US to allow drug imports from Canada
WASHINGTON – The Trump administration said Wednesday it will create a way for Americans to legally and safely import lower-cost prescription drugs from Canada for the first time, reversing years of refusals by health authorities amid a public outcry over high prices for life-sustaining medications.
The move is a step toward fulfilling a 2016 campaign promise by President Donald Trump, and it weakens an import ban that has stood as a symbol of the political clout of the pharmaceutical industry. It’s unclear how soon consumers will see benefits, as the plan has to go through time-consuming regulatory approval and later could face court challenges from drugmakers.
It comes as the industry is facing a crescendo of consumer complaints over prices, as well as legislation from both parties in Congress to rein in costs, along with a sheaf of proposals from the Democratic presidential contenders. Ahead of the 2020 election, Trump is feeling pressure to deliver on years of harsh rhetoric about the pharmaceutical industry.
Making the announcement Wednesday, Health and Human Services Secretary Alex Azar said the administration’s decision recognizes that prescription drug manufacturing and distribution is now international.
“The landscape and the opportunities for safe linkage between drug supply chains has changed,” Azar said. “That is part of why, for the first time in HHS’s history, we are open to importation. We want to see proposals from states, distributors and pharmacies that can help accomplish our shared goal of safe prescription drugs at lower prices.”
Stephen Ubl, president of the industry group Pharmaceutical Research and Manufacturers of America, called the plan “far too dangerous” for American patients. “There is no way to guarantee the safety of drugs that come into the country from outside the United States’ gold-standard supply chain,” Ubl said in a statement. “Drugs coming through Canada could have originated from anywhere in the world.”
Most patients take affordable generic drugs to manage conditions such as high blood pressure or elevated blood sugars.
Polls show concern about the prices of breakthrough medications for intractable illnesses like cancer or hepatitis C infection, whose annual costs can run to $100,000 or much more. And long-available drugs like insulin have seen serial price increases that forced some people with diabetes to ration their own doses.
Azar, a former drug company executive, said U.S. patients will be able to import medications safely and effectively, with oversight from the Food and Drug Administration.
One prong of the administration’s proposal would allow states, wholesalers and pharmacists to get FDA approval to import certain medications that are also available here. Trump had recently endorsed a new Florida law to allow importation.
Another part of the plan would allow drugmakers to seek approval for reimportation of their own drugs. This second provision would cover cuttingedge biologic drugs as well mainstays like insulin, and it could apply to drugs from other countries besides Canada.