Instead of being gouged on the prices for old drugs, Americans could import certain meds from Canada if a bipartisan group of senators get their way.
Sens. Amy Klobuchar, D-Minn., Chuck Grassley, R-Iowa, and John McCain, R-Ariz., are pushing President Donald Trump’s new Department of Health and Human Services Secretary, Tom Price, to authorize cheap drug imports under strict circumstances.
Their bill, the Safe and Affordable Drugs from Canada Act, would require the FDA to set up a “personal importation program” to allow individuals to import 90-day supplies of their meds from Canadian pharmacies.
As the senators point out in their letter, a 2003 law allows the FDA to authorize imports in certain circumstances. First, though, the HHS secretary must sign off that they "pose no additional risk to the public's health and safety and would result in a significant reduction in the cost" for consumers."
To qualify for importation, the senators' proposal would require products to be off patent or no longer marketed in the U.S. by the original developer. They'd need to be free of direct competition and to have seen a “significant, unexplained” price hike. The imported product would also need to be produced by a reputable company. The bill additionally calls for fast-track FDA reviews of competing drugs.
On the safety point, pharma's trade group is pushing back. In a statement to FiercePharma, PhRMA pointed to a Drug Enforcement Administration report last year that concluded counterfeit fentanyl from China made its way to the U.S. through Canada and Mexico, worsening the current opioid crisis. Imports “would exacerbate these threats,” a PhRMA spokesperson said.
Imported drugs wouldn’t “be subject to the U.S. Food and Drug Administration’s robust safety requirements, and there would be no way to trace the country of origin for the imported products. Even Canada has said it does not and would not be able to guarantee that U.S. citizens would receive products that are safe, effective and of high quality,” PhRMA’s spokesperson said. “Guaranteeing patient safety is crucial, and we must have policies that ensure patients safely have access to the medicines they need.”
The U.S. senate voted down a Canadian drug importation bill proposed by Sen. Bernie Sanders, I-Vt., earlier this year. Thirteen Democrats voted against the measure and 12 Republicans supported Sanders’ idea. Among the Republicans voting for the measure were McCain and Sen. Ted Cruz, R-Texas, who backed parallel new-drug approvals during his run for the presidential nomination.
Following that vote, Sanders told USA Today that some of his Democratic colleagues didn’t have the “guts” to stand up to pharma’s interests. CNBC's Jake Novak wrote afterward that the vote outlines new "battle lines" in pharma's pricing war.
Klobuchar, Grassley and McCain’s proposal is identical to importation guidelines set out by the latter two senators back in 2015. But this time, they might find support from Trump, who endorsed drug importation on the campaign trail.