Dody Tsiantar was on a visit to Greece when she ran out of her prescription diabetes medication. Fortunately, the local pharmacy had the same medication in stock and she bought a one-month supply for about 30 Euros (about $33) – a price that for her was “no big deal.”
But after returning home to Florida, she was shocked when the pharmacist rang up her medication.
“For two months’ worth, they wanted me to pay $320,” she said in a phone interview. That’s almost five times what she paid in Greece. “There’s such a discrepancy. And it doesn’t make sense.”
Because of a clerical error with her insurer, Medicare, Tsiantar had to pay full price for a period.
In Tsiantar’s state, Florida, Gov. Ron DeSantis is pushing a new strategy to get drug prices under control by importing them from abroad, at a much lower price than Americans are currently forced to pay. And other states are hoping to follow suit.
People all over the country are struggling to afford their prescription drugs. Researchers found that between 2014 and 2022, prescription drug prices went up by 35%, faster than all other healthcare costs. In 2022 alone, the prices of more than 1,200 medications had their prices increase by an average of 32%, blowing past the 8.5% inflation rate.
One in four skip doses
Insured and uninsured Americans are feeling the pain. One in four say they have had to skip doses of medication due to cost, according to one survey.
In most other countries, including Canada, drug companies charge less money for the same medications sold in the U.S. In response to the crisis, then-president Trump’s administration issued new guidance in 2020 that opened the door for states to import drugs from abroad – as long as the Food and Drug Administration found it was safe.
And some states, including Florida. states are taking the federal government up on their offer, hoping to save patients and taxpayers millions of dollars a year
Colorado became the latest state to pitch their importing plan when it submitted its application to the F.D.A. last month. If the plan is approved, the state will work with Canada to purchase 112 medications and disseminate them to pharmacies through the state’s existing distribution infrastructure, a plan officials say will save patients 65% on average.
No approval from F.D.A.
Since 2020, at least four states have submitted proposals, but despite President Biden’s endorsement of the strategy, none has been approved yet. Gov. DeSantis, whose state submitted its proposal over two years ago, actually sued the F.D.A., accusing the Biden administration of duplicity – saying it supports the proposal but throwing up roadblocks behind closed doors.
“The lack of transparency by the Biden administration during the approval process, and failure to provide records on the importation proposal, is costing Floridians who are facing rising prices across the board due to inflation,” DeSantis said at an August press conference.
In a report from the Florida Daily press release, Ashley Moody, Florida’s attorney general, put it even more bluntly, saying, “Governor DeSantis and I are fighting to lower prescription drug costs, but Washington bureaucrats are blocking our efforts.”
Besides Colorado and Florida, Oklahoma, Utah, Vermont, West Virginia, Vermont, Maine, New Mexico and New Hampshire have introduced legislation or enacted laws allowing licensed wholesalers to import drugs from Canada, indicating that they have future plans to set up a program but have not yet sent formal proposals to the F.D.A.for approval.
Even if the states get the O.K. from Washington, obstacles remain. It turns out that Canada itself would have to be on board – something U.S. states have no control over.
An official memo from 2019 stated that Canada’s government was concerned that the importing arrangement could result in drug shortages for its own residents. “Canada does not support actions that could adversely affect the supply of prescription drugs in Canada and potentially raise costs of prescription drugs for Canadians,” the memo said.
U.S. pharma lobby opposition
The industry’s premier trade group, the Pharmaceutical Research and Manufacturers of America, abbreviated PhRMA, has said it will fight to prevent states from enacting plans to import drugs. The group already sued the federal government in an effort to prevent the 2020 policy that opened the doors to states importing meds. That lawsuit is still pending. Since then, the group has also sought to block specific states from implementing the plan.
PhRMA has said it opposes importing drugs from Canada, mostly because of safety concerns.
“Drugs that enter the United States through drug importation schemes would circumvent FDA’s review and approval of our medicine supply,” Priscilla VanderVeer, a PhRMA representative, said in an official statement.
But advocates of importing say this concern falls flat, mostly because the U.S. already imports at least 40% of the medications and 80% of the active ingredients – and these drugs meet all the FDA’s stringent safety requirements.
“Federal regulation already ensures the safety of foreign manufactured products that ultimately come to the U.S. for consumption,” physician-researchers at the Mayo Clinic in Minnesota wrote in a 2021 article.
Jane Horvath, a health policy expert familiar with states’ legislation, said there is nothing in the proposals to suggest they would bypass F.D.A.policy, mostly because it is illegal and no state plan that goes against federal safety laws would be allowed.
“[State’s applications] would never get approved if they didn’t comply with the regulations,” she said in a phone interview. “These state level, wholesale importation programs require that [drugs] be manufactured in F.D.A.-registered plants, wherever they are in the world,”
Horvath said the law requires even more failsafes. When these drug shipments – already made in U.S. licensed plants – get to a U.S. border or port, they are held until they can be batch-tested by an F.D.A.-certified lab for purity and quality control.
Kaiser Health News reported that millions of Americans a year buy their own medications from Canada, without any oversight on the U.S. side.
Will it actually help anyone?
The other unknown that could doom the proposals is how well or poorly it works in practice. Horvath said that all the red tape involved might make the importing process so costly that it cancels out the savings that comes from actually buying the drugs at a lower price.
“You can make this incredibly difficult and say that you’re trying to allow people to do it, but make it so onerous that ultimately, you don’t save any money,” she said.
But, Horvath said, if the medications make it to Americans’ local pharmacies, it will ultimately save patients money.
“If you’re uninsured, it would definitely make a difference for you,” she said. “Or you’re insured – and you have coinsurance, where a percentage of the cost of the drug is what you have to pay at the pharmacy or you have a drug deductible – getting a drug and a much lower Canadian cost is certainly going to benefit you.”
Horvath said that if one state is successful at reducing drug costs, she expects other states to try the same thing.