The Volume of Prescription Drug Imports Is Unknown but Believed to Be Substantial, and the Safety of These Drug Imports Is Not Assured

My statement will now focus on what the available data show about the  volume and safety of prescription drugs imported into the United States  for personal use through the international mail and private carriers. CBP and FDA Do Not Know the Scope of Prohibited Prescription Drug Importation, but They Believe it to Be Substantial

In our report, we state that CBP and FDA do not systematically collect  data on the volume of prescription drugs and controlled substances they  encounter at the mail and carrier facilities. The Safety of Prescription Drug Imports Is Not Assured

Regarding the safety of prescription drug imports, we report that FDA  officials have said that they cannot provide assurance to the public  regarding the safety and quality of drugs purchased from foreign sources,  which are largely outside of their regulatory system. The results of  these efforts have raised questions about the safety of some of the drugs. New Procedures Should Encourage Uniform Practices, but They Still Allow Many Packages Containing Prescription Drugs to Be Released

With regard to procedures and practices used at selected facilities to  inspect and interdict prescription drugs unapproved for import, our report  cites our July 2004 testimony in which we reported that CBP and FDA  officials at selected mail and carrier facilities used different practices and  procedures to inspect and interdict packages that contain prescription  drugs. Factors beyond Inspection and Interdiction Complicate Efforts to Enforce the Prohibitions on Personal Importation of Prescription Drugs

My statement will now focus on the three factors that our report identified  as affecting federal agency efforts to enforce the prohibition on  prescription drug importation for personal use through international mail  and carrier facilities. Internet Pharmacies Challenge Law Enforcement Efforts

According to our report, Internet pharmacies, particularly foreign-based  sites, which operate outside the U.S. regulatory system, pose a challenge  for regulators and law enforcement agencies. Before any imported item is  refused, the current law requires FDA to notify the owner or consignee  that the item has been held because it appears to be prohibited and give  the product’s owner or consignee an opportunity to submit evidence of  admissibility. As of July 2005, according to FDA officials and an HHS official, the  Secretary had not responded with a specific legislative proposal to change  FDA’s notification requirement. Federal Efforts to Coordinate Law Enforcement Activities Could Benefit from a Strategic Framework

My statement will now focus on efforts federal agencies have undertaken  to coordinate the enforcement of the prohibitions on personal importation  of prescription drugs. CBP officials and other members of the task force provided examples of  activities being carried out or planned by task force working groups. According to our report,  the challenges we identify could be more effectively addressed by using a  strategic framework that more clearly defines the scope of the problem by  estimating the volume of drugs entering international mail and carrier  facilities, establishes milestones and performance measures, determines  resources and investments needed to address the flow of imported drugs  entering the facilities and where those resources and investments should  be targeted, and evaluates progress. CBP and other agencies have taken a step in the right  direction by establishing a task force designed to address many of the  challenges discussed in this report. In addition to the issues  addressed by the task force, FDA has also expressed continuing concern  to Congress that it encounters serious resource constraints enforcing the  law at mail facilities because packages containing personal drug imports  must be handled in accordance with FDA’s time-consuming and resource- intensive notification process. This is a work of the U.S. government and is not subject to copyright protection in the  United States.
Why GAO Did This Study

This testimony summarizes a GAO report on federal efforts to address the importation of prohibited prescription drugs through international mail and carrier facilities for personal use. U.S. Customs and Border Protection (CBP), in the Department of Homeland Security (DHS), and the Food and Drug Administration (FDA), in the Department of Health and Human Services (HHS), work with other federal agencies at international mail and express carrier facilities to inspect for and interdict these drugs. This testimony addresses (1) available data about the volume and safety of these drugs, (2) the procedures and practices used to inspect and interdict them, (3) factors affecting federal efforts to enforce the laws governing these drugs, and (4) federal agencies' efforts to coordinate enforcement of the prohibitions on personal importation of these drugs.

What GAO Found

The information currently available on the safety of illegally imported prescription drugs is very limited, and neither CBP nor FDA systematically collects data on the volume of these imports. Nevertheless, on the basis of their own observations and limited information they collected at some mail and carrier facilities, both CBP and FDA officials said that the volume of prescription drugs imported into the United States is substantial and increasing. FDA officials said that they cannot assure the public of the safety of drugs purchased from foreign sources outside the U.S. regulatory system. FDA has issued new procedures to standardize practices for selecting packages for inspection and making admissibility determinations. While these procedures may encourage uniform practices across mail facilities, packages containing prescription drugs continue to be released to the addressees. CBP has also implemented new procedures to interdict and destroy certain imported controlled substances, such as Valium. CBP officials said the new process is designed to improve their ability to quickly handle packages containing these drugs, but they did not know if the policy had affected overall volume because packages may not always be detected. GAO identified three factors that have complicated federal enforcement of laws prohibiting the personal importation of prescription drugs. First, the volume of imports has strained limited federal resources at mail facilities. Second, Internet pharmacies can operate outside the U.S. regulatory system and evade federal law enforcement actions. Third, current law requires FDA to give addressees of packages containing unapproved imported drugs notice and the opportunity to provide evidence of admissibility regarding their imported items. FDA and HHS have testified before Congress that this process placed a burden on limited resources. In May 2001, FDA proposed to the HHS Secretary that this legal requirement be eliminated, but according to FDA and HHS officials, as of July 2005, the Secretary had not respondedwith a proposal. FDA officials stated that any legislative change might require consideration of such issues as whether to forgo an individual's opportunity to provide evidence of the admissibility of the drug ordered. Prior federal task forces and working groups had taken steps to deal with Internet sales of prescription drugs since 1999, but these efforts did not position federal agencies to successfully address the influx of these drugs imported from foreign sources. Recently, CBP has 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. 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.