The plan would allow state governments, pharmacies and drug manufacturers to come up with proposals for safe importation and submit them for federal approval.
Top officials at Health and Human Services and the Food and Drug Administration outlined two measures the administration could take to allow Americans to purchase lower-cost, Canadian versions of some medicines. That could potentially include insulin — whose price rose about 300 percent from 2002 to 2013 — as well as drugs for rheumatoid arthritis, cancer and cardiovascular disorders, HHS said.
“For the first time in HHS’s history, we are open to importation,” HHS Secretary Alex Azar said on a call with reporters. “What we’re saying today is we’re open. There is a pathway. We can be convinced.”
But experts on the FDA’s regulatory process said it could take two to three years for the agency to issue a final rule allowing drug importation from Canada. While some rules are developed faster than that, this one is likely to be especially complicated — and the administration is still months away from formally proposing it, they said. They were also skeptical any drugs would be able to meet all the safety criteria included in such a rule.
“Politics are trumping policy and the law,” said Adam Fein, chief executive officer of Drug Channels, a business research company.
Azar himself dismissed the idea of importation as a “gimmick” last year because he said it would be difficult to ensure counterfeit drugs from other countries are not routed through Canada. On Wednesday, he said that the agency’s proposed pathways would ensure the U.S. drug supply remains safe.
The first pathway he and other officials described would authorize states, wholesalers or pharmacists to propose demonstration projects to import a select number of drugs from Canada that are similar versions of FDA-approved drugs. Those plans would still require federal approval.
Florida has already proposed importing drugs from Canada, an initiative all but certain to receive approval from the Trump administration.
The second pathway would have the FDA provide recommendations to manufacturers who want to import overseas cheaper versions of their medications into the U.S. The manufacturer would have to prove to the FDA the overseas version of its drug is the same as the FDA-approved version, and allow Americans to purchase it for less money.
Azar said administration officials had not spoken with drugmakers about their latest effort, and drug industry groups immediately criticized it.
“In the words of Secretary Azar just last year, drug importation is a ‘gimmick’ and ‘the last thing we need is open borders for unsafe drugs,’” said Steven Ubl, president and chief executive officer of PhRMA, the drug industry lobbying group.
Drug manufacturers are also unlikely to choose to import overseas versions of their drugs into the U.S., and receive lower profits. Most other developed countries pay lower prices because they negotiate with drug companies — something barred by U.S. law. The industry has already brought legal challenges against other Trump administration initiatives it has opposed.
Meanwhile, the Canadian government along with Canadian medical, pharmacy and patient groups have warned of drug shortages for its 37 million residents if its medicines are imported on a larger scale for the United States’s more than 300 million residents.
“The Canadian medicine supply is not sufficient to support both Canadian and U.S. consumers,” the groups said in a letter last week sent to the Canadian health minister.
Craig Garthwaite, director of the health care program at Northwestern University’s Kellogg School of Management, echoed that assessment.
“If you’re just trying to take Canadian drugs, it’s not going to do a whole lot for the U.S. given the [much bigger] size of the U.S. market,” he said.
Some experts said they were impressed by HHS’s proposals.
“The larger point shouldn’t be missed: We have a former executive from Eli Lilly, who once said importation was a gimmick and is now saying it can be done safely,” said Gabriel Levitt, president of PharmacyChecker.com, which verifies online foreign pharmacies for customers.