MedBen Senior Vice President Caroline Fraker was a featured speaker at the 10th Annual Sherrill-Morgan Healthcare Innovation Conference on September 15th. She spoke on the topic of drug importation, including the reimportation of U.S. manufactured prescription drugs back into the United States – a practice that, while unlawful, is gaining favor as U.S. drug prices soar. 

“Reimportation by anyone other than the original manufacturer is illegal,” Fraker said. “The only exceptions are if there is a drug shortage and HHS [Health and Human Services] approves reimportation, or if it’s under the authority of FFDCA Section 804, which gives HHS the authority to create regulations to establish a drug importation program.”

Toward the goal of reducing prescription drug costs, in 2020 then-HHS Secretary Alex Azar made a request to Congress for certification under Section 804 to allow for the importation of medications from Canada and other countries. Implementation of a final rule is ongoing.

Fraker noted that individual importation of unapproved drugs from a foreign country for personal use is similarly illegal – though, as with larger-scale importation, there are possible exceptions. “Drugs not used for treatment of a serious condition, such as over-the-counter drugs, might be allowed under FDA guidance. A drug for a serious condition might also be okay if no effective treatment is available in the U.S.,” she said.

In addition to federal efforts, 19 states have introduced legislation to allow for the wholesale importation of lower-cost drugs from Canada. Fraker said that the reason for such initiatives is clear: “Americans save 50-90% on name-brand drugs by personally importing them from certified online Canadian pharmacies.”

The Healthcare Innovation Conference brings together employers from Ohio, Kentucky, and Tennessee to hear strategies that help reduce and control rising healthcare costs.