Ted Sullivan Provides Perspective on Cross-Border Rules for Personal Drug Imports in POLITICO Pro Article
Ted Sullivan, a Quarles & Brady Health & Life Sciences partner in the firm’s Washington, D.C., office, was quoted in a POLITICO Pro article about the delay and potential implications of new customs procedures affecting personal prescription-drug imports.
U.S. Customs and Border Protection delayed implementation of the new requirements from October 22 until January 20. The rules require certain international packages valued at $800 or less to be logged in the agency’s digital processing system. Patient advocates have raised concerns that, once implemented, the changes could disrupt shipments from Canadian pharmacies that some Americans use to obtain lower-cost prescription drugs.
The article also examined how the new requirements could intersect with the Food and Drug Administration’s (FDA) existing approach to personal drug imports. While importing unapproved or foreign prescription drugs generally is illegal, the FDA has historically focused its enforcement efforts on commercial shipments rather than certain shipments clearly intended for personal use.
Sullivan explained that the agency’s policy was designed to address limited circumstances, such as when patients begin treatment overseas and need foreign medicine shipped to the United States to continue that treatment, rather than provide a broader alternative for obtaining less expensive medications from abroad.
An excerpt:
Still, the FDA says its current personal importation policy “should not be interpreted as a license to individuals to bring in such shipments.” Ted Sullivan, an attorney at Quarles and Brady focused on FDA issues, said the agency manual outlines examples of patients who began treatment overseas and require foreign medicines to be shipped to them to continue their therapy.
“This has never been intended to be an alternative import source for drugs, just because it's more expensive in the U.S.,” he said.