How To Buy Prescription Drugs From Canada
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The high cost of prescription drugs continues to be a top health priority for the public. Policymakers at the federal and state level are pursuing a range of options to lower drug prices for Americans, one of which would allow for the safe importation of prescription drugs from Canada and other countries, based on evidence showing that people often pay more for medications in the U.S. than elsewhere. In an executive order issued July 2021, President Joe Biden directed the Food and Drug Administration (FDA) to work with states to import prescription drugs from Canada, an approach that was put into place by the previous Administration and has bipartisan support among the general public (Figure 1).
Current law allows for the importation of certain drugs from Canada under defined, limited circumstances, and only if the Secretary of the United States Department of Health and Human Services (HHS) certifies that importation poses no threat to the health and safety of the American public and will result in significant cost savings to the American consumer. In September 2020, the Trump Administration issued a final rule and final FDA guidance, creating two new pathways for the safe importation of drugs from Canada and other countries, and then-HHS Secretary Alex Azar certified that importation of prescription drugs poses no risk to public health and safety and would result in significant cost savings.
Many studies have shown that people in the United States often pay more for their prescription drugs than in other developed countries, including Canada. According to one analysis of a subset of single-source brand-name drugs, Canadian drug prices are about 28% of the price in the United States, while another analysis of a broad range of drugs found that Canadian prices are 46% of those in the United States.
The Medicare Modernization Act of 2003 (MMA) amended the Section 804 importation language that was added by the MEDS Act. The MMA specifies that wholesalers and pharmacists can only import prescription drugs from Canada, not other industrialized countries. The MMA also authorizes the Secretary to terminate such importation programs if they do not meet safety standards or result in a significant reduction in costs for consumers. The MMA also requires the HHS Secretary to issue regulations that would grant waivers to individuals to import drugs for personal use under certain circumstances.
Importation of prescription drugs under conditions set forth first by the MEDS Act, and then by the MMA, could allow wholesalers and pharmacists to obtain FDA-approved drugs at lower prices than are available in the U.S. by purchasing them from foreign sellers, and pass these savings on to U.S. consumers.
In September 2020, the Trump Administration issued a final rule and final FDA guidance for the importation of prescription drugs. The final rule would authorize states, territories and Indian tribes, and in certain future circumstances wholesalers and pharmacists, to implement time-limited importation programs, known as Section 804 Implementation Programs or SIPs, for importation of prescription drugs from Canada only. States, territories, and Indian tribes could submit proposals to the HHS Secretary to manage these SIPs and act as SIP sponsors.
In order for a proposal to be approved by HHS, a SIP sponsor would need to specify: the drugs it seeks to import; the foreign seller in Canada that would purchase the drug directly from its manufacturer; the importer in the U.S. that would buy the drug directly from the foreign seller in Canada; the re-labeler or re-packager of the drug itself that would ensure the drug meets all labeling requirements in the U.S.; the qualifying lab that would conduct testing of the drug for authenticity and degradation; and steps that would be taken by the SIP to ensure the supply chain is secure. SIPs would initially be authorized for 2-year periods with the possibility of 2-year extensions.
Under the final rule, which allows states and other entities to facilitate importation of drugs from Canada, only drugs that are currently marketed in the U.S. would be eligible for importation. As under current law, certain types of drugs are excluded from the definition of a prescription drug eligible for importation including: controlled substances, biological products (including insulin), infused drugs, intravenously injected drugs, and inhaled drugs during surgery. Furthermore, drugs that are subject to risk evaluation and mitigation strategies (REMS), which are high-risk products with serious safety concerns, such as opioids, are not eligible for importation.
Under the final FDA guidance, which allows manufacturers to import drugs to the U.S. that were manufactured and intended for sale in other countries (not limited to Canada), prescription drugs, including biological products excluded under the final rule, could be imported and made available to patients. These drugs must also currently be marketed in the U.S. to be eligible.
In most circumstances, it is illegal for individuals to import FDA-approved drugs from other countries for personal use. However, based on changes enacted by the MMA, personal importation of prescription drugs that have not been approved by the FDA for use in the U.S. is permitted on a case-by-case basis. Under this statutory authority, FDA has put out guidance that lays out certain circumstances where importation of non-FDA approved drugs for personal use might be allowed. For example, personal importation is generally allowed if the treatment is for a serious condition, there is no effective treatment available in the U.S., and there is no commercialization of the drug for U.S. residents. Typically, only a three-month supply is allowed, and individuals most confirm in writing that the drug is for personal use and provide information about the physician responsible for their treatment.
Many stakeholders have expressed reservations about the feasibility of the current importation plans. Prime Minister Trudeau stated that ensuring the safe and adequate supply of prescription drugs for Canadians is his first priority. However, he also said the Canadian government will take into account the actions of the United States and may be able to provide help to the US and other countries. The Government of Canada stated that it would be unable to meet the needs of the U.S. market without impacting access to medications for Canadians. The Canadian government also expressed concern that this policy would create drug shortages in Canada, and issued an order in November 2020 prohibiting the distribution of drugs that could cause or exacerbate a shortage.
Grassley said his legislation reflects consumer demand for the lower-priced pharmaceuticals available in Canada and responds to the fact that the U.S. Food and Drug Administration (FDA) has declined to take action that could lead to certification of prescription drugs from Canada.
\"Free trade principles argue for allowing importation of drugs from Canada and other countries as long as those drugs are safe,\" Grassley said. \"The FDA has been unresponsive for years, and U.S. consumers have been going around the FDA. Congress needs to take action to make sure that prescription drug imports are both safe and available to U.S. consumers.\"
The new proposal, which Grassley named the Reliable Entry for Medicines at Everyday Discounts through Importation with Effective Safeguards Act of 2004 (S.2307), or the REMEDIES Act, would immediately open the door for U.S. consumers to buy prescription drugs from Canadian pharmacies while the FDA gets a new drug importation system up and running. The bill shuts down rogue operators and requires the FDA to establish a new system within 90 days. The new system would allow individuals, pharmacies and drug wholesalers to buy qualified drugs for import to the United States from foreign exporters who register with the FDA.
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 offered by Sen. Jim Jeffords of Vermont. Grassley supported the Jeffords amendment. Grassley voted a second time for reimportation of prescription drugs from Canada in July 2002, on an amendment offered by Sen. Byron Dorgan of North Dakota. Grassley voted for another Dorgan amendment when it was offered in June 2003. This legislation became part of the Senate bill to add a prescription drug benefit to Medicare, but it was eliminated in the final conference report on the bill.
Q: What are the goals of the legislationA: The legislation has two objectives. First, it would put an immediate end to the unregulated and unsafe situation with drug imports that exists today. Second, the legislation would provide the Food and Drug Administration (FDA) with the resources and authority to ensure the safety of imported drugs.Q: How does the bill workA: Current law prohibits the importation of prescription drugs until the Secretary of Health and Human Services (HHS) certifies that importation can be done safely. Using current resources and 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 prescriptions from Canadian pharmacies on an interim basis while FDA gets the new drug importation system up and running.
Under the bill, the FDA is required to issue final regulations for the new system within 90 days of enactment. Under the new importation system, individuals, pharmacies, and drug wholesalers could purchase qualified drugs for import into the U.S. from foreign exporters that register with the FDA. To obtain a registration, a foreign exporter must demonstrate compliance with safety measures, must submit to jurisdiction of U.S. courts, and take other steps to assure safety of imported drugs. A user fee charged to registered exporters would provide the financing needed for FDA to register and oversee foreign drug exporters and ensure the safety of imported drugs. 59ce067264