Partnership for Safe Medicines Statement on Proposed Regulations to Import Prescription Medicines from Canada
Washington, D.C. (December 18, 2019) – Shabbir Safdar, executive director of the Partnership for Safe Medicines, released the following statement in response to today’s announcement by the Trump Administration and the proposed regulations to allow importation of prescription medicines:
“Citizens of the United States and Canada should be outraged that the Trump Administration has prioritized politics over their own health and safety. There’s only one logical explanation why the Administration chose this week to greenlight a flawed and dangerous policy that Republican and Democratic Administrations alike have rejected – political distraction. The process has been mishandled from day one, which stands in stark contrast to the time and effort that other administrations have put into this issue.”
“It is well-documented that the Canadian drug supply is not nearly large enough to meet the demand of U.S. patients. So even with a fraction of U.S. drugs coming from Canada, life-threatening shortages would become the reality there within mere months.
“We’ve seen time and again that gaps in supply are filled by dangerous counterfeits that can end up in the hands of patients on both sides of the border – a risk that’s dramatically exacerbated by this importation policy.
“Perhaps most frustrating is that there is no guarantee patients will get financial relief at the pharmacy counter. Multiple states, including Illinois, Minnesota, and Maine, have attempted to implement drug importation and failed. These schemes have never been able to sustain economic savings that offset their costs, and all of them have had safety lapses.
“This is far worse than a lump of coal in one’s stocking. It’s more like a ticking time bomb that will inevitably result in dire consequences for Americans and Canadians alike. As we assess the proposed rule and draft guidance issued by the U.S. Department of Health and Human Services today, we will continue to vigorously defend the integrity of our drug supply and work to ensure that health and safety always come first.”
Policymaker response to these dangerous proposals
- New Life In Drug Importation | Health AffairsMarch 24, 2023
- Importation of Prescription Drugs Final Rule Questions and Answers Guidance for IndustryMay 2022
- Medication Importation Requires More Study to Ensure Patient Safety, Cautions NABPOctober 2, 2020
- NABP Position Statement on New Federal Importation RulesOctober 1, 2020
- Administration Finalizes Drug Importation Plans, But Legal And Practical Questions Remain | Health AffairsSeptember 25, 2020
- Two Cheers For Our Drug ManufacturersSeptember 25, 2020
- Plan To Allow States To Import Drugs From Canada Doesn't Go Far Enough, Says Maine Senate Leader | Maine PublicSeptember 25, 2020
- HHS to allow for the importation of certain drugs from Canada and other countries | Healthcare Finance NewsSeptember 25, 2020
- Trump Administration Defies 20 Years of FDA Expertise and Guidance in Finalizing Politically Motivated Drug Importation Rule – Partnership for Safe MedicinesSeptember 24, 2020
- Trump Promises Seniors $200 Prescription Drug Gift CertificatesSeptember 24, 2020
- CAHC Statement: FDA Final Rule and Guidance on Importation of Prescription Drugs — Council for Affordable Health CoverageSeptember 25, 2020
- Trump Approves Final Plan to Import Drugs From Canada ‘for a Fraction of the Price’ | Kaiser Health NewsSeptember 24, 2020
- Trump Makes His Final Health Care Play - POLITICOSeptember 25, 2020
- Election Gift for Florida? Trump Poised to Approve Drug Imports From Canada | Kaiser Health NewsSeptember 18, 2020
- Opinion: The U.S. has a Problem with Prescription-drug Prices. Canada Shouldn’t Try to Fix itMarch 2, 2020
- American Pharmacists Association Issues a Call to Action in Opposition to Drug Importation, February 2020"On December 23, 2019, the Food and Drug Administration (FDA) published a proposed rule that, if finalized, would create a program for the legal importation of certain drugs from Canada to the United States. FDA’s drug importation program is NOT a safe way to reduce drug prices, and it puts patients at risk."
- Prescription Drugs Imported from Canada Won't Lower Prices for American Consumers, Experts Say, CBS News, December 20, 2019"...while they applaud the policy's goal, experts say the plan to allow foreign drug imports is unlikely to significantly lower costs in the U.S."
- Importation Scheme Will Jeopardize Patient Health, Do Little to Lower Drug Costs, BIO, December 18, 2019“Patients deserve access to the medicines they need with out-of-pocket costs they can afford. Under no circumstance should we risk patient safety to achieve this goal, yet that’s exactly what this dangerous importation scheme will do."
- National Consumers League Urges Caution Following HHS Drug Importation Announcement, December 20, 2019The NCL's "primary concerns are that this proposed new rule will put the public at greater risk of counterfeit drugs while not clearly passing on any cost savings on to consumer."
- Pharmacy Associations Offer Perspective on Canada Drug Import Proposal, Drug Topics, December 20, 2019American Society of Health-System Pharmacists "has long been opposed to importing drugs from Canada due to safety concerns. 'One of our main concerns with the safety of importation is potentially bypassing safety requirements intended to protect against contaminated or counterfeit medications."”
Resources
Proposed regulations for importation by pharmacists and wholesalers (Pathway #1) or by manufacturers (Pathway #2).
The importation provisions of the 2003 Medicare Modernization Act.
Letter from four previous FDA commissioners appointed by both Democrats and Republicans about why Canadian drug importation won't save money or keep patients safe.
If you would like to express your concerns about the rulemaking, feel free to contact us at editors@safemedicines.org.