The Trump administration finalized a rule late Thursday that would pave the way for states like Florida to import cheaper drugs from Canada.
The Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) also finalized guidance to enable drug manufacturers to voluntarily reimport their products authorized for sale in another country.
“The Safe Importation Action Plan aims to clearly describe procedures to import drugs that would lower prices and improve access while also maintaining the high quality and safety Americans expect and deserve,” said FDA Commissioner Stephen Hahn, M.D., in a statement.
The rule allows states, Indian tribes and in certain future circumstances pharmacists and wholesalers to submit proposals to the FDA for review and authorization.
If the FDA approves the proposal, the state can import certain prescription drugs in Canada that meet the agency’s safety regulations.
“Eligible prescription drugs would have to be relabeled with the required U.S. labeling and undergo testing for authenticity, degradation and to ensure that the drugs meet established specifications and standards,” HHS said in a release.
The importation programs also must demonstrate “significant cost reductions” for the covered products.
Senior administration officials didn’t put a price tag on potential savings during a call Friday.
“Given massive price differentials we are very confident the savings could be very substantial,” one official said.
Several states such as Florida have already started to put together an importation plan and could be the first to get approval from the FDA.
Insulin drugs are excluded from the program. However, the FDA finalized a guidance that shows drug manufacturers how to obtain a national drug code for certain FDA-approved biological products originally manufactured and intended for sale in foreign countries.
“The use of an additional NDC for these products may allow greater flexibility for drug companies to offer these products at a lower price than what their current distribution contracts require,” HHS said.
The agency is also soliciting proposals for a regulation that would enshrine personal reimportation. The individual could apply for a waiver for a specific drug, get a valid prescription and then get the reimported drug from an American pharmacy.
Currently it is illegal for individuals to reimport products from Canada or other countries, but the FDA does not normally enforce this provision against individuals.
But HHS didn't comment on whether Canada was on board with any reimportation proposals. The country has vociferously opposed national reimportation measures because of concerns it would dwindle their own drug supplies.
The Health Resources and Services Administration (HRSA) also issued a notice of proposed rule-making concerning community health centers.
The notice requires any insulin or buprenephrine that the centers get via the 340B drug discount program be offered to patients at the discounted rate.
“These discounted drugs will be available to health center patients with low income who also have health insurance with a high cost-sharing requirement for either insulin or injectable epinephrine, health insurance with a high unmet deductible, or no health insurance,” the HRSA said in a release.