Weekly Policy Blog: Colorado Drug Importation Program Faces Roadblocks  

Colorado is still working to become the second state, after Florida, to be authorized to import prescription drugs from Canada. The Colorado Department of Health Care Policy & Financing (HCPF) submitted an amended Section 804 Importation Program (SIP) proposal to the FDA. This submission addressed questions asked by the FDA in a request for information (RFI) and was the next step in seeking federal approval to operate Colorado’s Canadian Drug Importation Program. The amended SIP application includes a list of 24 drugs for importation, which was reduced from 112 drugs in an attempt to make the undertaking more practicable. HCPF shared during a March 12 stakeholder meeting that it anticipates the FDA will come back with another RFI within the next 3-6 months and estimates the FDA could approve Colorado’s Importation Program by as early as late 2024. 

PhRMA provides additional context on the realities of importation in this backgrounder: The Dangers of Drug Importation.

In the state’s 2/27 press release, Colorado Governor Jared Polis said, “We know this will help save people money on prescription drugs — upwards of $51 million in the first three years and now we are one step closer to launching our Drug Importation Program.” 

However, a March 19 article from The Colorado Sun sheds light on how “sometimes tense back-and-forth correspondence between state and federal officials that was included as an appendix in the state’s application paints a different picture. It shows Colorado and the federal Food and Drug Administration at odds over how Colorado could get a program approved and off the ground. And it also raises questions about whether federal approval will even matter if Colorado can’t get drugmakers and Canadian suppliers to work with it.” 

Canadian officials have continued to express concerns about and opposition to U.S. states importing drugs from Canada, saying in an official statement, “The Government of Canada is taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need and has been clear in its position: bulk importation will not provide an effective solution to the problem of high drug prices in the U.S.” Going even further, Canada’s Minister of Health Mark Holland has said, “There is no way we will allow any jurisdiction, be it a state or another foreign jurisdiction, to endanger the Canadian drug supply. That is not an appropriate solution to whatever challenges they may be facing. We’re going to do everything in our power to make sure that another country cannot be given the ability to pillage our health system for its own benefit.” 

Colorado BioScience Association maintains that, even if the significant implementation hurdles could be surmounted, importing prescription drugs from Canada would jeopardize patient safety and do little to lower out-of-pocket costs for Coloradans. CBSA will continue to monitor, engage, and advocate on importation both locally and nationally on behalf of the life sciences ecosystem and the patients it serves. 

Categories: CBSA News