Colorado Officials Blame Biden Administration and Drugmakers for Delaying Canadian Imports
Colorado officials are pointing fingers at both the Biden administration and drug manufacturers, claiming that their plan to import cheaper medicines from Canada has been hindered by opposition and inaction.
According to a report prepared by Colorado's Department of Health Care Policy & Financing for the state legislature, the officials approached 23 drugmakers over the past year regarding an importation program, but only four were willing to discuss the proposal, and none expressed interest in participating.
READ: December 1, 2024 Colorado General Assembly Report
The report states, "Generally, the challenges that remain are outside state authority and rely on action by FDA and/or drug manufacturers."
Lawmakers from both parties, at the state and national levels, have long sought to legalize importing drugs from Canada. In 2020, the Trump administration opened the door to Canadian drug imports, but since then, only a few states have filed applications with the Food and Drug Administration (FDA) to establish importation programs. However, the FDA has yet to make a ruling on any of these applications.
Colorado submitted its application in December 2022, while Florida, which applied in 2020, has been waiting for nearly three years for a decision from the Biden administration on its importation plan. The FDA has stated that it has not acted on these applications because it has not determined if they would provide significant cost savings to consumers without posing risks to public health.
READ: The FDA’s Initial Response To Colorado’s Application
Consumers in the United States pay some of the highest prices worldwide for brand-name pharmaceuticals, while drugs are generally less expensive in Canada due to government price controls.
The Trump administration had declared that importing drugs from Canada could be done safely, satisfying a condition outlined in a 2003 law. However, Colorado officials noted another hurdle: the rule did not account for the fact that states would have to negotiate directly with drug manufacturers who oppose selling their brand-name drugs in the United States at Canadian prices.
The Colorado report stated, "As the federal Final Rule did not contemplate the need for this negotiation step, we have urged the FDA to release further guidance regarding how states can operationalize the program with this in mind, but to date, no guidance has been released."
While the Biden administration has not revoked or revised the importation rule, it has not shown substantial support for the idea either. Health and Human Services Secretary Xavier Becerra stated last December that he would not commit to the FDA ruling on any state application in 2023.
During his presidential campaign, Joe Biden voiced support for allowing the importation of drugs certified as safe by the government.
In 2021, he ordered the FDA to collaborate with states for prescription drug importation from Canada. However, the FDA responded to Colorado's application by requesting more information and a smaller list of drugs to target, aiming to establish that importation would result in cost savings.
Colorado plans to submit an updated application early next year, while the FDA may have already ruled on Florida's application by then.
Colorado State Senator Sonya Jaquez Lewis, a Democrat, pharmacist, and advocate for drug importation, criticized drug manufacturers, stating in response to the report, "They will do anything to protect their golden goose that is United States consumers and patients who pay the largest amount for drugs in the world." She called upon the White House and Congress to compel drugmakers to negotiate with states for the implementation of importation programs.
Another hurdle comes from the FDA's rule, which prohibits states from buying drugs directly from secondary drug wholesalers. Instead, they must purchase medications directly from manufacturers.