HHS launches safe importation action plan for prescription drugs

HHS is launching a new action plan for the safe importation of certain prescription drugs to bring in medications from foreign markets. The Safe Importation Action Plan extends recent actions from the Trump administration to make prescription drugs cheaper in the U.S.

“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.” HHS Secretary Alex Azar said in a statement. “This is the next important step in the Administration’s work to end foreign freeloading and put American patients first.” 

The plan has two pathways for the government to pursue:

  1. Through a notice of proposed rulemaking (NPRM) that would allow HHS and the FDA to authorize pilot projects for states, wholesalers and pharmacists to import certain drugs from Canada. The pilots must pose no risk to public health and safety and achieve “significant cost savings.”
  2. Manufacturers of FDA-approved drugs that want to import versions of U.S. drugs from foreign markets could do so under FDA recommendations and guidance with a new National Drug Code (NDC) for the products, which would potentially be offered at a lower price. This pathway is best suited for high-cost prescription drugs, such as insulin.

“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,” Acting FDA Commissioner Ned Sharpless, MD, said in a statement. “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."

The Trump administration has taken several steps over the past two years to take aim at sky-high prescription drug costs. HHS recently sent a proposal to base certain Medicare drug prices on an international index to the White House for consideration. The proposal was originally introduced in late 2018 and would lower the cost of Medicare Part B prescriptions 30% if implemented, representing savings of $17.2 billion over five years.

The White House has also recently penned a handful of executive actions to publish the list prices of prescription drugs, declare a favored nations clause and require hospitals and healthcare providers to post their prices of services online.

“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,” Azar said in a statement.

Despite these efforts, drug prices have continued to rise in the U.S. in 2019, and some patients with chronic diseases have even taken caravan trips to other countries to buy cheaper medications.