Colorado is at odds with the feds over importing prescription drugs, documents show

Colorado’s attempts to import lower-priced prescription drugs from Canada appear to have hit a major roadblock, according to state documents.

Late last month, Colorado submitted an amended application to the federal government for the program, which lawmakers established in 2019.

We’re one step closer to launching our importation drug program, Gov. Jared Polis, who has championed the program as part of his agenda to lower health care costs, said in a statement that accompany the announcement.

But the sometimes tense back-and-forth correspondence between state and federal officials that was included as an appendix to the states’ 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 running. And it also raises questions about whether federal approval will matter if Colorado can’t get Canadian drugmakers and suppliers to work with it.

The Colorados program would use a chain of importers and exporters to bring prescription drugs from Canada to sell at lower prices to pharmacies in Colorado. These are the same drugs now available in the United States, but often sold at much lower prices in Canada.

Here’s the rub, though: In letters and phone calls, officials from the Department of Health Policy and Financing told the FDA that all Canadian drug wholesalers have provisions in their contracts with manufacturers that expressly prohibit the export of its products to the USA.

According to the minutes of a June teleconference meeting between the state and the FDA: Canada’s wholesalers are not willing to put their businesses at risk by selling without manufacturers’ permission. None of the manufacturers have accepted these proposals from Colorado so far.

The correspondence was first reported by KFF Health News, which has been tracking state efforts across the country to establish drug importation programs in order to lower prescription drug costs for their residents.

In a statement to the outlet, HCPF Executive Director Kim Bimestefer said: “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 best to navigate drug purchases.

A spokesperson for HCPF told The Sun he had nothing to add beyond the statement.

22 drug manufacturers declined to participate or did not respond

HCPF officials included in their correspondence with the FDA a list of 23 drug manufacturers they had contacted. Of these, 22 refused to participate in the states’ importation program or did not respond to multiple requests. A request appears as pending.

The state has also been shut out from working with Canadian wholesalers. The wholesale market north of the border is dominated by US giant McKesson, which controls 80% of the market in Canada, according to the state.

Colorado was unable to find someone at McKesson who would speak with them, according to the minutes of the June meeting.

Photo illustration by Mika Baumeister on Unsplash

Instead, the state has tried to work with smaller wholesalers, who expressed concerns about violating their contracts with manufacturers and also about the impact an importation program would have on the country’s drug supply chain. canada

This puts Colorado in a real bind because the FDA wants to see more details before approving the Colorado program. But Colorado officials say they can’t flesh out those details without first getting the FDA’s support.

We believe there is a fundamental disconnect between the (FDA) rule and what is practically required to secure the Canadian drug supply, Bimestefer wrote in a letter to the feds in May.

It has become clear that potential partners will be more interested in committing to participate once our program has been approved by the FDA, Bimestefer wrote in a separate letter last March.

The FDA has so far approved an application for status for a drug importation program. But that state, Florida, has yet to begin importing drugs and still has hurdles to do so—for example, it must submit a pre-importation application to the FDA for each drug it intends to import.

What the way forward for the Colorado program is is unclear. Colorado’s communication with the FDA over the past year has been tense and spotty at times, as shown in the minutes of the June meeting. The minutes, which were drafted by the FDA, contain numerous instances in which Colorado officials objected to how FDA officials characterized the discussion.

At one point near the conclusion of the meeting, the minutes read: FDA confirmed that concerns were adequately addressed. A memo from Colorado officials says: Colorado disagrees. We do not believe that our concerns about sourcing and the lack of consideration of market reality rules in the context of import programs have been adequately addressed.

Colorado officials questioned the FDA’s power to penalize companies that won’t work with state import programs. The FDA did not respond with a clear answer, according to the minutes of the meeting, and suggested that it is not the only agency that may have regulatory authority in this context.

As the program approaches its fifth anniversary, Colorado officials still don’t know how long it will take for the FDA to review its latest application and whether the program will receive approval. At the end of the minutes of the June meeting, FDA placed a section heading: Decisions (agreements) reached.

Under this, the agency wrote: There are no decisions.

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