Prescription drugs

Senate bills boost importation of prescription drugs from Canada

Let’s say you’re taking a daily dose of a very common drug – maybe Lipitor, at 10mg per pop.

If you walk into a Denver-area pharmacy and pay out of pocket for the brand name version, you’re looking at around $1,000 for a 90-day supply, according to prices tracked at GoodRX. That works out to over $11 a pill.

But, if you happen to be in Canada and walk into a pharmacy there, you might be looking at paying only $2 or $3 a pill for the exact same drug. There is a catch though: if you buy the drug in Canada and bring it back to the United States, you would be breaking the law.

This well-known prescribing situation is why Colorado and a number of other US states are developing programs to legally import drugs from Canada – and possibly other countries – in hopes of reducing pill prices here. But it was a slow process.

After a boost under the Trump administration, the federal Food and Drug Administration is moving at a more leisurely pace under the Biden administration. That has left states like Colorado without key federal guidelines on whether and when their plans will be approved.

But Colorado and other potentially drug-importing states just got a boost, thanks to an arcane bill making its way through Congress. The bill is called the FDA Safety and Landmark Advancements Act, or FDASLA, pronounced fuh-DAZZ-luh. He is pursuing federal regulation of the pharmaceutical industry.

Due to its necessary purpose, the bill is generally regarded as must-have legislation. That means it’s also an attractive place to attach amendments that do more than just dictate the rules the pharmaceutical industry must follow – and that’s where cheaper Canadian drugs come in.

During a markup hearing on Tuesday, members of the U.S. Senate Committee on Health, Education, Labor and Pensions, including Colorado Sen. John Hickenlooper, added an amendment requiring the FDA to develop rules for importing drugs from Canada. Although the amendment essentially mimics existing FDA rules created in 2020, as well as recently released guidelines, it would write those rules into law, meaning the FDA could not dither or backtrack on them. It’s basically a kick in the pants of the FDA.

The plan would allow states to create their own programs, as Colorado does, and then seek federal approval. It would also force the FDA to legalize personal importation — people traveling to Canada and bringing drugs back for themselves.

“This policy is a significant change that will reduce costs for our patients and their families,” said Senator Patty Murray, Democrat of Washington and chair of the committee, during the hearing.

Safety Concerns

Not everyone sees it that way, including the pharmaceutical industry. In the days leading up to the hearing, the pharmaceutical lobby raised concerns about the safety of importing drugs, wondering to what extent the programs would be able to track exactly where the drugs they came from bring.

Yes, the bottle may say Lipitor, but how do you know it is? How do you know where this Canadian exporter sourced it from? Who will check to ensure that patients are not given counterfeit or contaminated pills?

Truvada for PrEP, an HIV antiretroviral drug taken by HIV-negative people in at-risk communities. (Tony Webser, via Creative Commons)

“Drugs entering the United States through drug import programs would bypass FDA review and approval of our drug supply,” said Priscilla VanderVeer, group vice president of public policy. pharmaceutical company PhRMA, in a statement after the bill was passed by the committee. “[A]As 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, wondering if the United States would be able to adequately guard against fentanyl-containing pills from shady sources entering the country masquerading as purchased pharmaceuticals. officially.

Murray said the bill sets out several safeguards the FDA must put in place to make its import plans, as well as the documentation that must be kept on the drugs’ journeys through the supply chain.

Bipartisan support – to some 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, widely accepted amendments that are added to a bill without too much debate. The committee adopted the package unanimously.

But the committee has also hijacked an effort to create a more expansive import agenda, fearing tougher industry opposition and potentially less support among fellow lawmakers on an issue that may blur party lines.

During the meeting, Senator Bernie Sanders, an independent from Vermont, proposed an amendment that would have required the FDA to allow importation from Canada and the United Kingdom, as well as other countries after a few years. The amendment won the support of Senator Rand Paul, a Republican from Kentucky, as well as several other conservatives.

“It’s a policy that unites many on both sides of the aisle, outrage over high drug prices,” Paul said.

But the committee ultimately voted to table the amendment – with Hickenlooper among those willing to do so. By pushing the importation harder, some committee members feared losing the entire bill in the Senate, a nod to how fiercely the pharmaceutical industry would likely fight broader importation efforts.

“Let me say to my colleagues: If you want to kill this bill, import it,” said Sen. Richard Burr, a Republican from North Carolina who is the top GOP member on the committee.

Congress is running out of time to pass the legislation as 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 establish its import program. The state hopes to have contracts with a Canadian wholesaler and an American importer by the end of the summer.

Even with those in place and if the FDA approves the state program, it’s still unclear what Canada will do. For years, the Canadian government has said it will not allow its country’s drug supply to be threatened by large-scale export to the United States.

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Joan J. Dean

The author Joan J. Dean