Colorado’s General Assembly passed a law in 2019 that allowed the Colorado Department of Health Care Policy and Financing (HCPF) to develop a Canadian prescription drug importation program. In March 2020, Colorado submitted a program proposal and detailed comments in response to the December 2019 federal Health and Human Services (HHS) Notice of Proposed Rulemaking (NPRM)/draft rule.
The HHS final rule went into effect in November 2020, implementing a federal regulatory framework that directs how to develop and operate an Importation Program. In January 2021, HCPF sought vendors for the program and issued an Invitation to Negotiate, seeking vendors for the program. The ITN closed in April 2021 and HCPF started negotiations with supply chain partners and identified program consultants and certifiers to ensure compliant program development. Program partners were announced in August 2022 and on December 5, 2022, HCPF submitted the Section 804 Importation Program (SIP) application to the Food and Drug Administration (FDA) for review and approval. In response to an FDA Request for Information, HCPF amended the SIP application on February 27, 2024, and currently estimates that the Colorado Importation Program will be approved in 2024.
According to a report issued by Colorado in 2023, the state said it was having difficulty with “securing drug supply for the program, drug manufacturer resistance, and regulatory ambiguity.” Additionally, the report states that of twenty-three drug companies, nine companies refused participation in Colorado’s drug importation program and four agreed to meet but said they would not participate in the program. The other ten companies did not respond to requests to meet, despite multiple attempts.
In that report, it was also noted that “[b]ecause drug manufacturers in Canada have contract terms with wholesalers, including any FDA-required foreign seller, that prohibit the exportation of drugs to the U.S., Colorado is unable to secure drug supply absent direct negotiation, and ultimately a contractual agreement, with manufacturers.”
Colorado turned to the FDA for help with the number of refusals, and the FDA said it is not mandatory that the agency help compel manufacturers to sell drugs that are intended for the Canadian market to the United States. Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, said that the state still hopes for the FDA’s help, “While we continue to reach out to manufacturers to ask them to do the right thing for consumers, employers and taxpayers, we are also working with the FDA for additional guidance on how to best navigate sourcing drugs.”
The FDA also reinforced its willingness to “continue to work with states and Indian tribes” to develop their individual importation programs through a statement by FDA spokesperson Jeremy Kahn.
Florida Still Seemingly at a Standstill
For what it’s worth, Florida is still having difficulty in importing drugs from Canada, with Brock Juarez, a spokesperson for the Florida Agency for Health Care Administration, saying, “Our vendor is establishing relationships with drug manufacturers and working on negotiating agreements.”