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 As we assess the proposed rule and draft guidance issued by the U.S. Department of Health and Human Services today, we will continue to vigorously defend the integrity of our drug supply and work to ensure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.”
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.
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