Congress Looks to Foreign Imports...
Congress Looks to Foreign Imports...
As the debate over a Medicare drug benefit continues and policy makers seek a cure for high medication costs, each house of Congress recently passed a "Band-Aid" to help heal the nation's high drug prices. The Band-Aid in both proposals is simple: open the borders between the United States and Canada and Mexico to allow access to the lower prescription drug prices in those other countries. The two approaches are quite different, however, and neither is without significant problems.
The House Approach: Personal Importation
In an amendment to the Agriculture Appropriations Bill (the bill funding a number of federal agencies, including FDA), the House of Representatives added a measure prohibiting FDA from using any funds to enforce the prohibition on re-importing medications found in the Federal Food, Drug, and Cosmetic (FD&C) Act. Currently the FD&C Act allows only the manufacturer of a prescription medication produced in the United States, then subsequently exported, to bring the medication back into the United States. Additionally, the bill prohibits FDA from spending any money to interfere with the importation of FDA-approved drugs manufactured in an FDA-approved facility in the United States, Canada, or Mexico.
What does this mean? Essentially, this bill allows individual patients to import approved medications, without fear of reprisal from FDA. Not that FDA has traditionally knocked on doors and inspected consumers' medicine cabinets, but the potential for enforcement is real. The U.S. Customs Service recently reported a substantial increase in the number of packages with prescription medications coming across the border. The Customs Service forwards some of these packages to consumers with a letter explaining the illegal nature of importing medications. Few consumers realize that ordering an allergy medication or impotence treatment online from an international pharmacy is technically a violation of federal law. By prohibiting the enforcement of the law, however, the House leaves the law intact in name only.
More important, however, is that many consumers do not know the risks of taking the medication imported in technical violation of the law. Despite some lawmakers' assertions that the ban on re-importation was a "sweetheart deal" to protect the industry and pharmacists, the limits on re-importation were based on legitimate concerns for product quality and integrity. While some of the products are manufactured in the United States, with the same quality controls, there are no limits on the conditions for shipping products after leaving the country or for labeling the products for consumer use. The risks for contamination and product damage are real, as is the potential for error if medications arrive without sufficient information to confirm appropriate use. Additionally, attempts to monitor for drug interactions are thwarted when the pharmacist does not know about the patient's full therapy. It is unlikely that patients getting medications from international pharmacies will be completely frank with their local pharmacists about their complete medication profiles. Medications from international sources are not likely to meet domestic labeling and packaging requirements, increasing the potential for medication errors and misuse.
To the Senate Side...
The Agriculture Appropriations Bill also became the vehicle for Senate discussion of the re-importation issue. In a significantly different approach, the Senate language allows pharmacists and wholesalers to import FDA-approved medications from foreign countries. Additionally, the Department of Health and Human Services (HHS) would be required to develop regulations to ensure the safety of imported drugs -- specifically to ensure that the importation practice poses no more risk for patients than the current domestic regulation of the pharmaceutical industry.
Pharmacists and wholesalers importing medications would be required to provide documentation of manufacturing in an FDA-approved facility, the chain of custody, and tests confirming the authenticity and absence of degradation of the medication. Many people have speculated that these requirements -- in addition to requirements in the HHS regulations to ensure no more risk with imported products than under the current system -- will impose costs that offset the differential between foreign and U.S. prices.
The Senate approach addresses many of the concerns in the House bill. By allowing pharmacists and wholesalers to re-import the medications, consumers can continue to use their local pharmacists, supporting better monitoring for interactions and preserving access to pharmacists' medication therapy management services. And the sampling requirements provide some assurance of product quality, decreasing the potential for adulterated or counterfeit products. Tracking the pedigree of the product -- where it's been and who has had it -- will limit some "gray-market" activity.
Skeptics, however, argue that each of these protections can be circumvented, and that the requirement for analytical testing could absorb any price benefit. Further, one must ask why we have an extensive regulatory system for drug approval, manufacturing, prescribing, and dispensing, if the different systems in Canada or Mexico are sufficient for those patients seeking lower-cost medications. Are we setting up a system where only a few patients will be able to afford medications meeting high U.S. standards, while most people can settle for a lower-quality, and lower-priced, product? Obviously, we must ensure that attempts to lower medication costs will not come at the expense of quality health care.
Another Wrong Answer?
Importantly, these proposals continue to focus only on the initial cost of medications and ignore the reality that the most expensive medication is the one that does not work. Paying for medication that does not cure the infection because it is the wrong antibiotic or medication that doesn't lower cholesterol levels because the patient stopped taking it is a waste. Pharmacists must continue to share this message, and make sure that consumers and policy makers know that there is more to medication use than finding the cheapest product.
As the debate over a Medicare drug benefit continues and policy makers seek a cure for high medication costs, each house of Congress recently passed a "Band-Aid" to help heal the nation's high drug prices. The Band-Aid in both proposals is simple: open the borders between the United States and Canada and Mexico to allow access to the lower prescription drug prices in those other countries. The two approaches are quite different, however, and neither is without significant problems.
The House Approach: Personal Importation
In an amendment to the Agriculture Appropriations Bill (the bill funding a number of federal agencies, including FDA), the House of Representatives added a measure prohibiting FDA from using any funds to enforce the prohibition on re-importing medications found in the Federal Food, Drug, and Cosmetic (FD&C) Act. Currently the FD&C Act allows only the manufacturer of a prescription medication produced in the United States, then subsequently exported, to bring the medication back into the United States. Additionally, the bill prohibits FDA from spending any money to interfere with the importation of FDA-approved drugs manufactured in an FDA-approved facility in the United States, Canada, or Mexico.
What does this mean? Essentially, this bill allows individual patients to import approved medications, without fear of reprisal from FDA. Not that FDA has traditionally knocked on doors and inspected consumers' medicine cabinets, but the potential for enforcement is real. The U.S. Customs Service recently reported a substantial increase in the number of packages with prescription medications coming across the border. The Customs Service forwards some of these packages to consumers with a letter explaining the illegal nature of importing medications. Few consumers realize that ordering an allergy medication or impotence treatment online from an international pharmacy is technically a violation of federal law. By prohibiting the enforcement of the law, however, the House leaves the law intact in name only.
More important, however, is that many consumers do not know the risks of taking the medication imported in technical violation of the law. Despite some lawmakers' assertions that the ban on re-importation was a "sweetheart deal" to protect the industry and pharmacists, the limits on re-importation were based on legitimate concerns for product quality and integrity. While some of the products are manufactured in the United States, with the same quality controls, there are no limits on the conditions for shipping products after leaving the country or for labeling the products for consumer use. The risks for contamination and product damage are real, as is the potential for error if medications arrive without sufficient information to confirm appropriate use. Additionally, attempts to monitor for drug interactions are thwarted when the pharmacist does not know about the patient's full therapy. It is unlikely that patients getting medications from international pharmacies will be completely frank with their local pharmacists about their complete medication profiles. Medications from international sources are not likely to meet domestic labeling and packaging requirements, increasing the potential for medication errors and misuse.
To the Senate Side...
The Agriculture Appropriations Bill also became the vehicle for Senate discussion of the re-importation issue. In a significantly different approach, the Senate language allows pharmacists and wholesalers to import FDA-approved medications from foreign countries. Additionally, the Department of Health and Human Services (HHS) would be required to develop regulations to ensure the safety of imported drugs -- specifically to ensure that the importation practice poses no more risk for patients than the current domestic regulation of the pharmaceutical industry.
Pharmacists and wholesalers importing medications would be required to provide documentation of manufacturing in an FDA-approved facility, the chain of custody, and tests confirming the authenticity and absence of degradation of the medication. Many people have speculated that these requirements -- in addition to requirements in the HHS regulations to ensure no more risk with imported products than under the current system -- will impose costs that offset the differential between foreign and U.S. prices.
The Senate approach addresses many of the concerns in the House bill. By allowing pharmacists and wholesalers to re-import the medications, consumers can continue to use their local pharmacists, supporting better monitoring for interactions and preserving access to pharmacists' medication therapy management services. And the sampling requirements provide some assurance of product quality, decreasing the potential for adulterated or counterfeit products. Tracking the pedigree of the product -- where it's been and who has had it -- will limit some "gray-market" activity.
Skeptics, however, argue that each of these protections can be circumvented, and that the requirement for analytical testing could absorb any price benefit. Further, one must ask why we have an extensive regulatory system for drug approval, manufacturing, prescribing, and dispensing, if the different systems in Canada or Mexico are sufficient for those patients seeking lower-cost medications. Are we setting up a system where only a few patients will be able to afford medications meeting high U.S. standards, while most people can settle for a lower-quality, and lower-priced, product? Obviously, we must ensure that attempts to lower medication costs will not come at the expense of quality health care.
Another Wrong Answer?
Importantly, these proposals continue to focus only on the initial cost of medications and ignore the reality that the most expensive medication is the one that does not work. Paying for medication that does not cure the infection because it is the wrong antibiotic or medication that doesn't lower cholesterol levels because the patient stopped taking it is a waste. Pharmacists must continue to share this message, and make sure that consumers and policy makers know that there is more to medication use than finding the cheapest product.
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