We believe that features such as those previously outlined will help assure the safety of imported pharmaceuticals. Any system designed by Congress should also be realistic in terms of its safety requirements and FDA's responsibilities and capacity. This system should not be overly burdensome and costly to the point where American consumers will not be able to realize savings from imported pharmaceuticals. In addition to drug prices, shipping and handling, processing fees, licensure, and other costs should be reasonable and fully disclosed to the consumer at the time of purchase.
Consumer privacy also must be protected. As American consumers are able to purchase prescription drugs from other countries, not only should the integrity of the pharmaceuticals be ensured, but so should the privacy of the individual's protected health information. With the promulgation of the Health Insurance Portability and Accountability Act ("HIPAA") privacy standards, we have moved our nation closer to assuring protection against misuse of an individual's medical information. Studies have shown that individuals will not take advantage of a system if they fear their protected health information may be misused. Therefore, we encourage you as you design an importation system, to ensure that an individual's private medical information is protected at least to the level currently required by HIPAA.
There are additional issues that we urge Congress to consider. There remains a strong need to examine the safety of pharmaceuticals within the United States' drug supply in order to prevent counterfeit, diluted, or ineffective drugs. As Congress examines foreign pharmaceutical supply systems, there is also an opportunity to revisit the integrity of the U.S. pharmaceutical system – from point of manufacture to the ultimate consumer.
Finally, importation legislation undoubtedly will impact the worldwide pharmaceutical market. The FDA should be required to submit reports to Congress, annually or as otherwise appropriate, to monitor the impact of regulated importation on the price, quality, and access to pharmaceuticals both in the U.S. and worldwide.
Our members want Congress to enact legislation this year to allow for legal, safe importation of lower priced prescription drugs. We commend this Committee for its work in moving forward on the issue. We pledge to work with members on both sides of the aisle to develop a system to enable our members – and all Americans – to have secure access to lower cost imported prescription drugs.