The Trump administration released two policy drafts Dec. 18 that, if enacted, would allow the importation of prescription drugs from other countries, according to STAT.
The policies create two paths for importation. The first would allow states, drug wholesalers and pharmacies to apply to import certain drugs from Canada with the approval of HHS.
The second would let drugmakers voluntarily import their own drugs sold in other countries. It would give the imported drugs a new identification number, which should allow the drugmakers to offer their drugs at a lower price without facing backlash from pharmacy benefit managers who profit more on higher-priced drugs, according to STAT.
Both policies still need to go through a formal regulatory review, which could take months or longer. The administration said it is moving quickly to push the policies forward.
"We will move as quickly as humanly possible here," HHS Secretary Alex Azar said at a Dec. 17 news conference. "President Trump is fervently committed to bringing down drug prices, fervently committed to the importation of safe drugs from Canada."
The idea of importing drugs from other countries has been highly controversial, and drugmakers, wholesalers and pharmacists have all spoken out about it, according to STAT. They argue importation could put American patients at risk.
Former FDA Commissioner Scott Gottlieb, MD, also tweeted Dec. 17: "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."
But HHS Secretary Alex Azar has insisted that importation can be done safely.
"We will not take steps that would put patients, or our drug supply, at risk," Mr. Azar reportedly said at the news conference.
Several states have recently passed laws requiring their state administrations to submit plans to HHS on how they would import drugs. Florida submitted its plan in August, Colorado plans to submit its by Jan. 15, and Maine plans to submit its by May 1, according to STAT.
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