Colorado submits prescription drug importation proposal to FDA

Colorado’s Department of Health Care Policy & Financing (HCPF) submitted its proposal to import prescription drugs from Canada for FDA approval on Monday. 

 

 

The submission is the first step in implementing the state-administered wholesale importation program, which aims to provide price competition and relieve high prescription drug costs for Coloradans. 

“This exciting step means we are closer to savings for Coloradans as we continue to take bold action to make prescription drugs and health care more affordable. We promised on day one to save people money on health care, and we are getting it done,” Gov. Jared Polis said. “Colorado’s Drug Importation Program is a major piece in our work to lower the cost of prescription drugs, and this final step gets us even closer to making lower health costs a reality for Coloradans. Now all we need is FDA approval and Coloradans will start saving money!” 

Federal estimates project prescription drug cost trends to keep rising with total US prescription drug spending growing 60% from $360.3 billion in 2019 to $576.7 billion in 2027. 

In 2019, Coloradans spent $6.7 billion on prescriptions filled at retail pharmacies and, according to the Colorado Health Institute, one in 10 Coloradans did not fill a prescription due to costs.  

HCPF says the program could result in an average of 65% in savings on targeted import medications. HCPF’s recent analysis estimated the program could save the state $53 to $88 million annually on some 116 identified drugs.

In September, Colorado announced a partnership with AdiraMedica, a Canadian wholesaler, and Premier Pharmaceuticals, a wholesaler based in Idaho that will secure drugs directly from manufacturers and distribute the drugs throughout the state, respectively. 

Rocky Mountain Poison and Drug Safety will provide oversight on drug safety, including managing product recalls and outreach and reporting adverse effects. Already, some 40% of the prescription drugs used in the US are manufactured abroad and considered safe, according to the FDA. 

“Our Importation Program, once approved by the FDA, will bring meaningful savings to Colorado consumers and employers,” said Kim Bimestefer, Executive Director of the Department. “Dozens of commonly used, life-saving drugs can be imported through Canada for pennies on the dollar. As examples, Jardiance, a drug used to treat Type II diabetes or Flovent, an inhaler, are about 80% less expensive through our importation program.”

Colorado is one of several states seeking to implement state-led importation programs after federal policy reforms in 2020 made importation of certain prescription drugs possible. 

The FDA has suggested a 6-month review timeline. Once the proposal is approved, HCPF will initiate stakeholder engagement on the program’s implementation. Officials said if everything moves according to plan, the first tranche of imported drugs could be on shelves in local pharmacies by late 2023.