The Trump administration unveiled a proposed rule and draft guidelines under a two-pronged approach to import drugs from Canada and other foreign nations into the U.S., without specifying a timeline for executing on the plans.
Health and Human Services Secretary Alex Azar said the administration also does not have a projection on any cost savings from importing drugs into the U.S.
The proposals had undergone a relatively short review by the White House Office of Management and Budget, which started its vetting process in early November.
HHS Secretary Alex Azar and President Donald Trump
The U.S. drug industry and Canadian officials have opposed the Trump administration's import plans.
The proposed rule, if finalized, would authorize U.S. states, potentially working with wholesalers or pharmacies, to develop programs that would allow importation of certain prescription medicines from Canada.
Azar said the administration has received "strong interest" from U.S. state governors in both political parties, including Republicans Ron DeSantis of Florida, Phil Scott of Vermont and Chris Sununu of New Hampshire and Democrats Janet Mills of Maine and Jared Polis of Colorado.
But the HHS secretary said it was unclear which states would come forward with plans.
"We don't know what those plans will be, we won't know which particular drugs will be in their plans and we don't know the volume," he told reporters during a Dec. 17 briefing.
Florida submitted a draft plan to HHS in August, while Colorado said it was working on a proposal.
To be eligible under the proposed rule, a drug must be approved by Health Canada and would need to meet the conditions of a U.S.-approved new drug application.
Not all types of medicines are eligible, including biological products and other injectables, particularly insulin — generally the most expensive therapies sold in the U.S.
The administration is taking public comments on the proposed rule for 75 days, though there is no timeline for going through that feedback.
"We will expeditiously review the comments and determine whether and how to go final with the rule, at which point we would be open for business for states or other government entities to come forward with plans and conformity with that," Azar said.
Importation by manufacturers
The draft guidelines for industry describe procedures that drug manufacturers could follow to facilitate importation of their products, including biological therapies, into the U.S., when the medicine is manufactured abroad, authorized for sale in any foreign country and originally intended for that overseas market.
Azar acknowledged drugmakers "would basically compete against your own product but at a lower list price" under the scenario.
The product must be the same as the therapy approved by the U.S. Food and Drug Administration, officials said. The FDA would issue those imported medicines a new national drug code, a unique 10-digit, 3-segment number that serves as a universal product identifier for U.S. medicine.
"What drug companies have told us, and we'll have to see if they live up to this, is that if they could only get a new national drug code for that exact same drug — the exact same drug — that they could issue that drug at a lower list price bringing savings to patients at the pharmacy counter," Azar said.
The draft guidelines recommend that manufacturers include a statement on their product's label and in any other prescribing information to assist pharmacists to accurately identify, dispense and bill for those medicines, Brett Giroir, assistant secretary for health at HHS, told reporters.
Azar acknowledged the proposed rule and the draft guidelines were largely consistent with the outline the administration presented in July.
"This is just the fleshing out of all of the legal and implementation parameters of it," Azar said.
He noted no other administration has ever had an FDA willing to open the door to the importation of drugs.
Former FDA chief objects
New FDA Commissioner Stephen Hahn, who was sworn in Dec. 17, is charged with carrying out the administration's plans.
When he was FDA commissioner, Scott Gottlieb was under an edict to find a safe pathway for importation, but he left the administration less than two years into the job.
Since then, he has been vocal at events and on Twitter that he opposes drug importation.
"Our closed drug system doesn't allow imports of unapproved foreign drugs for key historical reasons," Gottlieb tweeted on Dec. 17 ahead of the administration unveiling its proposals.
He noted that Capitol Hill had adopted two laws specifically to try to prevent counterfeit medicines from entering the U.S. drug supply chain — the Prescription Drug Marketing Act of 1987 and the Drug Quality and Security Act.
"We should not open up a side channel for foreign drugs outside of the established controls" of those two laws, Gottleb tweeted.
Even Azar initially called drug importation a "gimmick" in his first few months in office, though he later said the administration was trying to find a safe way to make it happen.
The Trump administration's two-part plan is being proposed under the 2003 Medicare Modernization Act, which included a clause that legalized drug importation under certain circumstances if the HHS secretary deemed it safe.
Currently, it is illegal for individual Americans to import drugs or medical devices into the U.S. for personal use.
A medicine approved for use in another country but not cleared by FDA would be considered an unapproved drug in the U.S. and therefore illegal to import, according to the agency.
Azar emphasized the administration's plans do not involve personal importation of drugs.
"I must caution that when one goes online and buys drugs that are supposedly from Canada or supposedly from a Canadian drugstore, you are taking your life into your own hands," he told reporters.