The Trump administration opened the door Wednesday to allowing Americans to import drugs from Canada and other foreign markets, reversing long-standing U.S. policy as President Trump searches for ways to make good on his campaign promise to bring down prices.
Pharmaceutical companies were spooked. They feared a dent to their bottom line and warned of safety concerns.
But the government said consumers could see real savings and said the global market has improved enough to have confidence that products sold elsewhere are the same as what is available in the U.S.
“The landscape and the opportunities for safe linkage between drug supply chains has changed,” Health and Human Services Secretary Alex Azar said. “That is part of why, for the first time in HHS’s history, we are open to importation.”
He outlined two pathways for bringing in the drugs.
One proposed rule would allow states, drug wholesalers and pharmacists to seek federal approval of plans to import drugs from Canada that are safe versions of drugs approved by the Food and Drug Administration.
The second route, through draft guidance, would let companies bring in versions of drugs they sell abroad and use a special national code to offer U.S. consumers lower prices than what their current distribution contracts require.
It’s a notable evolution for a Republican administration. For years, Republicans have looked askance at drug importation, citing safety concerns, and the powerful pharmaceutical lobby has kept the idea at bay.
“We can be convinced,” Mr. Azar said. “We’re saying here’s the criteria, here’s the road map.”
The Department of Health and Human Services said it is committed to implementing the plan quickly and promises updates in the coming months.
The price of prescription drugs is a top concern for voters, so pressure had been mounting in state capitals to look abroad.
Florida Gov. Ron DeSantis, a Republican and Trump ally, pushed for a state law on Canadian importation and nudged the White House to support the plan, which dovetails with the president’s belief that U.S. consumers are being gouged by the prescription drug industry.
Stories of consumers paying 10 times more for insulin in the U.S. than what they get across the border in Canada have angered policymakers on both sides of the aisle.
Sen. Bernard Sanders, a leading Democratic presidential candidate, made a highly publicized trip this week from Detroit to Windsor, Ontario, to prove the point. He brought with him a dozen or so Americans who need insulin to treat diabetes.
Mr. Sanders held up a vial he said would have cost about $340 with a prescription in the U.S. but is sold over the counter for about $30 in Windsor, according to the Canadian Broadcasting Corp.
Mr. Trump says other nations are “freeloading” on American consumers, whose higher costs ostensibly subsidize the industry’s research and development of cures for diseases.
The president has floated plans to force prices under Medicare to levels on par with those of other developed nations.
Some of Mr. Trump’s other ideas have run aground. A federal judge blocked his push to force pharmaceutical companies to disclose list prices in TV ads, and he recently withdrew a plan to pass drug rebates directly to Medicare recipients, fearing it would increase the premiums for Medicare’s prescription drug benefit program.
Mr. Azar said the administration will press on.
“We heard about the pain Americans are feeling at the pharmacy counter,” he said. “We learned that this was impacting Americans’ health, and we’re taking action.”
The FDA has experience with foreign inspections, and other industrialized nations don’t have problems with drug safety, said Gerard Anderson, a professor at the Johns Hopkins Bloomberg School of Public Health.
“The main challenge will be making sure that the suppliers are legitimate. How do you know the mail order company is safe?” he said.
The Pharmaceutical Research and Manufacturers of America, the main industry lobby that opposes the plan, focused on that issue, saying importation could jeopardize safety or exacerbate the opioid crisis.
“The administration’s importation scheme is far too dangerous for American patients,” PhRMA President and CEO Stephen J. Ubl said. “There is no way to guarantee the safety of drugs that come into the country from outside the United States’ gold-standard supply chain. Drugs coming through Canada could have originated from anywhere in the world and may not have undergone stringent review by the FDA.”
Lamar Alexander, Tennessee Republican and chairman of the Senate Committee on Health, Education, Labor and Pensions, said he welcomes importation but added that federal regulators must keep a close eye on incoming products.
“The key for me is whether this plan preserves the Food and Drug Administration’s gold standard for safety and effectiveness,” Mr. Alexander said. “Millions of Americans every day buy prescription drugs relying on the FDA’s guarantee of quality.”
Sen. Jeanne Shaheen, New Hampshire Democrat, said the plan is a long time coming but the test will be whether consumers end up paying less.
“There is no reason why they should be paying more than our neighbors to the north for the same medications,” she said. “This plan is a good initial step to help drive down costs. I hope that the administration will make it clear that savings from drug importation need to be passed along to patients, rather than pocketed by pharmacies and distributors.”
Trump officials said their plan is structured to help a broad swath of patients. For instance, people who rely on biologics such as insulin cannot rely on demonstration projects from states or companies, though the administration says those drugs can flow through the second pathway, which allows companies to use special pricing codes.
Mr. Azar said he has spoken with Canada’s health ministry to try to ease fears about the plan north of the border.
Canadian pharmacy and health care groups said they are worried that importation could sap their own supplies.
“While we recognize the priority that American governments have placed on reducing the costs of prescription medicines in the U.S.,” they wrote on July 25, “we are concerned that the legal and policy frameworks that they have adopted may not address the root cause of their domestic concerns and will likely result in increased drug shortages in Canada.”
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