H.H.S. report on drug importation concludes that there are significant risks associated with importing drugs for personal use.

U.S. Drug Regulation System

The current system of drug regulation in the U.S. has been very effective in protecting public safety, but is facing new threats. It should be modified only with great care to ensure continued high standards of safety and effectiveness of the U.S. drug supply.

Risks with the current Importation System

There are significant risks associated with the way individuals are currently importing drugs. Many transactions are occurring via poorly-regulated and occasionally bogus internet operations that in some cases have been documented to provide consumers with inferior products that are not the same as U.S.-approved versions.

Treatment Failures

Treatment failures, which are not obvious adverse events, are a real concern with sub-standard drug products.

Safety of “Personal” Importation

It would be extraordinarily difficult and costly for “personal” importation to be implemented in a way that ensures the safety and effectiveness of the imported drugs. American consumers making individual purchases from foreign sources outside America’s regulatory system, face safety hazards that would be extraordinarily difficult to effectively address and prevent.

Costs and Additional Authorities will be Required

Overall national savings from legalized commercial importation will likely be a small percentage of total drug spending. Developing and implementing such a program would incur significant costs and require significant additional authorities. In order to ensure that imported drugs are safe and effective, additional safety protections would need to be added that would increase the costs of the program in an additive way.

Inspection Requirements

Substantial resources would also be needed to ensure adequate inspection of imported drug products. These increased regulatory and program costs will impact potential savings to consumers.

Imported drugs not always cheaper

The public expectation that most imported drugs are less expensive than American drugs is not generally true. Generic drugs account for most prescription drugs used in the U.S. and are usually less expensive in the U.S. than abroad.

Impact on future drug development

Legalized importation will likely adversely affect the future development of new drugs for American consumers. The report estimates that R&D incentives will be lowered, resulting in roughly between four and eighteen fewer new drugs introduced per decade.

Importation will affect intellectual property rights.

The effects of legalized importation on intellectual property rights are uncertain but likely to be significant. A host of legal and constitutional challenges are probable and the effects on enforcement of intellectual property rights and on agreements with foreign countries are likely to be problematic.

Liability Concerns

Legalized importation raises liability concerns for consumers, manufacturers, distributors, pharmacies, and other entities. Consumers harmed by imported drugs may not have legal recourse against foreign pharmacies, distributors, or other suppliers. Entities in the pharmaceutical supply chain may take actions to protect themselves from liability that could ultimately raise the cost of drugs.