The US Department of Health and Human Services (HHS) said the Trump administration is pushing ahead with a plan to allow certain prescription drugs to be imported from Canada. “For the first time in history HHS and FDA are open to importation as a means for lower prices,” commented HHS Secretary Alex Azar, adding that “today’s announcement outlines two pathways for the safe importation of certain prescription drugs to help provide safe, effective, more affordable drugs to American patients.”
Specifically, HHS along with the FDA have issued a so-called “notice of proposed rulemaking” that, if approved, would allow states to submit importation program proposals explaining how they would work with pharmacies and other parties to bring in drugs from Canada. “Notably, these programmes would also have to demonstrate significant cost reductions to the American consumer,” HHS said.
The proposals would be submitted for review and authorization by the FDA, whose new commissioner Stephen Hahn was recently confirmed. Eligible prescription drugs would have to meet the conditions in an FDA-approved drug application and be relabeled with the required US labeling prior to importation. The products would also be tested for authenticity and to ensure they meet established specifications and standards.
Moreover, the HHS department released draft guidance explaining how pharmaceutical companies could obtain an additional national drug code for certain prescription drugs, including biological products, that were originally manufactured and intended for sale in a foreign country. “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, they could issue that drug at a lower list price, bringing savings to patients at the pharmacy counter,” Azar said. Products imported under the pathway described in the draft guidance could be available to patients in various settings, including hospitals, doctors’ offices or licensed US pharmacies.
Azar added that “new pathways for importation can move us toward a more open and competitive marketplace” for prescription products. Four US states, including Florida, Vermont, Colorado and Maine, recently passed legislation to set up drug importation programmes, although any action would require HHS approval. Meanwhile, the Trump administration has also proposed basing US drug prices on a “favoured nations” plan, under which the US would pay no more for drugs than the country with the lowest prescription prices.
Canadian officials have warned aagainst plans by the US to import drugs from the country, with a spokesperson for Canada’s health ministry recently saying “our government would oppose any initiatives that could adversely affect the supply of prescription drugs in Canada or the costs for Canadians.” Azar did not say whether the US administration’s current plan had been discussed with Canadian authorities.
Commenting on the news, Jim Greenwood, head of the Biotechnology Innovation Organization (BIO), predicted the importation plan would not result in lower prices for consumers. He called the move “the latest empty gesture from our elected lawmakers who want us to believe they’re serious about lowering patients’ prescription drug costs.”