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Posted by Menris on 2022-10-15

To avoid recreating the unregulated circumstances that occurred in the early s, the Affordable and Safe Prescription Drug Importation Act includes conditions that would only allow products with the same link ingredient, route of administration and strength as drugs approved in the US to be purchased from a Canadian seller certified by the US Food and Drug Administration FDA.

Sellers would need to receive a valid prescription before supplying drugs to individuals. They would also have to certify that their physical premises, data-reporting procedures and licences are in compliance with all applicable Canadian laws and regulations, and have policies to monitor drugs from canada.

Sellers would have to pay a fee to fund the administration and enforcement of the program. Access to lower-price drugs would improve the well-being of Americans without health insurance. However, the act is an impractical way to address the drug-pricing problem in the US for several reasons. First and foremost, drug manufacturers allot sales to a country by assessing the number of people who will take the drug each year based on past practice and a reasonable estimate of likely increases.

Manufacturers are unlikely to increase manufacturing capacity in Canada or to allocate more drugs to Canada from other countries when they know that the drugs will be redistributed to another market, especially a much larger and more lucrative one. Drugs can be approved for different indications or dosages. For example, olaparib received FDA approval in patients with BRCA -mutated advanced ovarian cancer who have had three or more previous lines of chemotherapy, whereas Health Canada approved the drug for patients with platinum-sensitive relapsed BRCA -mutated high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer that responds to platinum-based chemotherapy.

The differences frequently reflect varying views on drugs from canada risks of specific products. Drugs are also commonly submitted for and receive regulatory approval later in Canada than in the US; 8 olaparib was approved by Health Canada more than 16 months after receiving FDA approval. Third, the FDA lacks the resources needed to oversee a major importation program, as recently stated by four former FDA commissioners in a March letter to Drugs from canada.

The actions of Bernie Sanders, who has led the proposal, President Trump and others may simply be a way of putting pressure on the US to introduce controls for drug pricing or for pharmaceutical companies to make their products more affordable. However, if it is enacted and Canadian wholesalers and pharmacies attempt to supply even a small number of Americans who are currently unable to pay for their drugs, shortages would increase in Canada and cause substantial distress to Canadians.

Canada has a system, albeit a criticized one, for assessing drug values and controlling prices within its public drug plans. The Affordable click here Safe Prescription Drug Importation Act may sound reasonable, but it is a band-aid approach to a deeper problem.

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Prescription drug shortages are frequent in the Canadian health care system. In an attempt to cope with unaffordable drug costs, legislation has been proposed in the United States to allow the importation of prescription drugs from Canada, which has the potential to worsen shortages in Canada.

Politicians in the US should address the issue of unaffordable drugs from canada access directly. No other competing interests were declared. This article has been peer reviewed. Contributors: Nigel Rawson and Louise Binder both contributed substantially to the conception of the work, drafted the article, reviewed it critically for important intellectual content, gave final approval of the version canaxa be published and drugs from canada to be accountable for all aspects of the work.

Nigel S. Author information Copyright and License information Disclaimer. Correspondence to: Nigel Rawson, moc. See the reply cansda Drug importation into the United States: impact on Canada " in volume on page E This article has been cited by other articles in PMC. References 1. Drug shortages Canada.

Ottawa: Drugs from canada Canada; 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 U.

Ddugs an executive order issued JulyPresident 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.

10 FAQs on Prescription Drug Importation | KFF

These FAQs discuss recent efforts related to prescription drug importation, the history of this approach, challenges that previous efforts to carry out importation proposals have faced, online drugstore stakeholder views.

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 Septemberthe Trump Administration issued a final rule and final FDA guidancecreating 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 drugs from canada health and safety and would result in significant cost savings. Soon after the rule was finalized, PhRMA and other parties filed a lawsuit challenging the rule based on safety and other concerns. In Maythe Biden Administration sought to dismiss this lawsuit, arguing that plaintiffs cannot show the final rule or the certification by the HHS Secretary has harmed them.

Many studies have shown drugs from canada people in the United States often pay more for their prescription drugs drugs from canada in other developed countries, including Canada. The PMPRB reviews the prices charged for drugsand if the Board determines the price of a drug is excessive, it can order a patentee to lower the price of a drug, including requiring a monetary payment for the excess revenue earned from the drug.

Currently, the only type of legally imported drugs are those that are: 1 manufactured in foreign FDA-inspected facilities, the subject of an FDA-approved drug application, intended for use by U. The MMA specifies that wholesalers and pharmacists can only import prescription drugs from Canada, not other industrialized countries. The MMA also authorizes the Drugs from canada 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.

According to drugs from canada HHS taskforce report on drug importation issued in Decemberthe drug distribution network for prescription drugs in the U. Importation, according to the taskforce report, would create an opening in this closed system that would increase the opportunity for counterfeit, substandard, or unapproved products to enter the supply chain, introducing additional risks to American consumers.

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The report also noted some potential risks and challenges with legalizing importation, including but not limited to: the increasing difficulty of monitoring and ensuring the safety of imported drugs from canada the additional cost and resources needed for ensuring safety, which may reduce potential savings; the possibility that total savings would be significantly less than international price comparisons suggest; and the likelihood that there would be a reduction in research and development of new drugs.

According to a letter to Congress signed by four former FDA commissioners :. It could lead to a host of unintended consequences and undesirable effects, including serious harm drugs from canada from the use of adulterated, substandard, or counterfeit drugs. It could also undermine American confidence in what has proven to be a highly successful system for assuring drug safety. In Septemberthe Trump Administration issued a final rule and final FDA guidance for the importation of prescription drugs from canada.

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 Implementation Programs or SIPs, for importation of prescription drugs from Canada only.

In order for a proposal to be approved by HHS, a SIP sponsor would need to specify: just click for source drugs it seeks to import; the foreign seller in Canada that would purchase the drug directly from its manufacturer; the importer in the U.

SIPs would initially be authorized for 2-year periods with the possibility of 2-year extensions. This pathway would highlight an opportunity for manufacturers to use importation to offer lower-cost versions of their drugs from canada. 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.

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 insulininfused drugs, intravenously injected drugs, and inhaled drugs during surgery.

Furthermore, drugs that are subject to risk evaluation and mitigation strategies REMSwhich 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. These drugs must also currently be marketed in the U.

The potential cost savings from the final rule are unknown. The final regulatory analysis noted that responses by other stakeholders, such as Canadian regulatory agencies and drug manufacturers, could impact the potential benefits of this program.

The Trump Administration did not release an estimate of potential savings for importation in the FDA guidance for industry.

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