HHS Announces Safe Importation Action Plan for High Medication Costs

August 20, 2019 by Alec Stone MA, MPA, ONS Government Affairs Director
alec stone
Alec Stone MA, MPA, ONS Public Affairs Director

The high cost of prescription medications—often lifesaving drugs—has become an unsustainable burden for many American patients. It’s a central topic in the healthcare conversation and a complex issue with countless moving parts. National opinion polling finds that a majority of people want to see changes in drug pricing.

Both the House and Senate have held hearings with pharmaceutical leaders to question pricing strategies, and President Trump has come out forcefully in favor of lower rates for patients. Still, the great debate rages on concerning effective and safe ways to lower prescription drug costs. One solution, importing drugs from other countries to use their pricing model, has been popular among many on Capitol Hill.

The U.S. Food and Drug Administration (FDA) has been concerned about importing medications from foreign countries, citing potential safety issues and lack of oversight in a drug’s country of origin. In response, the Department of Health and Human Services (HHS) released its Safe Importation Action Plan to investigate options to lower the prices for prescription medications in the United States.

“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,” HHS Secretary Alex Azar said.

The HHS plan has two routes that would allow medications into the country:

  1. HHS would authorize pilot projects outlining strategies to import certain drugs from Canada that are versions of FDA-approved drugs and are manufactured in accordance with those FDA approvals.
  2. Through guidance, FDA would provide recommendations to manufacturers of FDA-approved drugs who seek to import into the United States versions of those drugs they already sell in foreign countries.

Any long-term plan would require congressional oversight for sustained support. Ultimately, the current administration is looking for novel ways to provide safe and effective alternatives for patients with chronic diseases to be able to access affordable prescription medications.


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