HHS Secretary Directs FDA to Create Drug Importation Working Group
The rising price of prescription drugs is an ongoing priority for the Trump administration. As part of the president’s blueprint to lower drug costs, the Department of Health and Human Services (HHS) secretary, Alex Azar, elevated the prescription cost issue throughout many federal agencies to help determine a new course of action.
Leading the efforts is the U.S. Food and Drug Administration (FDA). Azar challenged FDA to establish a new working group that will look into the pricing spikes in recent years. At a recent press conference (https://www.hhs.gov/about/news/2018/07/19/hhs-secretary-azar-directs-fda-establish-working-group-drug-importation-address-price-spikes.html), Azar said, “We have seen a number of both branded and generic examples in recent years where a single manufacturer dramatically hikes the price for a drug unprotected by patent or exclusivities. In the 2015 case of the drug pyrimethamine, we saw the list price of a drug approved by the FDA in 1953 increase by more than 5,000%.”
According to HHS, FDA’s working group will study the possibility of promoting competition for off-patent drugs or drugs produced by a single manufacturer. This differs from proposals to import a broader range of drugs from other countries, which raised questions about how to protect American patients with the influx of external medications. The working group will consider drugs unprotected by patents or exclusivities and will allow other manufacturers to introduce new competition to potentially drive down costs for consumers.
“Safe, select avenues for importation could be one of the answers to these challenges,” Azar said. “When HHS released the president’s blueprint for putting American patients first, I said we are open to all potential solutions—assuming they are effective, safe for patients, and respect choice, innovation, and access.”
Azar added that “importation may well fit that bill in some instances. We look forward to working with Commissioner Gottlieb on this issue and appreciate the voluminous work FDA has done to increase competition in America’s drug markets.”
As federal agencies and policymakers continue to address the rising costs of medications, ONS will share the important perspective of oncology nurses (https://www.ons.org/advocacy-policy). As the direct line to their patients, oncology nurses see the ways high-cost drugs can negatively impact a patient’s quality of life and financial well-being during and after treatments.