The Biden administration is facing increasing pressure on some states to let them import drugs from Canada to reduce prescription drug costs.
Colorado on Dec. 5 became at least the fourth state to seek federal permission to use the strategy, following Florida, New Hampshire and New Mexico.
In August, Florida’s Agency for Health Care Administration filed a lawsuit against the Food and Drug Administration, saying the agency had “dragged its feet” over the state’s proposal to import drugs from Canada. .
President Joe Biden has endorsed the approach, but his administration has yet to greenlight a statewide plan.
“States have done the job, and the only thing holding them back is the Biden administration,” said Jane Horvath, a health policy consultant who has worked with states on plans for import.
Health and Human Services Secretary Xavier Becerra told KHN on Dec. 5 that the Biden administration welcomes applications for drug import programs from Colorado and other states. But he would not commit to the FDA deciding on any application in 2023.
When asked what his message to the states was, he replied, “Sign up and submit an application, and we’ll review and see if you’re able to get through the process.”
Buyers in the United States pay some of the highest prices in the world for brand name pharmaceuticals. Drugs are generally cheaper in neighboring Canada, where the government controls prices.
Under President Donald Trump, the US government has declared that importing drugs from Canada can be done safely – by meeting a condition set out in a 2003 federal drug importation law. The Trump administration finalized the rules in September 2020 for states to apply.
During his campaign for the White House, Biden said he would allow consumers to import prescription drugs from other countries if the federal government certified those drugs to be safe.
After Biden took office in 2021, he ordered the FDA to work with states to import prescription drugs from Canada. In a speech last year about how he would reduce drug prices, he cited Colorado estimates of how much money the state’s residents could save by importing.
Despite public support from the administration, early applicants were frustrated by the FDA’s inaction.
Florida August’s lawsuit came nearly two years after her drug proposal was submitted. Gov. Ron DeSantis, a potential Republican candidate for president for 2024, defended the state’s effort.
In November, about three months after Florida’s lawsuit, the FDA sent Florida a 15-page letter asking it to close dozens of gaps in its plan. The letter asked if the state wished to withdraw its claim and submit another.
In a December court filing, Florida said the “sudden evocation of so many supposed flaws” in its proposal was another “blocking tactic” by the government.
New Hampshire Department of Health and Human Services spokesman Jake Leon said New Hampshire’s proposal was rejected because it did not identify a Canadian wholesaler who would supply the drugs. He said the FDA told the state it could reapply when it finds one.
New Mexico remains in discussions with the FDA, said David Morgan, spokesman for the state health department.
Other states have expressed interest in importing, but have not yet sought federal approval.
The pharmaceutical industry, fearing that a government-organized import program will eat away at its profits, opposes the strategy and has argued that it would circumvent controls that keep drugs safe in the United States.
Pharmaceutical Research and Manufacturers of America, the pharmaceutical industry lobby known as PhRMA, sued the federal government in 2020 to block the importation of drugs. This trial is still pending. The Biden administration argued in court that the lawsuit was invalid because it’s unclear when, if at all, the administration would approve a state’s import plan.
Many brand name drugs sold in the United States are already manufactured overseas. Additionally, millions of Americans have purchased drugs at low prices in Canada and abroad through online pharmacies and by visiting other countries.
Colorado officials said their proposal aims to save residents and employers an average of 65% on the cost of dozens of drugs, including drugs for diabetes, asthma and cancer.
Kim Bimestefer, executive director of Colorado’s Department of Health Care Policy and Financing, told KHN the state wants to disrupt the current drug pricing system in which manufacturers can charge as much as the market will bear. The FDA told state officials it would take the agency six months to review its proposal, she said.
Colorado’s proposed plan would use a wholesaler in Ontario, Canada, to ship drugs across the border in Buffalo, New York, to an importer headquartered in Boise, Idaho. The drugs would be tested by an Ohio lab before being sent to pharmacies in Colorado and then sold to residents and employers.
Colorado will add safety checks for drugs imported from Canada that will go beyond those for drugs sold in the United States, Bimestefer said. “We are very confident in their quality and optimistic about the savings,” she said of the Canadian drugs.
Colorado’s request indicates that the state’s import strategy is facing not only resistance from drugmakers, but also concerns from pharmacies and the Canadian government.
Canadian officials have opposed U.S. import plans because they fear such efforts could lead to drug shortages in Canada. However, Bimestefer said Colorado would only import drugs if there were sufficient supplies for both countries.
The Colorado Business Group on Health, which includes large employers, is strongly pro-import but realizes the Biden administration is under pressure from groups that profit from the status quo, said Robert Smith, executive director of the coalition. He called concerns about patient safety a “red herring.”
“The only thing we know about health care is that it is driven by personal economic interests,” he said.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism on health issues. Along with policy analysis and polls, KHN is one of the three main operating programs of the KFF (Kaiser Family Foundation). KFF is an endowed non-profit organization providing information on health issues to the nation.
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