pharmacies in Canada already exceed those in the United States, said David MacKay, executive director of the Canadian International Pharmacy Association.

"This whole premise that our system is not as safe, or it could introduce counterfeits, is a bogus premise," said MacKay, who will host the Americans. "The pharmacies are bona fide licensed pharmacies, fully inspected by the provinces they do business in."

"A lot of the governors know they can seize upon this as a political agenda and are genuinely interested in helping their citizens," MacKay said. "They know that a lot of their citizens are already ordering from Canada, so why not set up a system that helps them as a resource to make an educated decision to purchase safely?"

The North Dakota and Minnesota officials plan to tour CanadaDrugs.com, which MacKay said is the benchmark in the industry. It's one of 18 member pharmacies in CIPA, he said.

Any U.S. prescription is checked by five professionals before it reaches the patient, Fraser said. That includes three pharmacists at the plant, one Canadian doctor and the U.S. doctor who writes the prescription.

"On a daily basis we catch drug allergies, potential interactions, duplication on therapy and inappropriate therapy," Fraser said.

All drugs are inspected, approved and registered by Health Practices and Food Branch, Canada's version of the United States' Food and Drug Administration, Fraser said. All packages are sealed with the original manufacturer's label, he said.

CanadaDrugs.com does 87 percent of its business over the phone and 13 percent on the Internet, which is typical for most companies, MacKay said.

"We require prescriptions, we require a patient medical history, and we require a patient agreement which put the onus on us to continue the care between the patients and us."

There have been no cases of counterfeit drugs in Canada, MacKay said. Compared to the United States, it's easier to monitor drug wholesalers in Canada because they are federally regulated and there are fewer of them, he said.

"The less stops along the way, the less opportunities to introduce counterfeit medications," MacKay said.

Calls to the Pharmaceutical Research and Manufacturers of America were not immediately returned.

The drug supply is safer in Canada than in the United States, said Peter Wycoff, spokesman for the Minnesota Senior Federation,

"This whole idea that the FDA can't guarantee the safety of drugs from other countries may be true, but it can't prove the safety of drugs in this country, either," Wycoff said. "The FDA is only now getting around to suggesting that factory-sealed containers might be a good idea in this country."

Wycoff's group has an agreement with CanadaRx of Toronto under which any member can get drugs mailed from Canada at about half the U.S. retail price. Many of the members are not familiar with the Internet and want help with paperwork, he said.

"A person can go to any one of 30 to 40 legitimate pharmacy systems and do the same thing," Wycoff said. "The big issue is to be doubly sure that any pharmacy you're dealing with is licensed by the province."

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State Continues Canadian Drug Benefit

By Bruce Edwards

RUTLAND HERALD - A South Burlington company that helps Vermonters purchase lower-priced Canadian prescription drugs has withstood a challenge from the Vermont Board of Pharmacy.

The Vermont Board of Pharmacy filed a complaint earlier this year with the secretary of state’s Office of Professional Regulation alleging that Discount Prescription Services (formerly American Drug Club) should be shut down because it was not a licensed pharmacy, according to Thomas Anderson, president of Discount Prescription Services.

An ensuing investigation found no basis for the complaint of unprofessional conduct, which was dismissed in September.

“We’re not a pharmacy, and we don’t stock any drugs or sell any drugs,” Anderson said.

Rather than being in the business of selling prescription drugs, Anderson said his company helps Vermonters obtain their medications from a licensed Canadian pharmacy, helping clients fill out the required paperwork, which is then mailed or faxed to Canada. Clients then receive their medications in the mail, usually within two weeks

The Vermont Board of Pharmacy complaint stemmed from concerns about the safety of imported prescription drugs. Board member John Dorvee said that “the complaint was dismissed because we don’t have jurisdiction over someone who has a storefront operation.” Dorvee indicated, however, that one option to halt the importation of drugs from Canada into Vermont would be to take action directly against Canadian pharmacies because those pharmacies are not licensed to sell drugs in Vermont.

Anderson, who also sells life and group health insurance, started Discount Prescription Services earlier this year to help Vermonters purchase Canadian drugs, which cost 30 to 80 percent less than the same drugs sold in the U.S.

Today, Anderson said, Discount Prescription Drugs has several hundred customers, mostly senior citizens on fixed incomes, who have a hard time paying for their U.S.-bought medications. He said approximately 80 percent of the business is repeat orders.

Like the Vermont Board of Pharmacy, the federal Food and Drug Administration has balked at endorsing the reimportation of Canadian drugs. But Anderson argues that safety is not an issue.

“There certainly haven’t been any problems at all,” he said. “As long as we deal with Canada, they operate exactly as we do.”

While heartened by the ruling by the secretary of state’s office, Anderson said the real answer lies in lowering prescription drug prices in this country.

There is growing sentiment in Congress to legalize the reimportation of prescription drugs from Canada. Late last month, a contingent of state and local officials from Vermont attended a meeting in Boston on the issue.

Anderson said he has received support from Rep. Bernard Sanders, I-Vt., and Sen. Patrick Leahy, D-Vt. He said he has met with Burlington officials as that city contemplates assisting its employees to purchase cheaper drugs north of the border. He said he also receives referrals from the Chittenden County Area Agency on Aging.

Anderson said he is still considering opening a branch office in Rutland. The company also has a Web site at www.burlingtondrugclub.com, where someone can fill out the necessary forms to obtain prescriptions from Canada.

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By Randall Palmer

OTTAWA, Oct 29 (Reuters) - The Canadian government has challenged the United States to block the flow of cheap prescription drugs from Canada if it thinks it is a problem, a senior health official said on Thursday.

The challenge was made in discussions with the U.S. Food and Drug Administration as controversy swirls over the idea of U.S. seniors, cities and states filling their prescription needs in Canada.

"We have reminded the United States that they have responsibilities and they have authorities within their own country to stop the importation of products within their own country, and have reminded them of their responsibilities in that regard," the official told a media conference call.

It is technically illegal under U.S. law to import drugs from foreign pharmacies. And while the FDA says imported drugs are risky and it would like the practice to stop, it has not yet moved to stop the flow.

Meanwhile, Canada has reinforced to the FDA that its drugs are safe and has asked it to provide evidence of any products coming in through Canada that do not meet Canadian regulations.

"To date, we have not received that evidence," the official said.

Canada's Assistant Deputy Minister of Health, Diane Gorman, was traveling to Washington on Thursday for a previously scheduled meeting with FDA Commissioner Mark McClellan.

The whole issue of Internet pharmacies, which are used to sell to the United States, was not on the agenda but was certain to come up during their talk, the Canadian official who briefed reporters said.

The Canadian government broke its public silence on the issue this week by calling on pharmacy and medical associations to condemn the Internet pharmacy practice and spoke of the risk that it could cause shortages in Canada -- though it said it had no evidence of this yet.

New York City Mayor Michael Bloomberg said on Thursday that New York State could save $643 million a year by buying drugs from Canada for Medicaid patients.

He was the latest in a string of mayors and state governors who have started looking north for cheaper drugs.

CHICAGO (Reuters) - Importing cheaper prescription drugs from Canada could save Illinois up to $90 million a year without compromising safety, says a state report released on Sunday.

Investigators found that drugs from Canada are safe and effective, that Canadian regulators provide protections that are about the same as those in the United States, and that drugs sold in Canadian pharmacies are made in facilities approved by Health Canada, the federal health agency.

"Both countries' methods of ensuring safety and efficacy of prescription drugs are comparable," says a summary of the report released by Illinois Gov. Rod Blagojevich and U.S. Rep. Rahm Emanuel, an Illinois Democrat.

Blagojevich ordered the study in September to determine whether medicines from Canadian sources could provide a safe alternative and help the state and its employees and retirees save money.

Other states including Iowa, Minnesota, Wisconsin are looking at buying prescription drugs from Canada for state workers or for state-run Medicaid health programs.

Last week New York Mayor Michael Bloomberg called the concept "a great idea. ... It is on our to-do list."

A growing number of U.S. residents are already ordering prescription drugs over the Internet or buying them outside the United States, where regulatory differences makes them substantially cheaper.

U.S. states, struggling with record budget shortfalls and increasing numbers of uninsured, are challenging warnings from the U.S. Food and Drug Administration that the safety of imported drugs cannot be guaranteed.

Congress is debating adding a prescription drug benefit to the Medicare health insurance program. The pharmaceutical industry is fighting one version that would make it substantially easier to import drugs from outside the United States.

Importing prescription drugs is technically illegal except by manufacturers. There is a gray area, however, under which drugs can be imported for personal use.

The Illinois report said there is an additional guarantee of safety because 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 the United States, it said.

The report said if all eligible Illinois prescriptions were filled through Canada, state employees and retirees using three prescriptions a month would save up to $1,008 per year, and overall savings for the state and employees combined would be as high as $90.7 million annually.  

Copyright © Reuters 2003

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By Ceci Connolly

WASHINGTON POST - Iowa Gov. Tom Vilsack said he intends to seek lower-priced medicines from Canada for state employees, a move that puts added pressure on Congress and the Food and Drug Administration to find a way to control the soaring cost of prescription drugs in this country.

Vilsack, a Democrat, became the second governor in 10 days to join a growing contingent of advocacy groups, for-profit businesses and one city in looking across the border for cheaper drugs.

"People do not understand how they can purchase something in Canada for far less than it costs here in the United States," Vilsack said in an interview.

Vilsack and Illinois Gov. Rod Blagojevich (D) have asked aides to draft plans for state health insurance programs to buy medicines from Canadian suppliers.

If the savings are significant, Vilsack said, "we should take every step possible to . . . take advantage of these Canadian opportunities."

This year, Iowa is spending $ 54 million on drugs for 70,000 employees, retirees and their families, up from $ 44.5 million in 2001, officials said. Vilsack said he is dispatching his top health care adviser to Vancouver to meet with Canadian officials on ways to open the border for legal drug importation.

As many as 2 million Americans now purchase prescription drugs illegally outside the United States, according to government and private estimates, but the FDA has done little to stop individuals and nonprofit groups from buying drugs in Canada and Europe, where the savings range from 30 percent to 75 percent.

William Hubbard, senior associate commissioner at the FDA, repeated the agency's standard warning that it cannot guarantee the safety of medicines coming from other countries. FDA inspectors and undercover investigators have found numerous instances in which medications alleged to have come from legitimate Canadian pharmacies were counterfeit, mislabeled or expired, he said.

Such warnings have had little effect, however.

"They can't stop this momentum," said Springfield, Mass., Mayor Michael J. Albano. "They can't stop this movement." The city has registered 1,100 city workers and retirees for a newly launched prescription drug plan based in Canada, and Albano has rebuffed FDA urgings that he desist.

Elsewhere, however, the FDA is pursuing a court injunction to halt Canadian drug sales by Oklahoma-based Rx Depot and has sent stern warning letters to another importer, CanaRx, and the state of California, which also expressed interest in Canadian imports.

With limited resources, the FDA has put profit-making importers at the top of its priority list for enforcement, Hubbard said.

"You can't be selective in your enforcement," said Rep. Rahm Emanuel (D-Ill.), who is co-sponsoring legislation to open Canadian and European markets. "It's either a public health risk or it's not."

Other experts contend drug importation regulations are vague and ripe for a court challenge. "The law authorizes the FDA to prevent unsafe drugs from coming into America," said Kip Sullivan, a universal health care advocate in Minnesota who has organized drug-buying trips to Canada. "That's different from saying the FDA has the authority to stop all foreign drugs."

Others argue the FDA is not fulfilling its obligations.

"What proof is there that there is a significant risk?" Vilsack asked. "And if there is a risk, let's do something about it."

In recent weeks, both sides have ratcheted up their efforts. In Congress, a bipartisan coalition is threatening to oppose broad Medicare prescription drug legislation if it does not include provisions allowing consumers to shop for better prices in Canada.

Recently, 142 House Democrats sent a letter to the members of a Medicare conference committee suggesting they were "unlikely to support a Medicare drug benefit that does not include" language making it legal to purchase FDA-approved drugs from Canada. In July, 243 House members, including 87 Republicans, voted for the legislation.

Senate Finance Committee Chairman Charles E. Grassley (R-Iowa) has said he supports that approach, but his House counterpart, Ways and Means Committee Chairman Bill Thomas (R-Calif.), does not.

Several lawmakers said the drug importation issue, often called "reimportation" because many Canadian medications are made in the United States, has become politically potent because it marries economic concerns with fair trade issues and general principles of equity.

Said Rep. Richard E. Neal (D-Mass.), "You are hearing it at home, no matter where you travel."

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Blagojevich unveils on-line petition drive pressing FDA to reverse its policy on importing prescription drugs from Canada
Governor asks consumers to help put pressure on federal government to open access to lower priced medicines

Launches new website:  www.affordabledrugs.il.gov

CHICAGO (OFFICE OF THE GOVERNOR) – Gov. Rod R. Blagojevich today announced he is enlisting the help of American drug consumers in his effort to convince the U.S. Food and Drug Administration to change its policy prohibiting states and local governments from buying FDA-approved medications for a lower price from Canada.  The Governor is asking consumers to fill-out an on-line petition in support of drug importation at www.affordabledrugs.il.gov.

“The FDA can ignore our letters.  They can ignore our calls.  But they can’t ignore the people forever.  And so today, I’m launching an electronic petition drive so that the people can be heard on this issue,” said Blagojevich. 

“If you think that you should be able to reduce your prescription drug costs – let the FDA know. Let the FDA know they can’t keep hiding behind the excuse of safety. Let the FDA know you want your prescription drug costs reduced.  Log on to our website at www.affordabledrugs.il.gov  – sign our electronic petition – and let your voice be heard.”

The on-line petition is part of a new website launched by the state today with information about the discrepancy between American and Canadian drug prices, the impact of high prices on consumers – especially the elderly, activity in Congress on the issue and recent editorials from

around the nation in support of drug importation efforts.  The site contains a price comparison chart where viewers can assess their potential savings if they were able to buy their prescription medications at Canadian rates.

In addition to the on-line effort, the Governor said petitions will be available in hard-copy at senior citizen facilities throughout the state, or can be requested over the phone by calling toll-free (866) 296-6322.

In September, the Governor asked the state’s two Special Advocates on prescription drugs to study and report to him on the cost-savings and feasibility of reimbursing state employees and retirees – and potentially enrollees in the state’s new senior citizen discount buying club – for drugs they purchase in Canada, where prices are significantly lower.  Illinois currently spends $1.8 billion a year on prescription drugs for all its health care programs combined, $340 million of that is just for state employees and retirees.

Last week the Special Advocates led a delegation of the administration’s top policy, medical and legal experts on a fact-finding trip to Canada.  The group met with executives from CanaRx, the company that administers the drug import program for the city of Springfield, MA, as well as pharmacists and executives from retail and online pharmacies and representatives from the Canadian government.  The delegation will use the information it gathered in the report it is preparing for Blagojevich on the benefits and challenges of importing drugs.

While he awaits the results of the Special Advocates’ study, Gov. Blagojevich has been lobbying the FDA and Congress to change current rules that prohibit state and local governments, pharmacies and consumers from buying prescription drugs from Canada.  Blagojevich pointed out the contradictory messages the FDA sends out on the safety of Canadian drugs, claiming imported medications do not meet up to U.S. standards and therefore will not be allowed to enter the American market, while at the same time looking away as more than a million individuals in the U.S. cross the border or send away to purchase their prescription drugs for significantly less from Canada.

“The FDA, to date, has refused to permit state and local governments to import prescription drugs from Canada.  They say we can’t do this because it may not be safe.  While they use that reason time after time, the FDA has yet to explain why they permit private health plans to reimburse their members for purchasing prescription drugs from Canada,” the Governor commented. 

“Either it’s safe or it’s not safe. If it’s safe, let the people benefit.  If it’s safe, stop doing the dirty work for the drug manufacturers, and start giving people the chance to save some money.  If it’s not completely safe just yet, instead of just throwing up your hands and refusing to deal with the issue, let’s work on finding ways to make it safe,” Blagojevich urged.

Blagojevich will deliver the petitions gathered from the website and partners around the state to the FDA to demonstrate the wide support for allowing states to find new solutions to the worsening crisis from high drug prices.

“If we make our voice heard – if we tell the FDA that we’re not going to just let them ignore the needs of tens of millions of Americans – if we demand that they stop protecting the interests of the big drug companies, then maybe they’ll start working for the interests they’re supposed to serve: the people,” the Governor added.

The Special Advocates’ report will be submitted before the end of October.

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Senate Votes to Allow Drug Reimportation From Canada

Associated Press

WASHINGTON (AP) — The Senate voted Friday to allow U.S. pharmacists to buy prescription drugs in Canada, where the same medicines sell for less, and resell them here, another attempt to drive down the rising cost of drugs.

The 62-28 vote attached the measure to the pending Medicare prescription drug bill moving through Congress, where approval in the House and Senate was expected by the end of next week.

Lawmakers, especially those living in states bordering Canada, have been pressing for the change for years, spurred in particular by senior citizens in their states who board buses to cross the border and buy cheaper drugs.

But the provision includes a measure that could prevent it from ever becoming law: It requires the secretary of health and human services to certify that the reimportation can be done safely. A similar law is already on the books, but former HHS Secretary Donna Shalala would not certify that it could be done without risk to patients. Her successor, Tommy Thompson, said the same.

That didn't stop the Senate from acting. Sen. Byron Dorgan, D-N.D., successfully argued that Canada's safety controls were just as reliable as those in the United States and U.S. consumers have nothing to fear from drugs bought from Canadian pharmacists.

He added that this bill is different because it allows reimportation only from Canada, where the drug safety system is nearly identical to the U.S. system. Prices are lower, however, because the government controls them by law.

"If you believe it's unfair that we pay the highest prices in the world for prescription drugs, then vote for my amendment," Dorgan said.

Opponents argued that it poses a particular danger in today's age of bioterror threats.

"It opens a new door, a new opportunity, and it is a new threat to the security of the people of this country," said Sen. Thad Cochran, R-Miss.

The vote followed approval a day earlier of another strategy to drive down prices, overwhelmingly endorsing a plan to bring generic medicines to the market more quickly, 94-1.

"This is a very good day for consumers," Sen. Charles Schumer, D-N.Y., said after the generic drug provision was added Thursday.

The generic drug provision essentially codifies regulations issued by the Food and Drug Administration last week to make it more difficult for brand-name companies to block generic competition.

The provision also is designed to penalize generic drug companies if they enter deals in which brand-name competitors pay them to delay bringing the lower-cost alternative to market.

Off the Senate floor, a block of conservatives was lobbying to boost support for private companies, and it appeared that lawmakers had brokered a compromise to satisfy them. Conservatives see private insurance as the future of Medicare in delivering both drugs and routine health care.

Fearful that seniors would stay away from new managed care options being created by the bill, they want to pay private companies more, hoping the benefits would be good enough to attract a significant number of the elderly.

In the House, the second of two committees approved its version of a Medicare bill Thursday, defeating a series of Democratic amendments aimed at sweetening the benefits and reshaping the program. Approval by the House Energy and Commerce Committee, on a near party-line 29-20 vote, sent the bill to the House floor for debate next week.

The $400 billion, 10-year Medicare plan would, for the first time, give all seniors federal subsidies to buy prescription drugs, relying principally on private companies to deliver the benefit. It also would create a new Medicare managed care option — preferred provider organizations — which supporters hope would give seniors more choice while saving the government money.

At issue, though, is how much money the government will have to pay PPOs to attract seniors. The Congressional Budget Office estimated that, as written, the bill would attract just 2% of seniors into PPOs, though other estimates put it higher.

At a stormy closed-door meeting Thursday, Republicans led by Sen. Jon Kyl of Arizona demanded more money for PPOs. They want payments to be based on competitive bidding by the insurance companies, not on the normal price of caring for a Medicare enrollee.

Senate Majority Leader Bill Frist, R-Tenn., said he was well aware of the tension and was trying to walk a careful line. "I'm going to do my best not to let it be an extreme bill to the left or to the right," he said.

Frist had $12 billion not yet allocated to help solve this problem and one other: how to keep employers from dropping coverage for their retirees once the Medicare benefit kicks in.

The controversy set off a series of daylong meetings involving key lawmakers and Thompson, officials said. At day's end, Frist said he hoped for a compromise that would give Kyl and conservatives their way, but only after a delay of four or five years. And he said Friday that compromise was still on track.

Copyright 2003 The Associated Press

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