The Department of Health and Human Services (HHS) has announced that HHS and the Food and Drug Administration (FDA) are publishing a Safe Importation Action Plan that outlines two potential pathways that would lay the foundation for the safe importation of certain drugs originally intended for foreign markets.
HHS says the Action Plan is a follow-up to work that HHS and FDA have done together to explore solutions to improve Americans’ access to lower-cost versions of drugs that have seen significant price increases or significant access challenges for patients.
The Action Plan outlines the government’s intention to pursue two pathways to allow safe drug importation from foreign markets:
· Through a notice of proposed rulemaking (NPRM), HHS and FDA would propose to rely on the authority under current federal law that would, when the rule is finalized, authorize pilot (or demonstration) projects developed by states, wholesalers or pharmacists and submitted for HHS review, outlining how they would import certain drugs from Canada that are versions of FDA-approved drugs that are manufactured consistent with the FDA approval. The NPRM would include conditions to ensure the importation poses no additional risk to the public’s health and safety and that the demonstration projects would achieve significant cost savings to the American consumer.
· Through guidance, FDA would provide recommendations to manufacturers of FDA-approved drugs who seek to import into the U.S. versions of those drugs they sell in foreign countries. Under this pathway, manufacturers would use a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require. To use this pathway, the manufacturer or entity authorized by the manufacturer would establish with the FDA that the foreign version is the same as the U.S. version and appropriately label the drug for sale in the U.S. This pathway could be particularly helpful to patients with significantly high cost prescription drugs. This would potentially include medications like insulin used to treat diabetes, as well as those used to treat rheumatoid arthritis, cardiovascular disorders, and cancer.
“The FDA has a unique role to play in promoting competition that in turn can help reduce drug prices and improve access to medicine for Americans,” said Acting FDA Commissioner Ned Sharpless, MD, in the statement. “Driving down drug prices requires a comprehensive approach and we must continue to look at all innovative solutions to this challenge. We know there are many operational challenges to address through each of these pathways and are actively working through them as we look to formally announce these policies, with opportunity for public comment, in the coming months.”
