The Biden administration is facing increasing pressure from states to allow them to import drugs from Canada to help lower prescription drug costs.
President Joe Biden has endorsed the approach, but his administration has yet to green light a state plan.
“The states have done the work, and the only thing holding them back is the Biden administration,” said Jane Horvath, a health policy consultant who has worked with states on import plans.
Health and Human Services Secretary Xavier Becerra told KHN on Dec. 5 that the Biden administration has received applications for drug import programs from Colorado and other states. But he did not promise that the FDA would rule on any application in 2023.
Asked what his message to the states was, he said: “Sign up and apply, and we’ll see if you can complete the process.”
Buyers in the United States pay the highest prices in the world for brand-name pharmaceuticals. Medicines tend to be less expensive in neighboring Canada, where the government control prices.
Under the presidency of Donald Trump, the US government declared that the importation of medicines from Canada could be done safely, meeting a condition detailed in a Federal Drug Import Act of 2003. The Trump administration finalized the rules in September 2020 for states to apply.
During his White House campaign, Biden said he would allow consumers to import prescription drugs from other countries if the federal government certified those drugs as safe.
After Biden took office in 2021, he directed the FDA to work with states to import prescription drugs from Canada. in a speech last year on how he was going to lower drug prices, he cited Colorado estimates of how much money people in the state could save through importation.
Despite the administration’s public show of support, early applicants have been frustrated by the FDA’s inaction.
In August, nearly two years after submitting his drug proposal, Florida sued the federal government, accusing the Biden administration of walking slowly in its review. The federal government denied the accusation. Florida Gov. Ron DeSantis, a possible 2024 Republican presidential candidate, has 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 fill dozens of gaps in its plan. The letter asked if the state wanted to withdraw its application and file another.
in a december court fileFlorida said that “suddenly conjuring up so many alleged flaws” in its proposal was another “stalemate tactic” by the government.
New Hampshire Department of Health and Human Services spokesman Jake Leon said New Hampshire’s proposal It was rejected because it did not identify a Canadian wholesaler who would supply the drugs. He said the FDA told the state he could reapply when he found one.
New Mexico is still in talks with the FDA, said David Morgan, a spokesman for the state Department of Health.
Other states have shown interest in importing but have yet to seek federal approval.
The pharmaceutical industry, fearful that a government-organized import program could hurt its profits, opposes the strategy and has argued that it would circumvent controls that keep drugs safe in the United States.
The Pharmaceutical Research and Manufacturers of America, the pharmaceutical industry lobby group known as PhRMA, sued the federal government in 2020 to block the importation of drugs. That lawsuit is still pending. The Biden administration has argued in court that the lawsuit is invalid because it is unclear when, if ever, the administration would approve a state’s import plan.
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Many brand name drugs sold in the US are already made abroad. Additionally, millions of Americans have purchased lower-priced medications 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 65% discount on the cost of dozens of drugs, including drugs for diabetes, asthma and cancer.
Kim Bimestefer, executive director of the Colorado Department of Health Care Policy and Financing, told KHN that the state wants to disrupt the current system of drug pricing where manufacturers can charge as much as the market allows. The FDA told state officials it would take six months for the agency to review her 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 based in Boise, Idaho. The drugs would be tested by an Ohio laboratory before being shipped to pharmacies in Colorado and then sold to residents and employers.
Colorado will add security checks for drugs brought in from Canada that go beyond those sold in the United States, Bimestefer said. “We are very confident in their quality and are optimistic about the savings,” he said of the Canadian drugs.
Colorado’s request said the state’s import strategy faces not only resistance from drugmakers, but also concerns from pharmacies and the Canadian government.
Canadian officials have opposed the US import plans because they fear the efforts could lead to a shortage of drugs in Canada. However, Bimestefer said Colorado would bring in drugs only if there is an ample supply for both countries.
The Colorado Business Group on Health, which includes large employers, strongly favors importing but realizes that the Biden administration is under pressure from groups that benefit from the status quo, said Robert Smith, executive director of the coalition. He called the patient safety concerns a “red herring.”
“The only thing we know about health care is that it is driven by economic interests,” he said.
KHN (Kaiser Health News) is a national newsroom that produces detailed journalism on health issues. Along with Policy Analysis and Polling, KHN is one of the top three operating programs in KFF (Kaiser Family Foundation). KFF is an endowed non-profit organization that provides information on health issues to the nation.