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

Pharmacy Times, Volume 0, 0

Both the FDA and the Departmentof Homeland Security's US Customsand Border Protection (CBP) are beingoverwhelmed by the rapidly risingflow of unauthorized imports of prescriptiondrugs from Canada and othercountries, a Government AccountabilityOffice (GAO) official warned.

Citing the "growing concern aboutthe safety of the drugs and the lawfulnessof shipping the drugs into theUnited States through internationalmail and private carriers," the GAOexecutive told Congress that federalenforcement officials are able to interceptand inspect only a small proportionof these shipments. Because of"resource constraints, many otherpackages containing prescription drugsare either not inspected and arereleased to addressees or are releasedafter an inspection," investigators atthe agency said.

Although the CBP and the FDA targetcertain packages for inspectionbased on the packages' countries of originand whether the packages are suspectedof containing certain prescriptiondrugs, "packages that are nottargeted typically bypass inspection andare released to addressees without anassessment of their contents or admissibility,"a GAO spokesperson said.

FDA officials have acknowledgedthat "tens of thousands of packagescontaining drug products that mayviolate current laws and pose healthrisks to consumers have been released,"the GAO official added.Although the FDA has begun implementingnew procedures to target andinterdict shipments of unapprovedprescription drugs at mail and privatecarrier facilities, it is "too soon to tell ifthese efforts are sufficient to addressvarious health, safety, and law enforcementissues associated with the importationof prescription drugs," accordingto the agency.