WASHINGTON — The Trump administration on Wednesday said it was taking steps that might eventually lead to the importation of some lower-cost prescription drugs from Canada, an idea supported by President Donald Trump but long opposed by many Republicans, including some of his own top aides.
The effort is the administration’s latest to lower drug prices, which the president has made a top priority ahead of the 2020 presidential election. Trump has ramped up pressure on advisers to deliver wins on the issue which consistently polls as a top voter concern.
The plan would allow state governments, pharmacies and drug manufacturers to come up with proposals for safe importation and submit them for federal approval. The shift was hailed in Maine, where the Legislature moved this year to pass a bipartisan package of bills aimed at lowering drug prices, including one to begin a Canadian drug importation program.
Top officials at Health and Human Services and the Food and Drug Administration said they plan to publish a “Safe Importation Action Plan,” outlining two measures the administration could take to allow Americans to purchase lower-cost versions of some medicines from Canada. 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.
Maine Gov. Janet Mills, a Democrat, said in a Wednesday statement that she had spoken with HHS Secretary Alex Azar and told him the state will “take advantage” of the rule, calling it a “positive step” and saying no Mainer “should have to choose between their health and other necessities like food, fuel or housing.”
“For the first time in HHS’s history, we are open to importation,” Azar said on a call with reporters. “What we’re saying today is we’re open. There is a pathway. We can be convinced.”
Experts on the FDA’s regulatory process said it could take two to three years for the agency to issue a final rule allowing importation from Canada. While some rules are developed faster than that, this one is likely to be complicated, they said. They were also skeptical any drugs would be able to meet all the safety criteria included in such a rule.
Azar himself dismissed the idea of importation as a “gimmick” last year because there would be no way 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 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.
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 that the overseas version of the drug is the same as the FDA-approved version, and allow Americans to purchase the same drug for less money.
Nevertheless, the plans face steep hurdles. Drug industry groups immediately criticized the proposal, and it is unlikely a significant number of manufacturers would choose to import overseas versions of their drugs that would yield lower profits.
“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 StevenUbl, president and chief executive officer of PhRMA, the drug industry lobbying group.
In addition, the Canadian government has 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.
“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,” said Craig Garthwaite, director of the health care program at Northwestern University’s Kellogg School of Management. “I don’t think they’re going to move U.S. prices that much.”
The industry has also brought legal challenges against other Trump administration initiatives it has opposed. Azar said administration officials had not spoken with drugmakers about their latest effort.
BDN writer Michael Shepherd contributed to this report.