Concerned about safety?
Are you a Colorado citizen or healthcare professional, such as a pharmacist, who is concerned about the steps Colorado is taking to expose citizens to drugs from outside the secure supply chain? Please reach out to us at firstname.lastname@example.org.
Drug Importation in Colorado: An Overview
On December 5, 2022, Colorado formally submitted its application to the FDA to import medicine from Canada.
Read the contract with Colorado's Canadian seller, AdiraMedica (Contract, Amdt #1, Amdt #2), with Colorado's importer Premier Pharmaceuticals (Contract, Amendment #1, Amendment #2), or their recall supervisor Rocky Mountain Poison and Drug Safety (Contract, Amendment #1) .
In May 2019, the Governor of Colorado signed SB19-005, a bill which creates a "Canadian Prescription Drug Importation Program" in the Department of Health Care Policy and Financing.
How should we evaluate this program?
The program hasn't started yet so there's no way to measure whether it saved money or kept patients safe, both promises made at the time of passage. However, the 2003 Medicare Modernization Act contains requirements for safety requirements built into any such program.
Official actions and statements
- December 2023: Colorado’s Drug Importation Program, Annual Report to the Colorado General Assembly
- March 2023: The FDA responds to Colorado's Proposal
- December 2022: Colorado submits a final application and appendices to the federal government. The Department of Health Care Policy and Financing publishes its annual report on the project.
- August 2022: Colorado’s Drug Importation Program: Frequently Asked Questions August 2022
- December 2021: Legislative Report from the Department of Health Care Policy and Financing on the implementation of the Prescription Drug Importation Program
- January 2021: The Department of Healthcare Policy and Financing publishes the second edition of Reducing Prescription Drug Costs in Colorado: Cost Drivers and Strategies to Address Them and An Invitation to Negotiate
- October 15, 2020: The Department of Healthcare Policy and Financing updates stakeholders: Slides
- September 23, 2020: Department of Health and Human Services Alex Azar certified that Canadian drug importation would pose no additional threats to consumers and would save Americans a significant amount of money on prescription drugs.
- June 10, 2020: The House Committee on Health & Insurance postponed SB20-119, which would have expanded Colorado's importation program beyond Canada, indefinitely.
- March 9, 2020: Colorado releases draft importation proposal and appendices.
- February 13, 2020: Colorado Health and Human Services Committee hearing on SB 119
- January 2020: The Colorado legislature considers SB20-119, which would expand importation from Canada to prescription drug suppliers from other nations.
- May 16, 2019: Colorado SB19-005 is signed into Law
- October 11, 2019: The Department for Healthcare and Public Financing issues RFIs to pharmacies and wholesalers.
- November 2019: Colorado's Department of Health Care Policy & Financing held webinars to engage stakeholders: Slides
Background / resources
Learn more about
- The Drug Importation Debate
- Fake Medicine in Colorado
- The Importance of U.S. Closed Drug Supply Chain
Op-eds from the Experts
In this analysis, which was published in Lexology on October 13, 2020, three global regulatory experts examine barriers to drug importation.
In this editorial, which was published in WBUR’s Cognoscenti on September 2, 2020, writer Sarah Ruth Bates explains why Canadian drug importation is too expensive and elaborate a solution to be effective.
In this August 14, 2020 editorial, Best Medicines Coalition chair John Adams explains why Canadian importation will not lower U.S. medicine prices—and why the “concept of cheap drugs from Canada has never been anything more than a political hallucination.”
This editorial by Peter J. Pitts was published in The Times Weekly on March 3, 2020. Mr. Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner. Keep Canadian drugs out of U.S. medicine cabinets The Trump administration recently proposed two rules that would allow states, pharmacies,…
In this editorial in The Globe and Mail, Ujjal Dosanjh, formerly a federal minister of health and a premier of British Columbia, explains that drug manufacturers have no incentive to sell Canadian provinces more medicine to fill the needs of U.S. residents. Importation will lead to drug shortages in Canada and counterfeit drug trafficking to the U.S.
This editorial by David C. Rosenbaum and Dara Jospé was published in the Financial Post on January 16, 2020. Rosenbaum is a partner of the law firm Fasken. Jospé is an associate for the same company.
This editorial by Dr. Kristina M. L. Acri née Lybecker was published in IP Watchdog on January 2, 2020. Dr. Acri is an Associate Professor of Economics at Colorado College in Colorado Springs, and Chair of the Department of Economics and Business.
This editorial by Dr. Kenneth E. Thorpe was published in Town Hall on October 8, 2019. Dr. Thorpe is a professor of health policy at Emory University and chairman of the Partnership to Fight Chronic Disease.
This editorial by C. Michael White was published in The Conversation on September 27, 2019. White is a professor and head of the Department of Pharmacy Practice for the University of Connecticut.
This editorial by Peter J. Pitts was published in The Washington Times on September 11, 2019. Mr. Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.