GAO urges more be done to stop illegal prescription drug imports
A congressional watchdog agency said federal regulators must do more to stop the flow of illegal prescription drugs entering the United States.
A Government Accountability Office study released this week found that federal regulators, namely Customs and Border Protection and the Food and Drug Administration, lack sufficient information on the safety and volumes of prescription drugs entering the country through mail and carrier facilities.
The GAO study noted that the volume of imports has “strained limited federal resources” at mail facilities. The study also found that Internet pharmacies can operate outside of the U.S. regulatory system and avoid federal law enforcement.
Another setback to federal controls is the requirement for FDA to give addressees of packages containing unapproved imported drugs notice and the opportunity to provide evidence of admissibility regarding their imported items. FDA officials have repeatedly told Congress and Bush administration officials that this requirement should be abolished to sharpen its enforcement capabilities.
To counter illegal prescription drug imports, the FDA issued new procedures to standardize practices for selecting packages for inspection and making admissibility decisions.
CBP implemented new procedures of its own to interdict and destroy certain imported controlled substances, such as Valium. But under both procedures, it’s uncertain how many prescription drug imports slip through untouched.
CBP recently organized a task force to coordinate federal agencies’ activities to enforce the laws prohibiting the personal importation of prescription drugs.
“The task force’s efforts appear to be steps in the right direction, but they could be enhanced by establishing a strategic framework to define the scope of the problem at mail and carrier facilities, determine resource needs, establish performance measures, and evaluate progress,” the GAO said. “Absent this framework, it will be difficult to oversee task force efforts; hold agencies accountable; and ensure ongoing, focused attention to the enforcement of the relevant laws.”