Federal health officials have unveiled plans to allow prescription drug imports from Canada and other foreign nations.
The U.S. Food and Drug Administration is proposing a rule under which states could import some prescription drugs from Canada, U.S. Health and Human Services Secretary Alex Azar announced recently.
The agency also plans to make it easier for drug manufacturers to import their own FDA-approved drugs that are manufactured abroad and intended for sale in other countries.
“This would potentially allow for the sale of these drugs at lower prices than currently offered to American consumers, giving drug makers new flexibility to reduce list prices,” Azar told reporters.
Azar touted the proposals as “historic.”
All imported drugs would have to be FDA-approved, tested to ensure quality and relabeled to meet U.S. labeling requirements, added Admiral Brett Giroir, the assistant secretary for health.
State programs created to import medications would be limited to pills that patients would typically get from a pharmacy, Azar said.
Injectable products, controlled substances, biologic products and intravenous drugs would not be allowed.
States would create these programs, possibly in conjunction with wholesalers or pharmacies, and then submit them to FDA for approval, Giroir said.
However, drug manufacturers would be able to import any of their own products from other foreign countries, Azar said. That would include products such as insulin, which has recently been subject to steep price hikes.
“Every product is available for importation from every country by a manufacturer,” Azar said. “There is no restriction there, if a manufacturer is willing.”
The manufacturer pathway is intended to address the “bizarre” system of drug rebates that some pharmaceutical companies have blamed for high prices, Azar said.
“Even if the drug company would like to lower the list price of their drug, they may actually be precluded from doing so because of their arrangements with these middle men, where they have to funnel a certain amount of rebate money to those middle men,” Azar said.
Drug companies have said if they can get a new National Drug Code for an imported version of the exact same medicine, then they would compete against their own products at a lower list price, Azar said.
The new proposals are only aimed at brand-name drugs, Giroir said.
“The draft guidance does not address generic drugs because we are not aware of similar private market challenges for reducing the cost of generic drugs,” Giroir said.
The FDA is open to considering similar proposals for generic if warranted, he added.
The officials could not say how soon patients will benefit from these proposals, but said that the manufacturer’s guidance will likely move faster because it faces fewer regulatory hurdles.