The Safe Importation Action Plan offers 2 avenues importing drugs originally intended for foreign markets.
HHS and the FDA have unveiled a new action plan to pave the way for the importation of certain prescription drugs from other countries. The Safe Importation Action Plan offers 2 avenues for importing drugs originally intended for foreign markets.
Under the first pathway, HHS and the FDA through a notice of proposed rulemaking would draw on the authority of the Federal Food, Drug, and Cosmetic Act Section 804, which when finalized would allow states, wholesalers, or pharmacists to propose demonstration projects outlining how they would import certain prescription drugs from Canada and submit to HHS for review.
The drugs would have to be versions of FDA-approved drugs that are manufactured consistent with the FDA approval. The pathway would not allow for the importation of biologics, intravenous drugs, or controlled medicines. Notably, states or other entities would not be able to import insulin, whose prices have been at the forefront of high drug cost conversations and have resulted in patients with diabetes making the trip to Canada to stock up on lower-priced drugs.
According to HHS, the pathway would include stipulations to ensure the importation offers no additional risk to patients and that the demonstration projects result in significant cost savings for consumers.
“Access to affordable prescription drugs can be a matter of life or death for American patients,” said HHS Secretary Alex Azar during a press call about the plan. “The president has heard how much this matters to Americans, and we at HHS have heard the same. We all know how unfair it is that other countries are paying lower prices for the same drugs, and we’re taking action.”
The second pathway could potentially allow for importation of a much broader class of drugs and from all countries, explained Acting FDA Commissioner Ned Sharpless, MD, during the press call. These could include insulins, as well as drugs to treat rheumatoid arthritis, cardiovascular diseases, and cancer.
Under this pathway, the FDA would offer recommendations to manufacturers who want to import US versions of drugs they currently sell in other countries. Under the pathway, manufacturers would be able to use a New Drug Code for these drugs, which could potentially allow them to come on to the market at a lower list price.
“Driving down drug prices requires a comprehensive approach and we must continue to look at all innovative solutions to this challenge,” said Sharpless in a statement. “Today’s proposal is the result of the hard work by the dedicated staff of the FDA, in close collaboration with HHS and the White House, to identify potential pathways we can pursue to support the safe importation of certain prescription drugs.”
In order to use the second pathway, the manufacturer would have to show the FDA that the foreign version is the same as the US version and appropriately label the drug for sale in the United States.