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Local outlets sell drugs from Canada
Two storefront outlets that sell low-priced prescription drugs from Canada have popped up in recent weeks in the Louisville area — reflecting a national trend that has generated controversy.
The U.S. Food and Drug Administration has threatened a crackdown on such outlets, saying they in essence are unlicensed pharmacies.
But operators say they're acting legally and dare the government to stop a practice that offers seniors much lower drug prices — typically about half of U.S. prices , on average .
The FDA wants "to shut down people like me," said Steve Yount, who opened Discount Medicine of Canada in a New Albany , Ind., shopping center a few weeks ago. "I'm willing to take that chance. . . .
"Do you want to be the politician that comes in and shuts me down? So I can tell all the elderly people now, `I'm sorry, you won't be able to get your medications at 60, 70, 80 percent off.' "
Yount's storefront was the second to open in Southern Indiana recently. Discount Drugs of Canada opened in Clarks ville several weeks ago.
The businesses accept customers' prescriptions and send them to pharmacy outlets in Canada that mail orders to U.S. homes. The main market is seniors, because Medicare doesn't cover prescriptions.
Pharmacy officials said they don't know of any that have opened in Kentucky, at least not yet. If one does, "we will proceed fairly quickly with an injunction" to close it, said Michael Mon é , executive director of the Kentucky Board of Pharmacy. He said the businesses aren't pharmacies, and "only pharmacies can accept prescriptions."
Indiana officials said they have an eye on the practice but aren't sure it breaks state law.
The FDA says it is sure that importing mail-order drugs is illegal — but the law is almost impossible to enforce, since an estimated 2 million drug packages enter the U.S. each year.
Regardless of its legality, the practice has been embraced by many seniors.
Drug prices "are about to break me, and I'm trying to seek help," said Rose Litch of New Albany as she visited Discount Drugs of Canada's storefront on Ind. 131 last week.
She had come with a prescription for a generic version of an acid-blocking drug for her husband. The company's price for a three-month supply was $174 — about half what she would have paid at a drugstore.
Litch said she was elated with the savings and would be back to order more drugs. She said she and her husband spend about $500 a month on prescription drugs, which is eating up "our little nest egg."
Buying drugs from Canada has grown in recent years as prescription drug prices have skyrocketed in the U nited States . An estimated 1 million Americans are expected to buy more than $1 billion in drugs from Canada this year.
The Canadian government controls drug prices by negotiating lower rates with drug makers through its national health-care system.
Plus, the American dollar buys more than the Canadian dollar, boosting the savings for U.S. buyers.
Brand-name prescription drugs from Canada on average cost about 49 percent less than those bought from U.S. online pharmacies, according to pharmacychecker.com, a Web site that evaluates online drug prices.
Stores draw seniors
The price disparity has led to organized trips to take seniors in northern border states to Canada to buy drugs. It has also led to thriving Internet sales from Canadian pharmaceutical outlets.
But many seniors aren't comfortable with making purchases on the Internet. So storefronts began popping up in the past year to allow face-to-face buying.
They are generally owned by Americans and affiliated with a pharmacy outlet in Canada. Operators receive a percentage commiss ion on sales.
The store fronts don't receive or label drugs and say that keeps them from running afoul of being charged with running a pharmacy without a license.
But the FDA and some states' health officials think differently.
The FDA says it is illegal to import drugs that have not received FDA approval. And even importing back to the U.S. a drug that was made here and shipped to another country violates the Federal Food, Drug and Cosmetic Act, the agency says.
The agency hasn't tried to stop individuals from going to Canada and bringing back a personal supply of medicines, and it hasn't been able to police the widespread mailing of drugs from Canada to U.S. customers.
But the storefronts that have opened in recent months in Florida and other states are a standing target, and the FDA and some states have moved against them.
In March, the FDA sent a letter to an Arkansas storefront, Rx Depot, saying that it must stop helping customers buy drugs from Canada or risk legal action. The Arkansas pharmacy board issued a similar warning , but the outlet is still open.
Other states have also said they are investigating storefronts, though no prosecutions have resulted.
Concern about safety
"We're really concerned about safety here," said FDA Associate Commissioner William Hubbard. "We have seen examples of people who've ordered these drugs from overseas and they get all kinds of unlabeled and potentially counterfeit things. . ..
"You have a virtually 100 percent chance when you go to a local pharmacy in the United States of getting a safe and effective drug. But when you go to one of these storefronts, or one of these Internet sites, you don't have any protection."
However, Hubbard acknowledged there is no known case of a person being harmed by a drug sent from Canada.
Canadian pharmaceutical outlets and their supporters say that buying drugs from there is safer than from many other countries. That's because Canada has its own FDA-like agency and requires prescriptions to be screened by a Canadian doctor before they're mailed out.
The issue has pitted the FDA against some members of Congress who want to make drug sales from Canada expressly legal. The y include U.S. Rep. Dan Burton, R-Ind.
"Americans should not be paying exorbitant prices for pharmaceuticals when right next door the very same product is being sold for (one half or less) of what it is in the United States," said Burton, of Indianapolis.
Drug makers are "making a killing" on U.S. sales, while "we've got a lot of seniors around the country who have to decide between food and (drugs)," he said. "I don't like to see the government interfere in the private sector. But when Americans are getting ripped off by companies of any type, then I think they deserve fair treatment."
Burton is chairman of a House subcommittee that has held hearings on the subject and plans to hold more. Witnesses have included Hubbard.
Burton said he also wants U.S. drug makers to testify. One, GlaxoSmithKline, has said it will cut off drug supplies to Canadian companies that sell drugs to U.S. consumers — a stance that would become illegal under a pending bill Burton co-sponsored.
Congress actually passed a law in 2000 that would have allowed prescription drugs manufactured in the United States and exported to Canada and some other countries to be reimported for sale here. But it hasn't been implemented.
The measure required the Health and Human Services secretary to first determine that adequate safety could be maintained. Secretary Tommy G. Thompson and his predecessor, Donna Shalala, concluded that couldn't be guaranteed, so the bill never took effect.
Pharmacist groups in Kentucky and Indiana also are against buying from Canada, and not just to maintain customers, they say.
"If you don't have a local pharmacist looking at the drugs you take, you don't know what kind of interaction you're going to have between these drugs. And certainly a Canadian pharmacist is not going to drive down here to help you," said Mike Mayes, executive director of the Kentucky Pharmacists Association.
"We obviously think people should be buying their drugs in the United States, because there's no guarantee where those drugs come from when they come out of Canada," said Lawrence J. Sage, executive vice president of the Indiana Pharmacists Alliance.
"We've tried to construct a safety net . . . in the United States" for drug distribution, and people who buy elsewhere are "shooting craps with (their) life," he said.
The Indiana State Board of Pharmacy is aware of the Southern Indiana storefronts but hasn't determined if they're breaking state law, said Lisa Hayes, executive director of the Indiana Health Professions Bureau.
The board regulates pharmacies, which the storefronts are not. But Hayes noted that Indiana's pharmacy code makes it illegal for a non-pharmacy business to have words like "drugs" or "medicine" in its title if it's done to mislead customers.
Crackdown expected
The operators of the Southern Indiana storefronts said they realize they might not be able to stay in business long. They say either the pharmaceutical industry will use its influence to accelerate a crackdown, or the United States will take action to lower drug prices so Canadian prices aren't so alluring.
Meanwhile, they say business is picking up as word gets around. "We're giving a tremendous amount of quotes," said Yount, whose Discount Medicine of Canada is on Grant Line Road.
Jon Hallis, part-owner of Discount Drugs of Canada, said the business has 100 customers or more.
Customers of the businesses wonder why U.S. drug manufacturers charge so much more here than in other countries.
Jeff Trewhitt, spokesman for the Pharmaceutical Research and Manufacturers of America, said manufacturers need profits from America's "competitive marketplace" to fund research into new drugs.
He said the average cost of developing a new drug is about $800 million, and only one in five drugs tested on human patients is approved for marketing.
Canada's price controls leave too slender a profit to leave money for research and development, he said. If the United States had such controls, he said, "we would not have as much innovation" in creating drugs.
Seniors who pay for drugs out of pocket are more worried about prices than policy.
"Certainly these drug companies . . . aren't selling them (in Canada) and losing money," said Frank Kavich of Louisville.
He said he and his wife , Geraldine Kavich , saved "close to half" on her pain medication by buying through Discount Medicine. He said he inspected the packaging carefully and it seemed to be the same brand-name product they were used to getting.
Laura Everbach of New Albany had even larger savings through Discount Drugs on an eye medication she had been buying at Walgreens.
"I got three tubes, I think, for what I would have gotten one," she said.
Even after paying the company's $13 shipping fee, "it's a big savings," she said. Shipping is a flat fee no matter how many prescriptions are ordered.
"I know (the FDA says) it's dangerous, because they don't want you to buy them there (Canada). They want you to get them here," she said. "But I don't know how they think poor people — you know, on Social Security and fixed incomes — can do it. . ..
"If they ever make it illegal, I won't do it. But as long as I can get it that much cheaper.
More Prescription Drug News
Coleman calls for bipartisan answers on prescription drugs for seniors
Sen. Norm Coleman is optimistic Congress will pass prescription drug legislation this year, possibly by July. And that was good news to some area seniors who have been working to get drug price relief for years.
Coleman is also convinced that recently passed federal tax cuts will create jobs and get the economy going.
In Duluth Monday, Coleman emphasized it will take a bipartisan effort to get a drug measure through the Senate.
“We will not solve the problem of prescription drugs if it is just a partisan solution,” Coleman said. “We have to work across the aisle.”
Coleman said the nation faces challenges on the issues of health care, prescription drugs and Medicare.
“We need to come up with a program — something that gives seniors access to the benefits — that’s affordable,” Coleman said. “We need to have a health care system that gives seniors choices.”
“I’m a federal employee. Every American should have the same benefits I have,” he said. “I’ve got choices about health care plans, and we should be able to provide that to everybody, quality health care choices.”
He pointed out that Minnesota suffers from Medicare reimbursement disparity compared to states like Florida and New York, which are reimbursed at a higher level. There are also disparities in the state from urban to rural areas, issues he wants resolved.
Coleman believes these health concerns will be addressed under the Senate Majority Leader, Dr. Bill Frist.
While several in the audience of about 60 seniors questioned the wisdom of the tax cuts, Coleman said he was proud to be the deciding vote on that bill.
“One of the greatest challenges we face in America is getting the economy going,” Coleman said. “I believe that if you cut taxes you grow jobs.”
The senator would not debate the tax bill and got back to discussing the proposed Medicare drug benefit. It is expected to provide a discount drug option for all seniors with additional aid for low-income elderly.
Coleman said he also favors patent reform to get more lower priced generic drugs to market.
“We’ve got to have a better system in this country than going to Canada,” he said.
Carmen Arnold, with the Minnesota Senior Federation-Northeast, was skeptical but encouraged. “I hope this year, with the Republicans in charge, we get something done,” she said. “Even if it’s something little.”
The federation has taken the local lead on prescription price relief, lobbying politicians at all levels. It is also involved with a Canadian prescription drug import program.
The prescription drug price issue was expected to get even more debate in Duluth this week. Sen. Mark Dayton scheduled a panel discussion on problem Friday afternoon.
Residents seek Rx price relief
"Store-front pharmacies" help people get cheaper medicines by helping patients order them from Canada.
By Rachel Harris staff writer
May 31, 2003
When his pharmacy bill topped $400 a month, Gerald Kuhns didn't see what choice he had. That was half of what he and his wife, June, received monthly from Social Security -- and too much, the Stuart retiree reasoned, to be spending on prescription drugs.
So he and June grabbed three of their six prescriptions, piled into his Ford pickup truck and drove 16 miles to the Discount Prescription Center in Port St. Lucie.
There they learned they could buy the same prescriptions for about $70 a month -- a discount of 40 percent.
The catch? Since the drugs were coming from Canada, they could take up to three weeks to arrive. But for the Kuhnses, the savings were worth the wait -- even if it might mean breaking the law.
The Food and Drug Administra-tion calls them "store-front pharmacies," but owners of the businesses -- including two on the Treasure Coast -- point out they have no drugs or money on the premises.
"We're just a referral service, really," says Steven Betts, co-owner of the United States Discount Prescriptions of Canada in Port St. Lucie. "The medications don't come to us ... and the transaction is handled through Canada."
The operation is simple: Clients come into the office with doctor-written prescriptions and fill out a brief medical history. Both are faxed then to Canada, where a physician reviews them and signs off for a Canadian pharmacy to fill the prescription. The drugs are delivered directly to the client's home.
Betts says he simply aids people in doing what they could already do from home: Navigate Web sites of Canadian pharmacies.
Arno Tremann, 86, of Vero Beach, has been purchasing drugs from Canada for more than a year and saves about $1 a pill on his prescription, Vioxx. "And I know several people who do it," he says.
Even with shipping and handling fees, Canadian prescriptions are significantly cheaper, sometimes as much as 80 percent lower than U.S. pharmacy prices.
That's because of government-enforced price controls, which the United States lacks.
"We're doing people a public service," says Fred Ganz, owner of the Discount Prescription Center. In his sparsely furnished office -- two desks and a fax machine -- he works on a crossword puzzle between calls. "The gratitude of the people coming in here is just amazing."
Fort Pierce resident Camille Ciesla, 56, used Ganz's service to save between 40 and 75 percent on her prescriptions. Sydelle Fischer, of North Hutchison Island, saved $90 a month on her prescription for Zoloft.
"You're not getting the income you did before you retired," explains Fischer, 79, "so you're looking to save wherever you can."
Ganz estimates that 80 percent of his clients are seniors on a fixed income. Betts, whose business opened about two months ago, says he has processed "a few hundred" prescriptions.
"A lot of people come in here real skeptical and they don't believe us when we tell them the price," he says. "They think it's too good to be true."
Cracking down
According to the FDA, it is.
"The law is very clear on this," says Bill Hubbard, associate commissioner on policy and planning at the FDA. "It requires all imported drugs to be approved by the FDA, and with these businesses, they are not."
Specifically, federal law forbids anyone but the manufacturer from importing a U.S. drug to the United States. The only exception is the "personal use policy," which allows individuals to import small amounts of drugs that are unavailable in the United States for chronic illnesses .
For years, enforcement was lax. Then in March, the FDA issued a warning letter to an Arkansas storefront operation, calling its services illegal and a risk to public health. The case is still under review, says Tom McGinnis, chief pharmacist at the FDA.
"This is a new issue," he says, explaining the sudden crackdown on drug imports. "A year ago these businesses weren't around."
But Ganz points the finger at U.S. pharmaceutical companies, who lobbied for stricter enforcement. "They want to scare people away (from storefront operations)," he says. "They don't want to lose money."
Canadian pharmacies estimate that 1 million U.S. residents buy drugs each year from Canada, accounting for about $1 billion in sales. In 2002, U.S. drug sales topped $192 billion.
Florida 'not investigating the matter'
State governments also are getting involved. Authorities or pharmacy boards in at least 13 states have taken steps to shut down storefront operations, said Carmen Catizone, executive director of the National Association of Boards of Pharmacy.
"We see it as a significant health risk to the citizens of Florida," says Michael Jackson, executive vice president of the Florida Pharmacy Association. "You have entities receiving prescriptions and sending these prescriptions up to Canadian sources (to be filled), and they're not licensed by the Florida Board of Pharmacy."
A spokeswoman for Florida State Attorney General Charlie Crist said Thursday that he is not investigating the matter, but Ganz maintains he has the only license he needs: a permit from St. Lucie County that deems his business a public service.
He balks at the argument that his business is unsafe: "Canada is practically the United States, for God's sake. Are we really to believe that a Canadian pharmacist doesn't know what he's doing?"
Many of his clients share Ganz's optimism.
"As long as there is a prescription there, I can't see why it's not legal," Ciesla says. "It's not like they're just doling out your prescription. Your doctor is filling it."
To Gerald Kuhns, 74, it's no different than buying a car imported from Japan.
"This is the United States," agrees his wife, June Kuhns, 75. "We should be able to buy whatever we want."
State can't 'shut these people down'
In Florida, only one storefront operation has been investigated, says Bill Parizek, a spokesman for the state pharmacy board. He has declined to discuss details of that or any potential investigations.
"This is an issue we're aware of," he says, "but at this time....all we can do is gather information and share that with local law enforcement. We have no statutory authority to shut these people down."
The FDA meanwhile is working with Health Canada, its equivalent north of the border, on finding a Canadian law that could halt the importation of prescription drugs to U.S. clients.
Although authorities have failed so far, some local business owners don't want to take the chance. The Bright Sky Business Center in Vero Beach, for instance, recently stopped advertising its prescription mail-order service.
"We haven't completely dropped the whole idea," says Vice President David Rodriguez, "but we've put it on the back burner."
Staff at the computer services business will still aid clients in navigating Canadian pharmacy Web sites, he says, but it's not a service they advertise.
Not to say he agrees with the FDA. "We're talking about American drug companies selling to Canadian pharmacies," he says. "(They're) the same drugs we're buying here. Pfizer is Pfizer. And people should be able to buy them anywhere they want."
Looking for alternatives
Hubbard says the FDA is reconsidering current drug importation laws and will likely issue a final ruling this year.
But at least two pharmaceutical companies aren't waiting for the FDA to halt storefront operations: In January GlaxoSmithKline announced it would stop supplying Canadian Internet pharmacies that serve U.S. customers, and in April, AstraZeneca decided to limit its supply of drugs to Canadian wholesalers and pharmacies.
In response, Rep. Bernard Sanders, an independent from Vermont, filed legislation that would fine drug companies up to $1 million for blocking Canadian pharmacies from selling their drugs to U.S. customers.
Specifically, the bill would amend the Federal Food, Drug, and Cosmetic Act, which limits re-importation of prescription drugs from Canada.
The bill is stalled in the House.
State legislators likewise have made little headway in providing access to cheaper drugs. A bipartisan plan that would have offered discounted prescriptions to 250,000 of the state's seniors passed this year in the House but failed to make it through the Senate.
Gerald Kuhns, for one, isn't surprised.
"Politicians won't do anything," he says. "Who do you think is lining their pockets?"
It's only a matter of time until the government shuts down outfits like the Discount Prescription Center, Kuhns says. Then he and his wife will have to dip once more into their dwindling savings to pay for costly prescriptions.
"If we live too long," he says, "we're in serious trouble."
Access to Canadian prescription drugs gets easier
May 11, 2003
By BRUCE EDWARDS Herald Staff
Rutland area senior citizens and others who have felt the pinch of high prescription drug prices will soon have a more affordable option.
American Drug Club, a prescription drug assistance service that sells low-cost Canadian drugs, has plans to open a branch office in Rutland within the next few months, according to company president Thomas Anderson.
Anderson, who opened his first office in South Burlington earlier this year, said his clients can save between 30 and 80 percent on their prescriptions because Canadian drugs are so much cheaper than the same drugs sold at pharmacies in the U.S.
American Drug Club assists customers to legally obtain their prescriptions from an affiliated Canadian pharmacy.
“We don’t sell drugs in any way. All we do is to help patients with their paperwork, and that paperwork is then mailed or faxed to Canada,” Anderson said.
Once the paperwork is completed, he said, clients receive their drugs in the mail — usually within two weeks.
He said customers can also fill out the necessary forms on the company’s Web site.
In return for that assistance, Anderson said he receives a small fee from the Canadian company. However, he said, the fee does not increase the price of medications to his customers.
As an example of the cost savings, American Drug Club says a 90-tablet (20mg) supply of the cancer drug Tamoxifen costs $37.33 through them, while that same drug costs $405 at a Burlington pharmacy. Celebrex, a popular arthritis drug, costs $63 for a 90-tablet (100 mg) supply through the club, but $147 at a local pharmacy.
Anderson, who sells life and group health insurance, said he decided to open the business as a way “to cut the costs of drugs down.”
American Drug Club is owned by a Canadian company, ADC Health Management Ltd. Each U.S. office is independently owned.
Anderson said American Drug Club intends to have 360 offices in the U.S. by the end of the year. In addition to South Burlington and Rutland, Anderson said he’s also considering opening offices in Montpelier and Brattleboro, and possibly Bennington.
American pharmaceutical companies have complained loudly about the importation of their less expensive drugs from Canada into the U.S.
The Vermont Pharmacists Association has also registered its opposition. James Marmar, the state association’s executive director, said the Food and Drug Administration has ruled that services like those offered by American Drug Club are “illegal.” Marmar cited a Jan. 11, 2002 letter from the FDA to the Manitoba Pharmaceutical Association that stated the agency regarded the importation of prescription drugs from Canada in violation of U.S. law.
Marmar added the FDA found that some drugs imported from Canada were counterfeit.
“Unfortunately, FDA doesn’t have the moral or political will to prevent these medications from coming across the border,” said Marmar, who also manages the Woodstock Pharmacy.
Anderson, however, pointed out that the drugs imported are U.S.-made drugs approved by Health Canada, the equivalent of the FDA in this country
And while Marmar said Vermont pharmacists are concerned about the welfare of their customers, he also acknowledged that the importation of less expensive drugs from Canada threatens pharmacies in the state where profit margins on prescription drugs are only 2 or 3 percent.
Despite its name, Anderson said American Drug Club has no annual or monthly dues.
And while senior citizens are the most likely customers because of the lack of a Medicare prescription drug plan in this country, Anderson said the service is available to any uninsured or underinsured individual.
Canada Rx may face state controls
Lower drug prices draw Colo. buyers
By Marsha Austin, Denver Post Business Writer
Within the next year, Coloradans could be buying prescription drugs from a state-approved list of Canadian pharmacies.
A handful of disparate interest groups Thursday urged Colorado regulators to begin overseeing Canadian pharmacies' sale of prescription drugs to Colorado residents. The trade is unregulated by the state because it violates federal law.
Consumer advocates, Colorado-based pharmacists and Canadian drug importers want the state to force Canadian pharmacies to abide by the same quality and safety standards as U.S. mail-order pharmacies doing business here.
During the recent legislative session, the Colorado attorney general's office suggested the state begin licensing Canadian pharmacies, but some state officials wanted more time to study the issue, said Rick O'Donnell, executive director of the Colorado Department of Regulatory Agencies.
O'Donnell's department is studying potential changes to Colorado law this summer and will publish its recommendations on the Canadian pharmaceutical trade in early October, he said.
In the meantime, websites and storefronts selling Canadian drugs are proliferating.
Trudy Pueppke opened a retail store called Rx of Canada in Boulder this month. She said business has been so good she's expanding to Denver on Sunday.
Pueppke, a Boulder resident, turned to Canada to fill her own prescription for migraine headaches. The discount was so deep - pills that cost $40 each in the U.S. she bought for less than $7 per pill in Canada - that Pueppke wanted to help others.
"I'm looking at grandmoms and granddads on fixed incomes and thinking, well, what do they do?" Pueppke said.
As more Coloradans buy from people such as Pueppke, the state's main concern is patient safety, O'Donnell said.
The Colorado Pharmacists Society has cautioned consumers against buying imported drugs because the Food and Drug Administration doesn't inspect the pharmaceuticals and can't guarantee such drugs are safe.
To date there have been no reports of a Colorado resident being harmed by Canadian drugs, said Matt Mayer, deputy director of the Colorado Department of Regulatory Agencies.
But state officials worry that by licensing Canadian pharmacies in Colorado, the state would be endorsing illegal behavior, Mayer said.
"You're asking us to put our head in the sand," he said.
The FDA prohibits businesses from reselling in the U.S. drugs manufactured here and exported to other countries. The agency also bars consumers from bringing drugs into the U.S. that are not FDA approved. The only exception is for those who have a dire illness that can only be treated by drugs not readily available in the U.S., said Ron Conley, an attorney for Arnold & Porter.
Consumers who buy a 90-day supply of prescription drugs from Canada, either through a website, a mail-order service or by traveling north of the border are technically violating federal law, Conley said.
But the FDA has not actively enforced such laws.
Canada's state-sponsored health care system imposes cost-controls on prescription drugs, and thus pharmacies can offer the drugs to consumers at anywhere from 20 percent to sometimes more than 50 percent less than U.S. pharmacies.
Consumer watchdogs favor licensing Canadian pharmacies to ensure patients who purchase drugs online or through the mail get quality medications and continued access to affordable prescriptions.
If the state cracks down on the purchase of Canadian drugs, low-income seniors in particular could turn to less reliable sources for affordable medications, said Laurie Kiusalaas, a spokeswoman for AARP Colorado.
"Seniors will go somewhere else if Canada dries up - like Mexico," Kiusalaas said.
Canadian drug importers are eager to gain legitimacy in Colorado and boost their business here. Representatives of several online pharmacies doing business in Colorado said Canada's pharmacy regulations are just as vigorous as the FDA's.
"There is no difference," said Lewis Jorgenson, president of sales and marketing for Calgary, Alberta-based CrossBorderPharmacy.com
CrossBorderPharmacy and other online drug importation services that buy drugs from licensed Canadian pharmacies say they would easily qualify for licensure in Colorado.
Colorado pharmacies that compete with Canada for business want to limit the amount of competition from north of the border.
Independent pharmacists from Colorado say they support state regulation of Canadian competitors because they fear for patients' safety under the current unregulated system.
Only one other other state, Arkansas, has stepped forward to officially regulate the cross-border sale of prescription drugs. But Colorado may do so if it's in consumers' best interest, O'Donnell said.
"If that's the case, we'll take an advocacy role," he said.
Arkansas recently passed a law requiring Canadian pharmacists to have a formal relationship with a state-based pharmacy to sell drugs, Mayer said.
Colorado to study possibility of licensing Canadian pharmacies
DENVER (AP) - Regulatory officials are studying whether Colorado should license Canadian pharmacies so residents can buy cheaper prescription drugs.
The Colorado Department of Regulatory Agencies will publish its recommendations in October at the request of lawmakers, said agency director Rick O'Donnell. Consumer advocates had pushed the issue during the legislative session.
Groups argued that licensing would force hold pharmacies to U.S. drug standards, and that patients who purchase drugs online or through the mail could get safe medications and access to cheap prescriptions.
The Colorado Pharmacists Society has cautioned consumers against buying imported drugs because the Food and Drug Administration doesn't inspect them and can't guarantee such drugs are safe.
The FDA generally bars consumers from bringing drugs into the country that it has not approved.
Some state officials worry that by licensing Canadian pharmacies, the state would be endorsing illegal behavior, said Matt Mayer, deputy director of the Colorado Department of Regulatory Agencies.
''You're asking us to put our head in the sand,'' he said.
Canada's state-sponsored health care system imposes cost-controls on prescription drugs. Pharmacies can sell drugs at 50 percent less than U.S. pharmacies.
If the state cracks down on the purchase of Canadian drugs, low-income seniors in particular might turn to less reliable sources for affordable medications, said Laurie Kiusalaas, a spokeswoman for AARP Colorado.
''Seniors will go somewhere else if Canada dries up, like Mexico,'' Kiusalaas said.
But Colorado pharmacies that compete with Canada for business want to limit the amount of competition from north of the border
Prosecutor: Canadian drug sales no crime
By Phil Galewitz, Palm Beach Post Staff Writer
Thursday, May 29, 2003
Palm Beach County State Attorney Barry Krischer has given a green light to local storefront businesses that are selling discounted prescription drugs from Canada, even though state health officials say the practice is illegal and dangerous.
"There is not any crime being committed here," Krischer's spokesman, Mike Edmondson, told The Palm Beach Post this week.
Krischer's office reviewed the storefront operations this spring after getting complaints from local pharmacies that they were losing sales to the storefronts selling Canadian drugs.
Krischer saw fit to rule on the controversial issue even though he hasn't received the results of the state Health Department's investigation. He said that because the storefronts merely facilitate the filling of legitimate prescriptions through Canadian pharmacies, the businesses are not operating as unlicensed pharmacies, as the state Health Department has alleged.
Although Krischer's jurisdiction ends at the county line, his decision is significant for two reasons:
He's the first of 20 state attorneys in Florida to rule publicly on the issue.
The state Health Department could not take criminal action against a Palm Beach County business without the assistance of a state attorney or the Florida Attorney General's Office.
A spokesman for Attorney General Charlie Crist said he is not now looking into the matter.
The issue of reimporting American-made drugs from Canada is a contentious and increasingly important one because of the large and growing number of Americans getting their medications through Canada.
An estimated $2 billion to $4 billion in prescription drugs is coming over the border annually through storefronts or via the Internet. More than 100 such stores have opened around the country in the past year, and many more are expected to open soon as U.S. seniors become increasingly frustrated with high prescription drug costs here.
Because of price controls, medications in Canada cost up to 70 percent less than the same drugs in the United States.
"This is a really just and unbiased ruling by the state attorney, and my hat's off to him," said Earle Turow, owner of Delray Beach-based Discount Drugs of Canada, believed to be the largest U.S. operator of Canadian drugstores, with 43 stores nationwide, including 20 in Florida.
Since he opened his first store in Delray Beach last October, Turow's nondescript storefronts have generated millions of prescriptions in Palm Beach County that are filled by Canadian pharmacies. "This validates our point that we are not operating as a pharmacy," Turow said.
State health officials disagree. They have been investigating the Canadian storefront operations here since last year, after Turow and a handful of other entrepreneurs began opening the businesses.
The stores don't stock any medicines, but take prescription orders that are sent to Canada. The drugs are delivered by mail directly to the patient's home.
The Health Department has warned that the drugs from Canada are not regulated and could be prone to tampering, improper handling or storage.
While Florida officials have investigated, the number of storefronts reported to operate across the state has grown from six to 40 in the last six months. They are now operating in Boca Raton, West Palm Beach, Palm Beach Gardens, Delray Beach and Boynton Beach.
So far, there have been no reports of anyone being harmed by drugs purchased from Canada through U.S. stores.
Some industry observers think the state is holding off on action to close the storefronts because Gov. Jeb Bush does not want to upset thousands of Florida seniors on the eve of his brother's upcoming presidential reelection campaign.
Health Department spokesman Bill Parizek denies politics are affecting the speed of the investigation.
"Gathering information for a potential criminal activity is time-consuming," he said.
Parizek said the Health Department has not formally presented the findings from its investigation to Krischer.
"We have not been told by the Palm Beach attorney that he wouldn't do anything," Parizek said.
Krischer himself faces reelection in November 2004. Through his spokesman, Krischer denies his ruling on the storefronts is politically motivated.
While reimporting medications from abroad is technically illegal in the United States, the Food and Drug Administration and law enforcement agencies have generally not interfered with efforts by individuals to buy drugs from Canada.
But at the urging of the U.S. pharmaceutical industry, the agencies are becoming increasingly aggressive about targeting groups and businesses that encourage or profit from the Canadian trade.
Congress has twice passed bills legalizing the reimportation of drugs from Canada. However, both times the secretary of Health and Human Services said the agency could not vouch for the drugs' safety, and so the bills died
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