President Trump wants to let Americans import prescription drugs from Canada, part of his agenda for lowering drug prices. He has eyed several measures to pursue the goal of lower prices, from mandating that drug companies list prices on TV ads (a policy halted by the courts), to tying drug prices in the U.S. to the prices of the same drugs in foreign countries.
The administration’s latest policy would be to enact a program to import drugs, primarily from Canada:
On July 31, Health and Human Services Secretary Alex Azar and acting Commissioner of the Food and Drug Administration Ned Sharpless outlined plans that would allow individual states, pharmacies, or wholesalers to draw up proposals to safely import drugs from Canadian wholesale distributors and then submit their proposals for federal approval.
Not all drugs would be eligible for importation. Biologics, medications created from living organisms, like insulin for example, cannot be imported under existing law.
The proposal vaguely mentions the possibility, though, for that to change. The the second part of the plan says that if the importation plans are adopted, the FDA would be permitted to work with drug manufacturers toward bringing their drugs made in foreign factories to the U.S., which “would potentially include medications like insulin used to treat diabetes.”
Similar ideas have cropped up at the state level:
Most recently, Florida Gov. Ron DeSantis, a Republican, signed a bill in June to allow the Florida Department of Health to buy medication in bulk from U.S. government-approved Canadian wholesalers. In May 2018, Vermont Gov. Phil Scott, also a Republican, signed a similar importation bill.
The HHS proposal announced Wednesday leaves almost all control to state governments, pharmacies and wholesale distributors who write up their own plans. Azar, though, has yet to approve the importation plans already proposed in Florida and Vermont.
Who is in favor of the plan, and why?
Both Republicans and Democrats in Congress have suggested that importing cheaper versions of FDA-approved drugs sold in Canada is the answer to high drug prices. Prescription drugs are generally less than half their price of their equivalents in the U.S., according to an analysis of a basket of drugs conducted by IHS Markit. For example, PharmacyChecker, which verifies the legitimacy of pharmacies overseas, found that the anti-psychotic drug Abilify and the blood thinner Xarelto cost about 87% and 60% less in Canada respectively.
Key Republicans, such as Senate Health, Education, Labor, and Pensions Committee Chairman Lamar Alexander, have backed the administration’s plan. Iowa Sen. Chuck Grassley, another Republican, introduced a bill in January with Minnesota Democratic Sen. Amy Klobuchar to import prescriptions from FDA-vetted Canadian pharmacies.
Yet drug importation is an idea that traditional has found greater favor among Democrats. In February 2017, Sens. Bernie Sanders of Vermont and Cory Booker of New Jersey, both now vying for the Democratic presidential nomination, introduced a bill with Democratic Sen. Bob Casey of Pennsylvania to import drugs from Canada to lower prices. Democratic representatives Elijah Cummings and Lloyd Doggett introduced House versions of the same bill. Sanders has pledged to begin drug importation on his first day in the Oval Office.
The population with the most to gain from drug importation plans is Medicare beneficiaries.
The AARP was quick to support DeSantis when he introduced Florida’s importation plan. Dave Bruns, a spokesman for the Florida AARP, said that too many seniors have to forego medication or cut doses because their life-sustaining medications are unaffordable.
Who opposes drug importation and why?
PhRMA, a trade group for pharmaceutical companies, has long opposed drug importation, saying it would open the floodgates to counterfeit, dangerous medications. Its CEO, Stephen Ubl, called the administration’s proposal “far too dangerous.”
Though HHS and the FDA haven’t said which countries would take part in a tentative plan to import biologics, including insulin, Canada was named as the chief exporter of other drugs to be imported. Canadian drug manufacturers, however, are not rushing to sign an agreement with the FDA.
Azar said he has been in communication with Canada’s health minister, Ginette Petitpas Taylor, about lowering drug prices. Officials in Taylor’s office, however, said the HHS announcement took them by surprise and that Azar didn’t speak specifically about how to supply both countries with FDA-approved medications.
Another big objection is that Canada does not have an unlimited supply of medications. Azar said as much in 2018 when he called drug importation a “gimmick”: “Canada’s drug market is simply too small to bring down prices here.”
Most prescription drugs in Canada are imported, rather than manufactured within the country’s borders, and the government places price ceilings on the brand-name medications brought to the country. Canadian health groups say the country cannot afford to send their own supplies, which are already limited, across the border.
The Canadian Pharmacists Association said Thursday that “the Canadian medicine supply is not equipped to support both Canadian and U.S. consumers, and will make existing drug shortages in Canada even worse, disrupting patients’ access to their medications.”
Though U.S. agencies have not publicly discussed plans after Wednesday’s announcement, the Canadian Pharmacists Association is calling on the Canadian government to formally oppose drug importation proposals and possibly limit drug exports to the U.S.
