Medicare Compliance & Reimbursement

Limited data constricts FDA's quality control efforts over unlawful imports.

The volume of prescription drugs illegally imported into the United States is huge--and increasing. Despite the Food and Drug Administration's efforts to encourage mail facilities' practices of detecting and destroying packages that contain illegally imported prescription drugs, many of those packages still make their way into addressees' hands.

The large volume of such packages has "strained limited federal resources" at mail facilities, which has hurt federal enforcement of laws against personal prescription-drug importation into the United States, a Nov. 10 Government Accountability Office report reveals. Making matters worse, the FDA's new procedures to standardize practices for inspecting packages and making "admissibility" determinations have flaws that allow facilities to release packages to addressees, the GAO says.

Under current law, the FDA must notify addressees of packages containing "unapproved imported drugs" and give them "the opportunity to provide evidence of admissibility regarding their imported items," the GAO points out. But this process is an unnecessary burden, the FDA testified before Congress.

The FDA also asked the Department of Health and Human Services  to eliminate this requirement in May 2001, but it had not received a response as of July 2005. HHS should consider changing or eliminating this notification requirement, the GAO recommends. CMS Inspects Drugs In Nursing Homes On the heels of the GAO's report, the Centers for Medicare and Medicaid Services sent a letter to its state survey agency directors, instructing surveyors to scrutinize long-term care facilities that acquire and dispense foreign drugs to patients.

"In our experience, many drugs obtained from foreign sources that purport and appear to be the same as U.S.-approved prescription drugs have been of unknown quality," the agency cautions in the Nov. 14 correspondence.

If an LTC facility acquires and dispenses a foreign drug that doesn't have FDA approval or doesn't comply with the Federal Food, Drug, and Cosmetic Act's labeling requirements, the surveyor should cite the facility for unsafe pharmacy practices and report the finding to the FDA, CMS told surveyors. But determining the legal status of foreign drugs that LTC facilities dispense "can be complicated," because many legal FDA-approved prescription-drug imports come from a legitimate foreign manufacturer or licensed wholesale distributor connected to the manufacturer, the agency admits.