On Wednesday, the U.S. Department of Health and Human Services (HHS) released President Donald Trump’s plan to allow importation of prescription drugs from foreign countries. As STAT News explained, the plan creates “two pathways for importation. One would let states, drug wholesalers, or pharmacies apply to import certain drugs from Canada. … A second would let drugmakers import their own products sold in other countries.”
While the administration made a huge press push in support of the plan, coverage also highlighted significant concerns about the proposal. STAT News reported former Food and Drug Administration Commissioner Scott Gottlieb panned the proposal on Twitter on Tuesday. Gottlieb said, “Our closed drug system doesn’t allow imports of unapproved foreign drugs for key historical reasons. … We should not open up a side channel for foreign drugs.”
Why not?
Because this proposal is unsafe, unworkable, and would be ineffective.
Gerard Anderson, a professor at the Johns Hopkins Bloomberg School of Public Health, told Pew Charitable Trusts that he is “suspicious that with importation you can guarantee the safety of the distribution networks through other countries.”
Citing patient safety concerns, members of the president’s own party even came out against the idea. State Sen. Jim Smallwood, and Republican from Colorado, said, “If you support something like this, you’re supporting conceding to a foreign power the efficacy and safety of drugs sold in the United States. … I’m not willing to do that.”
We discussed these safety concerns in depth in the statement we released after the HHS announcement.
During a week in which the U.S. House of Representatives voted to ratify a major trade deal between the United States, Mexico, and Canada, the president’s importation plan also angered our neighbors to the north. Daniel Chiasson, president of the Canadian Association for Pharmacy Distribution Management, told Reuters, “The drug supply is insufficient for the Canadian market, let alone trying to divert it to a much larger market like the U.S. … We’re not supportive of any policy initiative or policy proposal that has the capacity to threaten the stability of medications available to Canadians.”
American Action Forum Director of Health Policy Chris Holt told Morning Consult that the Canadian Parliament could take action against the Trump administration’s policy. He said, “[T]here’s the reality that the Canadians don’t sound very excited about this. … They could very easily take legislative action in their country to prohibit the importation of drugs to the U.S. or to give assurance that they won’t have drug shortages.”
There also are questions about whether drug importation actually will impact the price of life-saving treatments. On Twitter, Kaiser Family Foundation Medicare expert Juliette Cubanski said, “Like allowing Medicare to negotiate prices, drug importation has been discussed for years. … But there is much uncertainty about potential savings from importation.” She noted the Trump administration rule did not include a cost-benefit analysis. Shabbir Safdar, executive director of the Partnership for Safe Medicines, told Morning Consult, “The key here is that this will not save Americans money; it will cost Canadians more and endanger patients in both countries.”
Even officials still serving in the Trump administration have questioned drug importation. In a media briefing in 2018—while he was serving in his current capacity—HHS Secretary Alex Azar called importation a “gimmick.” He argued then that “you can’t improve competition and choice in our drug markets with gimmicks like these—you have to boost competition and price transparency.”
We agree and, thankfully, as The New York Times noted, this proposal “is still a long way from being finalized.”