For all of the lengthy efforts made to educate and track patients who take isotretinoin (Accutane) to prevent pregnancies, and consequently, severe birth defects, it’s hard to believe that this drug can be so easily imported from other countries — and without a prescription. Last September, the FDA issued a warning letter to Internet companies that were selling an illegal, mislabeled version of isotretinoin without requiring a prescription. The drug was sold as a gel via the Internet companies, and the drug’s labeling was in a foreign language. In cases such as this one, the danger is obvious, as these patients were undoubtedly out of radar range of programs such as the System to Manage Accutane Related Teratogenicity (SMART) program. But this is but one example illustrating the dangers of obtaining drugs from foreign sources via the Internet. “I recall one serious case where a patient of mine had developed a severe case of a steroid-induced rosaceaform eruption,” explains James Q. Del Rosso, D.O., F.A.O.C.D., a dermatologist in private practice in Nevada. “The patient developed the condition after obtaining a high-potency corticosteroid via the Internet without a prescription,” Dr. Del Rosso continues. “The patient used the drug for months on the face, and it took several months to improve with therapy. The patient also had significant problems with rebound flare.” It’s clear that problems may occur when patients obtain medications over the Internet without a prescription. When the element of a foreign source for the medications is added, the potential for problems can increase, as was the case with the foreign language labeling with the isotretinoin product mentioned above. The Internet is but one major source for reimporting drugs, but it’s an important one since prescriptions are not always required. Is Drug Reimportation Really a problem? According to an Associated Press report in late September of last year, a special crackdown on drug imports found that 90% of imported mail-order drugs were potentially dangerous. The investigation, which was headed by the FDA and Customs agents, involved drugs collected at international mail centers in New York, Miami, San Francisco and Carson, CA. Of the 1,153 imported drugs collected by agents, 1,019 were deemed illegal. The drugs were illegal for a number of reasons including the following: • The drugs had been withdrawn from the U.S. market. • They were animal drugs that had never been approved for humans. • Some of the drugs were counterfeit. • Some of the drugs had the potential to cause dangerous interactions, or they could cause dangerous adverse events. • They were narcotics. Of the drugs seized in the crackdown, 15.8% had been imported from Canada and 14.3% were from India. Other countries included Thailand, the Philippines, Brazil, China, Mexico, Peru, Fiji, the United Kingdom, Costa Rico and Vanuatu. Other reports have indicated that the risk of injury to consumers when importing prescription drugs is low. “While the FDA is limiting Canadian drugs purportedly for safety reasons,” says Phillip Williford, M.D., of Wake Forest University, “I think most people believe it is the politics of drug pricing that is driving that effort. I think it’s both.” The Issue At a Glance There are a variety of ways that people can purchase drugs from sources outside of the United States. First, they can go overseas and buy the medications or have an agent buy them overseas and ship them to the United States. They can be obtained via phone, fax or mail requests for drugs along with payment to overseas providers. Or, people can use the Internet to access any one of literally thousands of overseas Web sites that are offering virtually all medications at discount rates. Is this practice legal? The short answer is “no.” In most cases it is illegal. The FDA has strict regulations against importing in drugs from other countries. However, a few loopholes exist. One of which is called the personal use exception. Under that exception, the FDA will allow individuals to bring in a 90-day supply of medications from overseas. Of course, there’s one large hole in the system and that is that the FDA has not actively enforced the ban against drug reimportation, at least not until very recently. Prodded by the pharmaceutical industry, physicians and the dramatic rise the in the number of drugs that are being reimported, the FDA has begun to crack down on the practice. At present, the American Academy of Dermatology (AAD) has not yet established an official position on drug reimportation. A spokesperson said that the organization is currently formulating a position, which it expects to make public in the very near future. It’s likely that the organization will take a firm stand against the use of reimported medications and overseas Internet sales primarily because of the safety issues. The AAD Association (AADA), which tracks government affairs for the AAD, recently issued a statement calling for the FDA to ban the Internet sales of isotretinoin, which can be obtained over the Internet without a prescription from overseas pharmacies. “The sale of isotretinoin over the Internet is not only a serious public health concern, it undermines the ability of the FDA to assess the success of the regulatory program in place for this drug,” warned AADA President Raymond L. Cornelison Jr., M.D., in the statement. “While patients may be able to save time or money by directly purchasing isotretinoin from Internet vendors, the benefits certainly don’t outweigh the risks of taking this powerful medication without proper medical supervision.” What’s the Main Opposition? Why are groups opposed to drug reimportation? Physicians, including dermatologists, oppose drug reimportation primarily for safety reasons. “I want to make sure that my patients take the medications that they are supposed to take,” says Dr. Del Rosso. “While I’m sensitive to the fact that medications can be expensive, I also understand that there are risks in buying drugs from an overseas pharmacy or through the Internet. I have seen patients who had problems with medications they purchased overseas or through the Internet.” The FDA has long opposed the reimportation of drugs, but has lacked the resources necessary to police the growing problem and put a stop to the illegal trade in reimported drugs. In an effort to make the public more aware of the potential dangers of imported drugs, the FDA has begun to publicize instances where individuals who purchased reimported medications had significant problems with the drugs that they received. Going a step further, in February, the FDA took action against three foreign-based Web sites that sold counterfeit versions of Johnson & Johnson’s Ortho Evra contraceptive patch. The fake patches contained no active ingredients and did not offer any protection against pregnancy or any of the beneficial side effects that cause dermatologists to prescribe them for acne patients. The move by the FDA follows similar action against another foreign Web site that also was selling fake patches. “Because there is no regulation of overseas suppliers, there is no way to guarantee that a medication that you have received from an overseas source is either the medication that you ordered, that it is the proper dosage, or that it is packaged with the correct instructions,” says Wanda Mobius, a spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA), a pharmaceutical trade association. “Moreover, there is no way to know if a shipment was handled properly, and not subject to extreme conditions that might compromise its efficacy. We know of cases where insulin was not kept refrigerated during shipping, which means that it may be totally ineffective.” All of the warnings from the FDA, physicians and others have seemingly fallen on deaf ears. The number of people who are purchasing medications overseas for reimportation, either through Web sites or by traveling themselves is exploding. According to industry analysts, reimportation of drugs from Canada alone amounts to $1.1 billion in 2003, an amount that was up 11.5% from the previous year. However, as large as that number is, it represents less than one half a percent of the total $216.4 billion in total U.S. prescription sales in 2003. Despite sharp warning and the new level of enforcement by the FDA, the risk to individuals from reimported drugs appears, at least those from Canada, to be less than the risk associated with your neighborhood pharmacy. Only a small handful of individuals have reported injury as a result of receiving the wrong medications from Canadian pharmacies. While this shows that there are risks, the small number also indicates that the medications from Canada appear to be safe on the whole. But even prescriptions from American pharmacies are subject to risk. Studies in this country show that pharmacies make mistakes in about 3% of prescriptions. A genuine concern, however, is that an Internet drug supplier may claim to be Canadian, but in several instances, that has not proven to be true, so a consumer who may feel safe ordering from an online pharmacy because they think it is Canadian, my actually be getting their medications from some other country. It All Comes Down to Cost Many buyers who go overseas say that they do so for cost savings — with some number doing so to get medications without a prescription. But, are overseas medications really that much cheaper than medications purchased in the United States? A quick comparison of local and online pharmacies based in the United States, a few Canadian pharmacies and online pharmacies that are based in other countries showed that many medications were often significantly cheaper when purchased through the overseas pharmacies. For example, 100 mg and 200 mg tablets of the anti-fungal ketoconazole (Nizoral) cost anywhere from $345 to $425 in the United States but could be purchased for about $156 from Canadian pharmacies, a clear and substantial savings. Additionally, the medication could be purchased from a Web site that claimed to be based in New Zealand for an even cheaper $133. Of course, shipping charges have to be calculated into these cost, but on examination they were often free or only a few dollars. (For more examples of drug pricing, see the table “Comparing Costs” below.) Obviously, the overseas purchases of the medication represent a substantial savings, but, 100 mg to 200 mg tablets of the generic ketoconazole could be purchased in the United States for less than $50. Of course, not all drugs are available in their generic form, but not all drugs are available on the overseas market. In fact, many U.S. manufactured drugs can’t be purchased at any price in Canada. Cracking Down Not only has the FDA begun to crack down on drug reimportation, but also many of the drug makers have begun to limit shipments to Canada of drugs that are being reimported to this country. AstraZeneca, GlaxoSmithKline, Pfizer and Wyeth all have policies under which they will not sell products to Canadian pharmacies and wholesalers that market the products online to the United States and other nations. In response to public pressure to lower drug prices, the House of Representatives passed the Pharmaceutical Market Access Act of 2003, which, if it became law, would legalize much of the drug reimportation that is going on illegally now. However, the Senate has yet to consider the issue and no drug reimportation bills have been formally submitted. Even if the Senate did pass a bill of its own, the Bush administration has made it clear that the President would likely veto any measure that legalizes drug reimportation. Predictably, the American drug makers are strongly opposed to all drug reimportation, as are many physicians. Defending the high cost of prescription drugs, the industry cites high research and development costs coupled with strict price controls in many foreign countries as reasons for higher prices that Americans pay. “In effect, Americans are subsidizing the cost of medications overseas,” says Ms. Mobius. “Instead of calling for drug reimportation, we should be calling for foreign nations to raise their prices to a more equitable level.” Addressing the Issue Open any newspaper today and the issue of drug reimportation is at the forefront. The climate now seems to be moving toward a middle ground — where pricing issues are addressed as well as safety concerns. With the recent formation of the U.S. Department of Health and Human Resources’ task force set to explore the impact (both positive and negative) on Americans’ health, medical costs and the development of new medicines, this issue is sure to have a continuing effect on patients.
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Drug Reimportation
For all of the lengthy efforts made to educate and track patients who take isotretinoin (Accutane) to prevent pregnancies, and consequently, severe birth defects, it’s hard to believe that this drug can be so easily imported from other countries — and without a prescription. Last September, the FDA issued a warning letter to Internet companies that were selling an illegal, mislabeled version of isotretinoin without requiring a prescription. The drug was sold as a gel via the Internet companies, and the drug’s labeling was in a foreign language. In cases such as this one, the danger is obvious, as these patients were undoubtedly out of radar range of programs such as the System to Manage Accutane Related Teratogenicity (SMART) program. But this is but one example illustrating the dangers of obtaining drugs from foreign sources via the Internet. “I recall one serious case where a patient of mine had developed a severe case of a steroid-induced rosaceaform eruption,” explains James Q. Del Rosso, D.O., F.A.O.C.D., a dermatologist in private practice in Nevada. “The patient developed the condition after obtaining a high-potency corticosteroid via the Internet without a prescription,” Dr. Del Rosso continues. “The patient used the drug for months on the face, and it took several months to improve with therapy. The patient also had significant problems with rebound flare.” It’s clear that problems may occur when patients obtain medications over the Internet without a prescription. When the element of a foreign source for the medications is added, the potential for problems can increase, as was the case with the foreign language labeling with the isotretinoin product mentioned above. The Internet is but one major source for reimporting drugs, but it’s an important one since prescriptions are not always required. Is Drug Reimportation Really a problem? According to an Associated Press report in late September of last year, a special crackdown on drug imports found that 90% of imported mail-order drugs were potentially dangerous. The investigation, which was headed by the FDA and Customs agents, involved drugs collected at international mail centers in New York, Miami, San Francisco and Carson, CA. Of the 1,153 imported drugs collected by agents, 1,019 were deemed illegal. The drugs were illegal for a number of reasons including the following: • The drugs had been withdrawn from the U.S. market. • They were animal drugs that had never been approved for humans. • Some of the drugs were counterfeit. • Some of the drugs had the potential to cause dangerous interactions, or they could cause dangerous adverse events. • They were narcotics. Of the drugs seized in the crackdown, 15.8% had been imported from Canada and 14.3% were from India. Other countries included Thailand, the Philippines, Brazil, China, Mexico, Peru, Fiji, the United Kingdom, Costa Rico and Vanuatu. Other reports have indicated that the risk of injury to consumers when importing prescription drugs is low. “While the FDA is limiting Canadian drugs purportedly for safety reasons,” says Phillip Williford, M.D., of Wake Forest University, “I think most people believe it is the politics of drug pricing that is driving that effort. I think it’s both.” The Issue At a Glance There are a variety of ways that people can purchase drugs from sources outside of the United States. First, they can go overseas and buy the medications or have an agent buy them overseas and ship them to the United States. They can be obtained via phone, fax or mail requests for drugs along with payment to overseas providers. Or, people can use the Internet to access any one of literally thousands of overseas Web sites that are offering virtually all medications at discount rates. Is this practice legal? The short answer is “no.” In most cases it is illegal. The FDA has strict regulations against importing in drugs from other countries. However, a few loopholes exist. One of which is called the personal use exception. Under that exception, the FDA will allow individuals to bring in a 90-day supply of medications from overseas. Of course, there’s one large hole in the system and that is that the FDA has not actively enforced the ban against drug reimportation, at least not until very recently. Prodded by the pharmaceutical industry, physicians and the dramatic rise the in the number of drugs that are being reimported, the FDA has begun to crack down on the practice. At present, the American Academy of Dermatology (AAD) has not yet established an official position on drug reimportation. A spokesperson said that the organization is currently formulating a position, which it expects to make public in the very near future. It’s likely that the organization will take a firm stand against the use of reimported medications and overseas Internet sales primarily because of the safety issues. The AAD Association (AADA), which tracks government affairs for the AAD, recently issued a statement calling for the FDA to ban the Internet sales of isotretinoin, which can be obtained over the Internet without a prescription from overseas pharmacies. “The sale of isotretinoin over the Internet is not only a serious public health concern, it undermines the ability of the FDA to assess the success of the regulatory program in place for this drug,” warned AADA President Raymond L. Cornelison Jr., M.D., in the statement. “While patients may be able to save time or money by directly purchasing isotretinoin from Internet vendors, the benefits certainly don’t outweigh the risks of taking this powerful medication without proper medical supervision.” What’s the Main Opposition? Why are groups opposed to drug reimportation? Physicians, including dermatologists, oppose drug reimportation primarily for safety reasons. “I want to make sure that my patients take the medications that they are supposed to take,” says Dr. Del Rosso. “While I’m sensitive to the fact that medications can be expensive, I also understand that there are risks in buying drugs from an overseas pharmacy or through the Internet. I have seen patients who had problems with medications they purchased overseas or through the Internet.” The FDA has long opposed the reimportation of drugs, but has lacked the resources necessary to police the growing problem and put a stop to the illegal trade in reimported drugs. In an effort to make the public more aware of the potential dangers of imported drugs, the FDA has begun to publicize instances where individuals who purchased reimported medications had significant problems with the drugs that they received. Going a step further, in February, the FDA took action against three foreign-based Web sites that sold counterfeit versions of Johnson & Johnson’s Ortho Evra contraceptive patch. The fake patches contained no active ingredients and did not offer any protection against pregnancy or any of the beneficial side effects that cause dermatologists to prescribe them for acne patients. The move by the FDA follows similar action against another foreign Web site that also was selling fake patches. “Because there is no regulation of overseas suppliers, there is no way to guarantee that a medication that you have received from an overseas source is either the medication that you ordered, that it is the proper dosage, or that it is packaged with the correct instructions,” says Wanda Mobius, a spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA), a pharmaceutical trade association. “Moreover, there is no way to know if a shipment was handled properly, and not subject to extreme conditions that might compromise its efficacy. We know of cases where insulin was not kept refrigerated during shipping, which means that it may be totally ineffective.” All of the warnings from the FDA, physicians and others have seemingly fallen on deaf ears. The number of people who are purchasing medications overseas for reimportation, either through Web sites or by traveling themselves is exploding. According to industry analysts, reimportation of drugs from Canada alone amounts to $1.1 billion in 2003, an amount that was up 11.5% from the previous year. However, as large as that number is, it represents less than one half a percent of the total $216.4 billion in total U.S. prescription sales in 2003. Despite sharp warning and the new level of enforcement by the FDA, the risk to individuals from reimported drugs appears, at least those from Canada, to be less than the risk associated with your neighborhood pharmacy. Only a small handful of individuals have reported injury as a result of receiving the wrong medications from Canadian pharmacies. While this shows that there are risks, the small number also indicates that the medications from Canada appear to be safe on the whole. But even prescriptions from American pharmacies are subject to risk. Studies in this country show that pharmacies make mistakes in about 3% of prescriptions. A genuine concern, however, is that an Internet drug supplier may claim to be Canadian, but in several instances, that has not proven to be true, so a consumer who may feel safe ordering from an online pharmacy because they think it is Canadian, my actually be getting their medications from some other country. It All Comes Down to Cost Many buyers who go overseas say that they do so for cost savings — with some number doing so to get medications without a prescription. But, are overseas medications really that much cheaper than medications purchased in the United States? A quick comparison of local and online pharmacies based in the United States, a few Canadian pharmacies and online pharmacies that are based in other countries showed that many medications were often significantly cheaper when purchased through the overseas pharmacies. For example, 100 mg and 200 mg tablets of the anti-fungal ketoconazole (Nizoral) cost anywhere from $345 to $425 in the United States but could be purchased for about $156 from Canadian pharmacies, a clear and substantial savings. Additionally, the medication could be purchased from a Web site that claimed to be based in New Zealand for an even cheaper $133. Of course, shipping charges have to be calculated into these cost, but on examination they were often free or only a few dollars. (For more examples of drug pricing, see the table “Comparing Costs” below.) Obviously, the overseas purchases of the medication represent a substantial savings, but, 100 mg to 200 mg tablets of the generic ketoconazole could be purchased in the United States for less than $50. Of course, not all drugs are available in their generic form, but not all drugs are available on the overseas market. In fact, many U.S. manufactured drugs can’t be purchased at any price in Canada. Cracking Down Not only has the FDA begun to crack down on drug reimportation, but also many of the drug makers have begun to limit shipments to Canada of drugs that are being reimported to this country. AstraZeneca, GlaxoSmithKline, Pfizer and Wyeth all have policies under which they will not sell products to Canadian pharmacies and wholesalers that market the products online to the United States and other nations. In response to public pressure to lower drug prices, the House of Representatives passed the Pharmaceutical Market Access Act of 2003, which, if it became law, would legalize much of the drug reimportation that is going on illegally now. However, the Senate has yet to consider the issue and no drug reimportation bills have been formally submitted. Even if the Senate did pass a bill of its own, the Bush administration has made it clear that the President would likely veto any measure that legalizes drug reimportation. Predictably, the American drug makers are strongly opposed to all drug reimportation, as are many physicians. Defending the high cost of prescription drugs, the industry cites high research and development costs coupled with strict price controls in many foreign countries as reasons for higher prices that Americans pay. “In effect, Americans are subsidizing the cost of medications overseas,” says Ms. Mobius. “Instead of calling for drug reimportation, we should be calling for foreign nations to raise their prices to a more equitable level.” Addressing the Issue Open any newspaper today and the issue of drug reimportation is at the forefront. The climate now seems to be moving toward a middle ground — where pricing issues are addressed as well as safety concerns. With the recent formation of the U.S. Department of Health and Human Resources’ task force set to explore the impact (both positive and negative) on Americans’ health, medical costs and the development of new medicines, this issue is sure to have a continuing effect on patients.
For all of the lengthy efforts made to educate and track patients who take isotretinoin (Accutane) to prevent pregnancies, and consequently, severe birth defects, it’s hard to believe that this drug can be so easily imported from other countries — and without a prescription. Last September, the FDA issued a warning letter to Internet companies that were selling an illegal, mislabeled version of isotretinoin without requiring a prescription. The drug was sold as a gel via the Internet companies, and the drug’s labeling was in a foreign language. In cases such as this one, the danger is obvious, as these patients were undoubtedly out of radar range of programs such as the System to Manage Accutane Related Teratogenicity (SMART) program. But this is but one example illustrating the dangers of obtaining drugs from foreign sources via the Internet. “I recall one serious case where a patient of mine had developed a severe case of a steroid-induced rosaceaform eruption,” explains James Q. Del Rosso, D.O., F.A.O.C.D., a dermatologist in private practice in Nevada. “The patient developed the condition after obtaining a high-potency corticosteroid via the Internet without a prescription,” Dr. Del Rosso continues. “The patient used the drug for months on the face, and it took several months to improve with therapy. The patient also had significant problems with rebound flare.” It’s clear that problems may occur when patients obtain medications over the Internet without a prescription. When the element of a foreign source for the medications is added, the potential for problems can increase, as was the case with the foreign language labeling with the isotretinoin product mentioned above. The Internet is but one major source for reimporting drugs, but it’s an important one since prescriptions are not always required. Is Drug Reimportation Really a problem? According to an Associated Press report in late September of last year, a special crackdown on drug imports found that 90% of imported mail-order drugs were potentially dangerous. The investigation, which was headed by the FDA and Customs agents, involved drugs collected at international mail centers in New York, Miami, San Francisco and Carson, CA. Of the 1,153 imported drugs collected by agents, 1,019 were deemed illegal. The drugs were illegal for a number of reasons including the following: • The drugs had been withdrawn from the U.S. market. • They were animal drugs that had never been approved for humans. • Some of the drugs were counterfeit. • Some of the drugs had the potential to cause dangerous interactions, or they could cause dangerous adverse events. • They were narcotics. Of the drugs seized in the crackdown, 15.8% had been imported from Canada and 14.3% were from India. Other countries included Thailand, the Philippines, Brazil, China, Mexico, Peru, Fiji, the United Kingdom, Costa Rico and Vanuatu. Other reports have indicated that the risk of injury to consumers when importing prescription drugs is low. “While the FDA is limiting Canadian drugs purportedly for safety reasons,” says Phillip Williford, M.D., of Wake Forest University, “I think most people believe it is the politics of drug pricing that is driving that effort. I think it’s both.” The Issue At a Glance There are a variety of ways that people can purchase drugs from sources outside of the United States. First, they can go overseas and buy the medications or have an agent buy them overseas and ship them to the United States. They can be obtained via phone, fax or mail requests for drugs along with payment to overseas providers. Or, people can use the Internet to access any one of literally thousands of overseas Web sites that are offering virtually all medications at discount rates. Is this practice legal? The short answer is “no.” In most cases it is illegal. The FDA has strict regulations against importing in drugs from other countries. However, a few loopholes exist. One of which is called the personal use exception. Under that exception, the FDA will allow individuals to bring in a 90-day supply of medications from overseas. Of course, there’s one large hole in the system and that is that the FDA has not actively enforced the ban against drug reimportation, at least not until very recently. Prodded by the pharmaceutical industry, physicians and the dramatic rise the in the number of drugs that are being reimported, the FDA has begun to crack down on the practice. At present, the American Academy of Dermatology (AAD) has not yet established an official position on drug reimportation. A spokesperson said that the organization is currently formulating a position, which it expects to make public in the very near future. It’s likely that the organization will take a firm stand against the use of reimported medications and overseas Internet sales primarily because of the safety issues. The AAD Association (AADA), which tracks government affairs for the AAD, recently issued a statement calling for the FDA to ban the Internet sales of isotretinoin, which can be obtained over the Internet without a prescription from overseas pharmacies. “The sale of isotretinoin over the Internet is not only a serious public health concern, it undermines the ability of the FDA to assess the success of the regulatory program in place for this drug,” warned AADA President Raymond L. Cornelison Jr., M.D., in the statement. “While patients may be able to save time or money by directly purchasing isotretinoin from Internet vendors, the benefits certainly don’t outweigh the risks of taking this powerful medication without proper medical supervision.” What’s the Main Opposition? Why are groups opposed to drug reimportation? Physicians, including dermatologists, oppose drug reimportation primarily for safety reasons. “I want to make sure that my patients take the medications that they are supposed to take,” says Dr. Del Rosso. “While I’m sensitive to the fact that medications can be expensive, I also understand that there are risks in buying drugs from an overseas pharmacy or through the Internet. I have seen patients who had problems with medications they purchased overseas or through the Internet.” The FDA has long opposed the reimportation of drugs, but has lacked the resources necessary to police the growing problem and put a stop to the illegal trade in reimported drugs. In an effort to make the public more aware of the potential dangers of imported drugs, the FDA has begun to publicize instances where individuals who purchased reimported medications had significant problems with the drugs that they received. Going a step further, in February, the FDA took action against three foreign-based Web sites that sold counterfeit versions of Johnson & Johnson’s Ortho Evra contraceptive patch. The fake patches contained no active ingredients and did not offer any protection against pregnancy or any of the beneficial side effects that cause dermatologists to prescribe them for acne patients. The move by the FDA follows similar action against another foreign Web site that also was selling fake patches. “Because there is no regulation of overseas suppliers, there is no way to guarantee that a medication that you have received from an overseas source is either the medication that you ordered, that it is the proper dosage, or that it is packaged with the correct instructions,” says Wanda Mobius, a spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA), a pharmaceutical trade association. “Moreover, there is no way to know if a shipment was handled properly, and not subject to extreme conditions that might compromise its efficacy. We know of cases where insulin was not kept refrigerated during shipping, which means that it may be totally ineffective.” All of the warnings from the FDA, physicians and others have seemingly fallen on deaf ears. The number of people who are purchasing medications overseas for reimportation, either through Web sites or by traveling themselves is exploding. According to industry analysts, reimportation of drugs from Canada alone amounts to $1.1 billion in 2003, an amount that was up 11.5% from the previous year. However, as large as that number is, it represents less than one half a percent of the total $216.4 billion in total U.S. prescription sales in 2003. Despite sharp warning and the new level of enforcement by the FDA, the risk to individuals from reimported drugs appears, at least those from Canada, to be less than the risk associated with your neighborhood pharmacy. Only a small handful of individuals have reported injury as a result of receiving the wrong medications from Canadian pharmacies. While this shows that there are risks, the small number also indicates that the medications from Canada appear to be safe on the whole. But even prescriptions from American pharmacies are subject to risk. Studies in this country show that pharmacies make mistakes in about 3% of prescriptions. A genuine concern, however, is that an Internet drug supplier may claim to be Canadian, but in several instances, that has not proven to be true, so a consumer who may feel safe ordering from an online pharmacy because they think it is Canadian, my actually be getting their medications from some other country. It All Comes Down to Cost Many buyers who go overseas say that they do so for cost savings — with some number doing so to get medications without a prescription. But, are overseas medications really that much cheaper than medications purchased in the United States? A quick comparison of local and online pharmacies based in the United States, a few Canadian pharmacies and online pharmacies that are based in other countries showed that many medications were often significantly cheaper when purchased through the overseas pharmacies. For example, 100 mg and 200 mg tablets of the anti-fungal ketoconazole (Nizoral) cost anywhere from $345 to $425 in the United States but could be purchased for about $156 from Canadian pharmacies, a clear and substantial savings. Additionally, the medication could be purchased from a Web site that claimed to be based in New Zealand for an even cheaper $133. Of course, shipping charges have to be calculated into these cost, but on examination they were often free or only a few dollars. (For more examples of drug pricing, see the table “Comparing Costs” below.) Obviously, the overseas purchases of the medication represent a substantial savings, but, 100 mg to 200 mg tablets of the generic ketoconazole could be purchased in the United States for less than $50. Of course, not all drugs are available in their generic form, but not all drugs are available on the overseas market. In fact, many U.S. manufactured drugs can’t be purchased at any price in Canada. Cracking Down Not only has the FDA begun to crack down on drug reimportation, but also many of the drug makers have begun to limit shipments to Canada of drugs that are being reimported to this country. AstraZeneca, GlaxoSmithKline, Pfizer and Wyeth all have policies under which they will not sell products to Canadian pharmacies and wholesalers that market the products online to the United States and other nations. In response to public pressure to lower drug prices, the House of Representatives passed the Pharmaceutical Market Access Act of 2003, which, if it became law, would legalize much of the drug reimportation that is going on illegally now. However, the Senate has yet to consider the issue and no drug reimportation bills have been formally submitted. Even if the Senate did pass a bill of its own, the Bush administration has made it clear that the President would likely veto any measure that legalizes drug reimportation. Predictably, the American drug makers are strongly opposed to all drug reimportation, as are many physicians. Defending the high cost of prescription drugs, the industry cites high research and development costs coupled with strict price controls in many foreign countries as reasons for higher prices that Americans pay. “In effect, Americans are subsidizing the cost of medications overseas,” says Ms. Mobius. “Instead of calling for drug reimportation, we should be calling for foreign nations to raise their prices to a more equitable level.” Addressing the Issue Open any newspaper today and the issue of drug reimportation is at the forefront. The climate now seems to be moving toward a middle ground — where pricing issues are addressed as well as safety concerns. With the recent formation of the U.S. Department of Health and Human Resources’ task force set to explore the impact (both positive and negative) on Americans’ health, medical costs and the development of new medicines, this issue is sure to have a continuing effect on patients.
