FDA issues final rule allowing importation of drugs from Canada — but also keeps the power to revoke it
Just over a month away from the presidential election, the FDA has issued a final regulation fulfilling President Trump’s promise to let states import certain prescription drugs from Canada.
On Thursday, Trump told a crowd in North Carolina that the new rule goes into effect “today.” But the published regulation states that it won’t take effect for 60 days. And even then, it could be a while before cheaper drugs make it across the border.
According to the rule, states, territories, tribes, pharmacists and wholesalers would need to set up new programs and apply to import the drugs, which would have to meet several specifications. The products would need to be relabeled and tested for “authenticity and degradation,” according to the FDA. And the programs must demonstrate “significant cost reductions” to the consumer.
“If you put Canadian drugs on a dogsled and pointed it in the direction of Florida, the dogs would arrive long before any drugs through this regulatory proposal,” former HHS official Chris Meekins told the Washington Post back in December.
Trump signed an executive order in July directing the FDA to complete the “rulemaking process” to allow the importation of Canadian prescription drugs. Under a law established in 2003, such importation is only allowed if certified by the HHS secretary. Alex Azar has become the first secretary to formally do so.
Drugs that have been approved by Canada’s Health Products and Food Branch and meet the conditions of an FDA-issued NDA or ANDA will be eligible. In a press briefing on Friday, HHS chief of staff Brian Harrison said that safety has been “at the forefront of our efforts.”
“We’ve created smart safe opportunities for Americans to secure lower cost of drugs through importation as no president has ever done before,” Harrison said in the briefing.
But others are skeptical that the regulation will be effective in lowering drug costs. In a New England Journal of Medicine Perspective piece published in May, Washington University associate law professor Rachel Sachs and University of Michigan law professor Nicholas Bagley suggested the Trump administration could be doing more to make drugs affordable.
“Far from a bold initiative to help people afford their prescription drugs, the proposal seems designed to allow the Trump administration to claim that it is taking action, even as it opposes congressional legislation that would sharply curb some drug prices,” the piece states.
Bagley and Sachs also pointed out that the initial proposal lacked guidance on how states can prove the imported drugs will reduce costs. Canadian regulators could change their rules to discourage exportation, or savings could benefit the wholesalers or the health care providers prescribing the drugs, rather than patients, they said. “Importation might still save money, at least for some drugs, but a raw comparison of prices in the United States and Canada provides very thin support for that conclusion.”
Alexander Gaffney of Politico’s AgencyIQ noted that the finalized regulation includes language which could allow the FDA to revoke importation programs.
There's also a bunch of new language that allows the FDA to revoke importation programs because – get this – it is "too much of a burden on FDA or HHS resources."
That seems like a blank check to end these programs whenever it wants. pic.twitter.com/CP2QmW2D5s
— Alexander Gaffney (@AlecGaffney) September 25, 2020
“This will be a game-changer for American seniors,” Trump touted Thursday in a speech presenting his America First healthcare plan. “And by allowing you to do this through Canada, we’re doing it very, very quickly. So it goes very fast.”
The president also promised $200 prescription drug coupons to Medicare beneficiaries, which he said will come from $6.6 billion in savings that do not currently exist — or from pharma’s coffers.