Customs & FDA Cannot Keep Up With Rx Imports, GAO Warns

OCTOBER 01, 2004
Ken Rankin

Both the FDA and the Department of Homeland Security's US Customs and Border Protection (CBP) are being overwhelmed by the rapidly rising flow of unauthorized imports of prescription drugs from Canada and other countries, a Government Accountability Office (GAO) official warned.

Citing the "growing concern about the safety of the drugs and the lawfulness of shipping the drugs into the United States through international mail and private carriers," the GAO executive told Congress that federal enforcement officials are able to intercept and inspect only a small proportion of these shipments. Because of "resource constraints, many other packages containing prescription drugs are either not inspected and are released to addressees or are released after an inspection," investigators at the agency said.

Although the CBP and the FDA target certain packages for inspection based on the packages' countries of origin and whether the packages are suspected of containing certain prescription drugs, "packages that are not targeted typically bypass inspection and are released to addressees without an assessment of their contents or admissibility," a GAO spokesperson said.

FDA officials have acknowledged that "tens of thousands of packages containing drug products that may violate current laws and pose health risks to consumers have been released," the GAO official added. Although the FDA has begun implementing new procedures to target and interdict shipments of unapproved prescription drugs at mail and private carrier facilities, it is "too soon to tell if these efforts are sufficient to address various health, safety, and law enforcement issues associated with the importation of prescription drugs," according to the agency.

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