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Armen Kazakov
Armen Kazakov

Buying Prescriptions From Canada

Mail-ordering drugs from a country outside the U.S., or buying them abroad and bringing them home, is and will remain illegal for consumers, according to emails from the Food and Drug Administration. (The only exception is for certain drugs, such as some cancer treatments, that are unavailable here.)

buying prescriptions from canada


The REMEDIES Act includes both a carrot and a stick to keep U.S. drug manufacturersfrom preventing legal importation. In order to claim either the existing advertising expensededuction or be eligible for a new 20 percent increase in the research and development tax credit,a company must certify that it has not taken any action during the taxable year to prevent orcondition the authorized importation of a qualified drug into the United States from a registeredexporter in accordance with the legislation.Grassley has been a consistent supporter of importing prescription drugs from Canada.The first reimportation vote in the U.S. Senate occurred in July 2000, on an amendment offeredby Sen. Jim Jeffords of Vermont. Grassley supported the Jeffords amendment. Grassley voted asecond time for reimportation of prescription drugs from Canada in July 2002, on an amendmentoffered by Sen. Byron Dorgan of North Dakota. Grassley voted for another Dorgan amendmentwhen it was offered in June 2003. This legislation became part of the Senate bill to add aprescription drug benefit to Medicare, but it was eliminated in the final conference report on thebill."This reimportation initiative would provide yet another option for senior citizens whowill enjoy the prescription drug benefits of the new Medicare program," Grassley said."Reimportation will benefit other consumers, as well."Grassley is chairman of the Senate Finance Committee. The bulk of his legislativeproposal falls within the jurisdiction of the Health, Education, Labor, and Pensions Committee.Grassley said he hopes to have his bill considered as part of the HELP Committee's action thisyear on prescription drug reimportation.The text of three documents follows here, including 1) FAQs about the REMEDIES Actof 2004, 2) an overview of key elements of the REMEDIES Act of 2004, and 3) Grassley's floorstatement marking introduction of the REMEDIES Act of 2004. A pdf file containing thelegislative language of the bill is available at FAQs about the REMEDIES Act of 2004Q: What are the goals of the legislation?A: The legislation has two objectives. First, it would put an immediate end to the unregulatedand unsafe situation with drug imports that exists today. Second, the legislation would providethe Food and Drug Administration (FDA) with the resources and authority to ensure the safety ofimported drugs.Q: How does the bill work?A: Current law prohibits the importation of prescription drugs until the Secretary of Health andHuman Services (HHS) certifies that importation can be done safely. Using current resourcesand authority, the FDA has not been able to provide an assurance of safety of imported drugs.The bill immediately halts unsafe importation but permits individuals to obtain prescriptionsfrom Canadian pharmacies on an interim basis while FDA gets the new drug importation systemup and running.Under the bill, the FDA is required to issue final regulations for the new system within 90 daysof enactment. Under the new importation system, individuals, pharmacies, and drug wholesalerscould purchase qualified drugs for import into the U.S. from foreign exporters that register withthe FDA. To obtain a registration, a foreign exporter must demonstrate compliance with safetymeasures, must submit to jurisdiction of U.S. courts, and take other steps to assure safety ofimported drugs. A user fee charged to registered exporters would provide the financing neededfor FDA to register and oversee foreign drug exporters and ensure the safety of imported drugs.Q: How will patients get their prescriptions filled at an overseas drug exporter?A: First of all, consumers that want to have their prescriptions filled at an overseas prescriptiondrug exporter will be able to go to the FDA website and find a list of companies that have passedFDA's requirements to become a registered exporter. Just as for filling a prescription in the, the patient must have a valid prescription written by a health care professional licensed ina state to prescribe drugs. The patient will then compare drug prices at the different registeredexporters to find the best price available. To get the prescription filled, the patient will have tocontact that exporter and either mail or fax the prescription to them.Alternatively, the registered exporter could call the patient's prescriber and get the prescriptionover the phone. This is the same process as mail order pharmacies in the U.S. use today.A pharmacist at the registered exporter would fill the prescription according to the prescriber'sinstructions. The registered exporter may only fill the prescription with brand-name drugs,meaning these are the same drugs as those approved by the FDA and manufactured by the samecompany as approved by the FDA for sale in the U.S.Individuals can also have a prescription filled that is technically not an FDA-approved drug, butthe drug must have the same active ingredients, dosage form, strength, and route ofadministration as the FDA-approved drug and is made by the same manufacturer as theFDA-approved drug. These drugs are manufactured by the same brand-name manufacturer andare made for sale in the market of the approved country.The registered exporter is required to verify that the drug can be traced back to the originalmanufacturer and the drug must have been stored and handled properly. The FDA, through itson-site inspectors, will also be verifying that the prescription drugs being dispensed to patientsmeet FDA's criteria.Once the prescription is filled, the registered exporter will place a label or other markings on thepackage for shipping that identify the shipment as being in compliance with FDA's safetyrequirements and all registration conditions. These markings will be designed by FDA and mayinclude track-and-trace technologies and anti-counterfeiting measures. When the package entersthe U.S., that marking will signify to Customs officials that the product was dispensed from aregistered exporter and can therefore be permitted to enter the country. Packages with drugs thatlack this marking will be seized by Customs and destroyed.Q: Can the importation of prescription drugs from other countries be expanded?A: Yes. In the second year of the importation program, HHS would be required to submit areport to Congress on the safety of the program and its impact on trade. Unless Congress acted,the program would be expanded in year three to include importation from the European Union,the European Free Trade Association, Japan, Australia and New Zealand. Other countries thatmeet specific statutory criteria may also be added to the list.Q: What is the complete list of countries that would be permitted in the third year of the program?A: There are currently 15 members of the European Union: Austria, Belgium, Denmark, Finland,France, Germany, Greece, Ireland, Italy, Luxembourg, Portugal, Spain, Sweden, TheNetherlands, and the United Kingdom. Beginning on May 1, 2004, there will be 10 new memberstates in the European Union: Cyprus, Czech Republic, Estonia, Hungary, Latvia, Lithuania,Malta, Poland, Slovakia, and Slovenia. There are 4 member countries in the European FreeTrade Association: Iceland, Liechtenstein, Norway, and Switzerland.Q: How much does this program cost?A: The infrastructure needed to guarantee the safety of the imported prescriptions would befinanced through user fees. User fees would be paid by registered exporters, which could be theoverseas pharmacies or prescription drug wholesalers, for example. The Congressional BudgetOffice has not yet officially scored the bill.Q: Now that the bill is introduced, what comes next?A: Because the bill contains tax provisions, it has been referred to the Finance Committee.Senate leadership has expressed an interest in developing legislation this year to allow theimportation of prescription drugs. Because the bulk of the legislation falls within thejurisdiction of the Health, Education, Labor & Pensions (HELP) Committee, it is expected thatHELP will take the lead in reporting any legislation.Q: How is this bill different than other legislation on importation?A: While the idea of importation of prescription drugs from foreign countries enjoys broadbipartisan support, the issue of safety continues to remain a major barrier to allowing importationto move forward. Secretaries of HHS from both the Clinton and Bush Administrations havedetermined that safe importation of prescription drugs cannot be guaranteed with the authorityand resources the FDA has today. Many bills presume that importation is safe and that FDA andthe public should not be overly alarmed. However, there is a legitimate concern about unsafepharmaceuticals entering the U.S. every day. Hundreds of thousands of packages enter ourcountry on a daily basis, with little or no ability for the U.S. Customs Service or the FDA toguarantee these drugs are safe and effective. Rather than ignore the safety issue, this billresponds to the concerns raised by FDA and others and creates a way to ensure safe access tolower cost prescriptions.Q: How does this bill lower the costs of prescription drugs Americans have to pay?A: United States consumers pay 30 to 300 percent more for their prescriptions drugs than thosein other countries. Drug manufacturers are forced to sell their products at lower prices in othercountries and try to re-coup their profits by making Americans pay higher prices for the sameproducts. This bill recognizes that competition in the global marketplace can work to lowerprescription drug costs. If lower cost pharmaceuticals are made available to Americans, drugcompanies will be forced to re-think their pricing strategy and won't be able to gouge consumersin the United States.Q: What mechanisms does the bill propose to guarantee safety?A: The bill would allow importation of qualified drugs only from registered exporters, whoseactions will be held accountable in U.S. federal courts.Registered exporters must have an FDA-approved compliance plan that demonstrates they aremeeting the safety requirements established in the bill or by FDA. Exporters must permit FDAinspectors to be present onsite on a continuous day-to-day basis and FDA is required to haveassigned inspectors to that exporter. FDA will conduct day-to-day onsite monitoring of theexporter at the place of business for the exporter including any warehouses owned or operated bythe exporter and FDA will have access to inspect the exporters records to ensure compliance.Only where an exporter has demonstrated a track record of compliance will FDA be permitted toperform periodic inspections. The FDA must verify the chain of custody for each qualifying drugfrom the manufacturer of the drug to the exporter.Only licensed pharmacists at the registered exporter will be allowed to dispense prescriptionswith a valid U.S. prescription from a U.S. physician. Commercial shipments can only bereceived and resold by licensed pharmacists. Unauthorized imports would be treated ascontraband and would be seized and destroyed upon entry without notice. Under the bill, anexporter's registration would automatically be suspended for any attempted entry of non-qualifiedor unsafe drugs and these exporters can be barred from seeking reinstatement in the future. Thebill would allow for importation first from Canada in order to test the safety of the system anddetermine whether additional controls are needed before expansion to additional counties.Q: How does the bill prevent drug manufacturers from gaming the system?A: Drug manufacturers that take any action, directly or indirectly, to prevent authorizedimportation will see a loss of their tax deduction for advertising expenses. Drug manufacturersthat do not take action, directly or indirectly, to prevent importation will see a 20 percent increasein their research and development tax credit for that year.Overview of Key Elements of the REMEDIES Act of 2004Legalizes reimportation (or importation) of prescription drugs from FDA approved exporters. Tobe approved, registered exporters must agree to meet safety requirements and to permit FDAinspectors on their premises full time to ensure compliance.Creates a "fast-track" regulatory process for FDA to implement the importation system quickly.Importation of qualified prescription drugs from Canada is immediately legalized while the newimportation system is developed and implemented by FDA.Under the new system, individuals, pharmacies, and drug wholesalers are permitted to legallyimport prescription drugs from registered foreign exporters: 041b061a72


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