HHS Safe Importation Action Plan

The U.S. Department of Health and Human Services (HHS) announced today that HHS and the U.S. Food and Drug Administration (FDA) are publishing a Safe Importation Action Plan – PDF* that outlines two potential pathways that would lay the foundation for the safe importation of certain drugs originally intended for foreign markets.

“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 – PDF 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 Action Plan outlines the government’s intention to pursue two pathways to allow safe drug importation from foreign markets:

1. Through a notice of proposed rulemaking (NPRM), HHS and FDA would propose to rely on the authority under current federal law (Federal Food, Drug, and Cosmetic Act (“FD&C Act”) Section 804) 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.
2. 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.

“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, M.D. “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.”

President Trump and Secretary Azar continue to explore all ways to tackle the soaring price of prescription drugs while protecting incentives for innovation and maintaining standards of quality to promote patient safety and access to needed medicines. Today’s Action Plan outlining the Department’s proposal is a follow-up to work that HHS and FDA have done together to explore solutions to improving Americans’ access to lower-cost versions of drugs that have seen significant price increases or significant access challenges for patients. It reflects an ongoing effort by the Trump Administration to respond to the concerns of the American people and to encourage action by Congress to make healthcare more affordable.

The FDA has delivered historic levels of generic drug approvals during the Trump Administration, with the Council of Economic Advisors estimating the savings generated from generic approvals in the first 18 months of the Trump Administration to be $26 billion. The Trump Administration’s drug pricing plan has also delivered the biggest 12-month decrease in over 50 years of the prescription drug component of the Consumer Price Index, the official government measure of drug price inflation.

For more information:

• Safe Importation Action Plan – PDF*
• President Donald J. Trump’s Blueprint To Lower Drug Prices
• HHS Secretary Azar Directs FDA to Establish Working Group on Drug Importation to Address Price Spikes

View original press release.