Let’s say you take a daily dose of a really common medication — maybe Lipitor, at 10mg a pop.
If you walk into a Denver-area pharmacy and pay out of pocket for the brand-name version, you are looking at around $1,000 for a 90-day supply, according to prices tracked at GoodRX. That comes out to more than $11 a pill.
But, if you happen to be in Canada and wander into a pharmacy there, you might be looking at paying only $2 or $3 a pill for the exact same medicine. There’s a catch, though: If you buy the drug in Canada and bring it back into the United States, you’d be breaking the law.
This well-known prescription predicament is why Colorado and a number of other U.S. states are developing programs to import drugs legally from Canada — and possibly other countries — in the hopes of reducing pill prices here. But it’s been a slow process.
After a burst of momentum during the Trump administration, the federal Food and Drug Administration is moving at a more leisurely pace in the Biden administration. That has left states like Colorado without key federal guidance on whether and when their plans will be approved.
But Colorado and other would-be drug-importing states just got a boost, thanks to an obscure bill making its way through Congress. The bill is called the FDA Safety and Landmark Advancements Act, or FDASLA, pronounced fuh-DAZZ-luh. It continues federal regulation of the pharmaceutical industry.
Because of its necessary purpose, the bill is generally seen as must-pass legislation. That means it is also an attractive place to attach amendments that do more than just dictate the rules that the drug industry must follow — and that is where the cheaper Canadian drugs come in.
During a markup hearing on Tuesday, members of the U.S. Senate Health, Education, Labor and Pensions Committee, including Colorado Sen. John Hickenlooper, added an amendment requiring the FDA to develop rules for importing drugs from Canada. Though the amendment essentially mimics existing FDA rules created in 2020, as well as recently released guidance, it would write those rules into law, meaning the FDA couldn’t waffle or back out on them. It’s essentially a kick in the pants to the FDA.
The plan would allow states to build their own programs, like Colorado is doing, then apply for federal approval. It would also require the FDA to legalize personal importation — people going to Canada and bringing drugs back for themselves.
“This policy is a meaningful change that will lower costs for our patients and families,” Sen. Patty Murray, a Democrat from Washington who is the committee’s chair, said during the hearing.
Concerns over safety
That’s not how everyone sees it, though, including the drug industry. In the days leading up to the hearing, the pharmaceutical lobby raised concerns about the safety of drug importation, questioning how well programs would be able to track exactly where the drugs they bring in are coming from.
Yes, the bottle may say Lipitor, but how do you know that it is? How do you know where that Canadian exporter sourced it from? Who’s going to check to make sure patients aren’t receiving fake or tainted pills?
“Drugs that enter the United States through drug importation schemes would circumvent FDA’s review and approval of our medicine supply,” Priscilla VanderVeer, the vice president of public policy at the pharmaceutical industry group PhRMA, said in a statement after the bill passed committee. “[A]s a result, counterfeit, substandard or diverted, repackaged and adulterated drugs would be more likely to enter the United States with life-threatening consequences.”
PhRMA even raised the specter of the fentanyl epidemic, questioning whether the U.S. would be able to adequately guard against fentanyl-laced pills from shady sources entering the country posing as officially procured pharmaceuticals.
Murray said the bill lays out several safeguards the FDA must put in place in coming up with its importation plans, as well as documentation that must be kept about the drugs’ journeys through the supply chain.
Bipartisan support — to an extent
The amendment was added to the regulatory bill as part of what is known as a “manager’s package” — a collection of pre-negotiated and widely agreed upon amendments that gets tacked onto a bill without much debate. The committee passed the package by unanimous consent.
But the committee also turned away an effort to create a more expansive importation program, fearing stiffer industry opposition and potentially less support among their fellow lawmakers on an issue that can scramble party lines.
During the meeting, Sen. Bernie Sanders, an independent from Vermont, proposed an amendment that would have required the FDA to allow importation from Canada and the United Kingdom, plus more countries after a couple of years. The amendment got support from Sen. Rand Paul, a Republican from Kentucky, as well as several other conservatives.
“This is a policy that unites many on both sides of the aisle, the outrage over the high price for medication,” Paul said.
But the committee ultimately voted to table the amendment — with Hickenlooper among those wanting to do so. By pushing importation harder, some committee members worried about losing the whole bill on the Senate floor, a nod to how fiercely the pharmaceutical industry would likely fight broader importation efforts.
“Let me just say to my colleagues: If you want to kill this bill, do importation,” said Sen. Richard Burr, a North Carolina Republican who is the GOP’s ranking member on the committee.
Congress is running out of time to pass the legislation because the existing regulations on the pharmaceutical industry expire in September. The House has already passed its version of the reauthorization measure.
Colorado, meanwhile, continues to work to set up its importation program. The state hopes to have contracts in place with a Canadian wholesaler and a U.S. importer by the end of summer.
Even once those are in place and if the FDA approves the state’s program, it is still unclear what Canada will do. For years, the Canadian government has said it will not allow its nation’s drug supply to be threatened by large-scale exportation to the United States.