The Trump administration is opening the door to letting states, pharmacies, and drug companies import medicines that are Food and Drug Administration-approved, but manufactured for Canada and other foreign countries. It's yet another effort by the administration to lower drug prices for Americans: Drugs sold in countries where the government negotiates with pharmaceutical companies, such as Canada and the United Kingdom, tend to be far cheaper than in the United States, where the government is barred from such bargaining, as a Reuters analysis found in 2015.
"This is the next important step in the administration's work to end foreign freeloading and put American patients first," Alex Azar, head of the Department of Health and Human Services (HHS), said in a statement announcing the plan.
Here are five important facts to know about the plan.
Insulin Isn't Covered Under Parts of the Plan
Insulin has become a poster child for America's high drug prices, because its price tag has gone up so steeply in recent years, and millions of Americans with diabetes depend on it. Yet it wouldn't be eligible under one of the two pathways for drug importation that the administration is proposing. Under Pathway 1, large-scale buyers of drugs—such as states, wholesalers, and pharmacies—can submit proposals to the HHS, explaining how they would safely and cheaply import medicines approved by Canada's drug regulator, Health Canada. They couldn't ask to import insulin in this way, however, because insulin is a biologic drug, meaning it's made from a complex biological product, instead of a simpler, stabler chemical. The way that American law is written, biologic drugs can't be imported under something like Pathway 1, an HHS spokesperson explains in an email.
Insulin and other biologics would be open for importation under Pathway 2, which is for drug makers, rather than drug buyers. Pathway 2 lets pharmaceutical companies import versions of FDA-approved drugs that they've made to sell in other countries. These medicines, too, would be cheaper. It remains to be seen whether drug companies will want to take advantage of this pathway. Industry groups oppose drug importation: In a statement on Wednesday, Pharmaceutical Research and Manufacturers of America president Stephen J. Ubl argued that imported drugs could be dangerous.
The Plan Could Take a Long Time to Put Into Action
Speaking of Pathway 1, STAT explains that the importation of drugs probably won't happen for some time: "After the idea goes through regulatory review—which itself could take months, if not years—the Trump administration plan will only be a pilot, and there's little clarity on whether it'll ever be scaled up nationally."
But Several States Already Have Policies Prepared
The FDA has always held that importing foreign drugs is illegal (though the agency doesn't often prosecute the crime). Nevertheless, in the last year, several states have put together drug importation bills, which could go into effect if the HHS approves them. As of May 16th, 2019, Vermont, Florida, and Colorado had signed drug importation plans into law, while several other states either have bills pending, or their bills failed, according to the National Conference of State Legislatures.
President Donald Trump has said he supports Colorado and Florida's bills, the Colorado Sun reports.
Canada May Not Agree to the Plan
If the U.S. starts importing drugs manufactured for its northern neighbor, Canadian officials fear that it'll lead to a drug shortage or higher prices for Canadians, Reuters reported earlier this month.