byJim Gifford
They cross the border at night and in broad daylight, singly and by the busload, not in the wilderness but at international airports and checkpoints on major highways. They know they will not be denied. Governors and congressional representatives encourage them.They are U.S. citizens foraging in Canada to save money on prescription drugs of all kinds, from Allegra to Zocor. This summer, according to charts posted on the Internet by Rep. Bernie Sanders for his Vermont constituents, they could save 58 percent buying Vioxx in Vancouver, or save 40 percent on Lipitor in Labrador, or similar amounts on other popular drugs just by hopping across the border to a neighborhood pharmacy in Canada.
When the roads get snowy in winter, Vermonters could even stay warm next to the pellet stove and use the Internet to arrange for a Canadian pharmacy to ship lower-priced medicines to them. Internet-based pharmacies, and Internet junk mail touting those pharmacies, are as prolific and persistent as crabgrass.The manufacturers of prescription drugs oppose the slowly rising tide of medicine that now enters the United States from Canada, and are bracing for the tsunami that may come in the form of Congressional approval. Several bills percolating in Washington would legalize prescription drug imports for individuals, and would allow U.S. pharmacists to purchase drugs abroad for domestic retail sale.
Some manufacturers are uncomfortable discussing the effects of cross-border prescription sales on their operations in the United States. A spokeswoman for Abbott Laboratories of Abbott Park, Ill., politely declined to comment and referred questions on importation to the industry’s Washington-based association, Pharmaceutical Research and Manufacturers of America. Rosemarie Yancosek, executive director of global communications for Schering-Plough in Kenilworth, N.J., said her company viewed importation as a safety threat but did not discuss any impact the practice might have on its pharmaceutical processing operations. “Schering-Plough remains opposed to the importation of prescription drugs into the U.S. from Canada or any other country. Even with increased safety measures, we still believe that importation would create a safety risk for consumers,” she said. Schering-Plough did not wish to comment further on the issue, she said.
GlaxoSmithKline’s Nancy Pekarek also led with a comment that prescription drug importing “presents a serious safety hazard to patients,” but she was willing to shed light on other effects of the practice within her company. Based in Philadelphia, Pekarek is the company’s vice president of corporate media relations for the U.S. market.
She said her company took particular issue with language in several Senate bills. If one or more of the bills should become law, drug producers would be compelled to fill orders from Canadian pharmacies that in turn would sell directly to U.S. customers. “Effectively, those positions would allow Congress to control the foreign marketing and manufacturing decisions of firms that market drugs in the U.S., which is an unprecedented intrusion of the government into international business activity,” she said. “There is no way that any company could say that they would not supply, say, Canada if there was an inordinate number of requests coming from Canada for medicines.”
Pekarek said the potential demand for lower-cost drugs from Canada “really dwarfs production levels that are geared to current local needs.” She noted that Canada’s population is about one-tenth that of the United States – there are more Californians than there are Canadians – but said under the proposed legislation, “Companies would have to supply countries like Canada up to the level of U.S .demand. And that would be tremendously disruptive to manufacturing and commercial planning and operations.” GlaxoSmithKline Canada stipulates in contracts with its customers that they sell to Canadian citizens in Canada. The company asked customers to certify that they were keeping to those terms. “Most did. Some did not,” Pekarek said. “As a result, we are not supplying those customers that we know are directly exporting medicines into the United States. And the impetus behind that was a concern for maintaining sufficient supply of medicines in Canada,” she said.
Some drugs are processed differently when intended for U.S. consumption than when shipped for sale elsewhere, she said. “In Canada, we have an asthma medicine that does not have to be overwrapped with a plastic wrap. That medicine, when supplied in the United States, does have to have an overwrap. The reason for that is that the Food and Drug Administration is concerned that if it is not wrapped in plastic, that it may have the possibility of absorbing moisture.” The drug, Advair, is inhaled as a powder. Pekarek said the FDA’s concern is that the powder might not disperse properly in a patient’s lungs, and therefore might not work as intended, if the powder gets moist or wet. “We don’t think there is an issue with moisture ingress [in the product even without an overwrap], but the FDA does, and the FDA is a regulatory authority,” Pekarek said.
“Let’s say loads of people from Florida decide to buy Advair from Canada. Well, they’re American citizens; the FDA requirement is for an overwrap. They’re ordering from Canada… that’s a Canada sale, so we wouldn’t normally provide the overwrap. You see the problem?”
Importation also increases the avenues through which counterfeit drugs could reach consumers, especially when the Internet is the channel for purchasing imported medicines, she said. “Just because a web site has a Canadian maple leaf on it, doesn’t mean it’s in Canada. The FDA has run enforcement actions and found that a number of these so-called Canadian pharmacies are actually registered outside Canada and outside the U.S., and medicines are coming in from everywhere. The Internet pharmacies are now openly contracting with countries like New Zealand, Australia, the United Kingdom and elsewhere to bring medicines in, because it’s even cheaper to go there. In a ‘buy low, sell higher’ situation the middle man is going to go where he can buy it for the lowest possible price, and if that’s Greece or Iran or Pakistan or somewhere else, that’s where they are going to go.”
U.S. pharmacists oppose consumer-level importation but are willing to consider commercial importation of drugs, where they remain gatekeepers watching for counterfeit or improperly handled medicines. Kristina Lunner, director of federal government affairs at the American Pharmacists Association in Washington, said pharmacists are “very concerned” that the Senate might follow the House of Representatives in passing a bill making it legal for individuals to import prescription medicines.
Lunner said one demographic group that will be particularly tempted by the cost savings from purchasing medications abroad is senior citizens with chronic illnesses. “Chronically ill patients usually have very complicated medication regimens. They often have more than one chronic disease. Pharmacists work very closely with those patients to make sure that each of their medications works best for them, and that patients stay compliant. Pharmacists definitely are a coach for patients… Their ability to continue to play that role will be dramatically hindered when and if personal importation is authorized.”Lunner conceded that senior citizens also flock to mail-order prescription delivery services that complicate a local pharmacists’ ability to see the whole medication picture. Communication between local and mail-order providers can break down, she said, “but there’s going to be more [communication] within a healthcare system than there is if you go to France, for example.”
The pharmacists do not object in principal to sales through Internet pharmacies, but Lunner said that channel poses a risk when the prescription is not written by a doctor who has seen the patient in person. “There are concerns when a patient can go to an Internet site and fill out a questionnaire, and that is turned into a quote-unquote valid prescription, which is then reviewed – perhaps – by a physician in a different country;” she said. “A prescription is written from that questionnaire and the medications are sent to the patient without any counseling, without any interaction. We do not support that. We oppose that.”
Transcription errors also could cause problems when individuals shop at foreign pharmacies, she said. “If you allow patients to fax or mail or hand-deliver a prescription that their U.S. physician – whom they’ve seen – has written for them, they [foreign pharmacists] have to transcribe it and there’s always room for human error. Not all drugs are named the same, and some drugs with very similar names are very different,” Lunner said.GlaxoSmithKline’s Pekarek noted that the FDA, boards of pharmacy and pharmacy associations have come out very strongly against importation. “All of those people are against importation. The experts. And yet there is still a popular view that importation is a good thing,” she said. “It’s a pricing issue at its root, but I do think there is a lack of understanding of the safety aspects of this.”
