FDA, HHS Share Proposed Action Plan for Safe Drug Importation

In a joint effort, the US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) have announced the Safe Importation Action Plan, a project designed to lower out-of-pocket costs, which defines two possible pathways to safely import prescription drugs from foreign markets.

The proposal builds upon President Trump’s blueprint to lower drug costs for consumers and is based on the idea that pharmaceutical manufacturers would offer imported drugs at a lower price point under different national drug codes.

“President Trump has been clear: for too long American patients have been paying exorbitantly high prices for prescription drugs that are made available to other countries at lower prices. When we released the President’s drug pricing blueprint for putting American patients first, we said we are open to all potential solutions to combat high drug prices that protect patient safety, are effective at delivering lower prices, and respect choice, innovation, and access,” said Health and Human Services Secretary Alex Azar. “Today’s announcement outlines the pathways the Administration intends to explore to allow safe importation of certain prescription drugs to lower prices and reduce out-of-pocket costs for American patients. This is the next important step in the Administration’s work to end foreign freeloading and put American patients first.”

The first pathway comes in the form of a notice of proposed rule-making (NRPM), where HHS and the FDA hope to rely on authority under the currently existing Federal Food, Drug, and Cosmetic Act, allowing outlined plans from states, wholesalers, and pharmacists to be submitted to HHS for review and 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,” according to the HHS press release.

The second pathway would grant opportunity to manufacturers to import drugs from foreign markets if it can be proven that they are the exact replica of the US sold versions but sold using a new national drug code. Using a new drug code would allow them to potentially lower prices. The HHS press release highlights that this second pathway would be specifically helpful for medications like insulin and drugs used to treat rheumatoid arthritis, cardiovascular disorders, and cancer.

“We support the President and Secretary’s efforts to bring down drug prices for Americans. 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. “Driving down drug prices requires a comprehensive approach and we must continue to look at all innovative solutions to this challenge. 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. We’ve been keenly focused on ensuring the importation approaches we’ve outlined pose no additional risk to the public’s health and safety. 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.”—Edan Stanley