This product information is intended only for residents of the United States.
Prescription drug importation occurs when foreign pharmacies and traders ship medicines, which may or may not be approved for use in other countries, into the U.S. for sale to American consumers. The World Health Organization estimates that more than 50% of prescription medicines that are bought from Internet sites that conceal their physical address are counterfeit,1,2 yet some Members of Congress are considering legislation to allow U.S. consumers to import medicines from countries where they may be cheaper, even though American regulatory controls to ensure that medicines are safe and genuine cannot be imposed on foreign businesses.
Under current law, an individual can import up to a 90-day supply of prescription drugs from Canada for personal use. Large volume importation of prescription drugs could be permitted under current law only if the Health and Human Services (HHS) Secretary was willing to certify that imported drugs "pose no additional risk to the public's health and safety, and result in a significant reduction in the cost of covered products to the American consumer." Recent HHS Secretaries, such as Donna Shalala, Tommy Thompson, and Michael Leavitt, have not been willing to make this certification of "no risk".
Prescription drug importation raises serious safety concerns due to the difficult task of closely tracking drugs exported to the U.S. to ensure safe handling and to prevent damaged and/or counterfeit (i.e. fake) drugs from being imported into the U.S. and sold to Americans.
The U.S. Food and Drug Administration (FDA), the Drug Enforcement Agency, and the U.S. Customs Service believe that lowering drug importation standards to allow large volume importation could be dangerous and pose an increased risk to public health. In fact, the leading drug safety experts at the FDA agree that drug importation creates an unacceptable risk to the U.S. public. Ten former FDA Commissioners published letters in 2001 stating these opinions.
In addition to the serious safety risks of drug importation, the Health and Human Services (HHS) and the Office of Management and Budget (OMB) have stated that prescription drug importation would not result in significant savings for consumers. The HHS Task Force on Drug Importation estimates that administrative costs of a government importation program could reach $3 billion annually and may even result in a net cost for importing drugs instead of providing any savings.3
The success of the Medicare Part D prescription drug benefit is a major reason for the diminished interest by consumers and state governments in drug importation programs. These programs have not succeeded because consumers have largely been well served by Medicare Part D and other patient assistance programs, such as the pharmaceutical industry's Partnership for Prescription Assistance, which are helping eligible Americans get the medicines they need every day. In spite of this, importation continues to receive attention in Congress and in the media.
Despite safety concerns and official estimates of little or no savings from a drug importation program, legislation is repeatedly introduced in Congress that would allow commercial importation. For example, on January 10, 2007, Senator Dorgan introduced his latest drug importation bill (S. 242) called the "Pharmaceutical Market Access and Drug Safety Act of 2007".2 The bill would permit drug importation from Canada, Australia, New Zealand, Japan, Switzerland, and some members of the European Union. One of the key safety concerns with the legislation is that commercial drug importation could be extended to other countries without consideration of the prevalence of counterfeit drugs in their supply chain. Additionally, the bill does not include a meaningful mechanism to track the chain of custody of the imported drugs that would provide for appropriate regulation and ensure drug safety.
Additional importation legislation includes a bill passed by Congress in October 2000 called the Medicine Equity and Drug Safety Act. This Act could not be implemented due to public safety concerns. The then-Secretary of HHS, Donna Shalala, determined that HHS could not implement the importation program because neither the safety nor the cost-effectiveness of the Act could be ensured. In July 2001, the then-Secretary of HHS, Tommy Thompson, reached the same conclusion. As a result of these concerns, the federal government did not implement the potentially dangerous legislation.
Over the past decade, a number of bills have been introduced in Congress that would allow commercial drug importation. However no commercial drug importation program has ever been implemented due to serious safety concerns, projected high regulatory costs, and low estimated savings for consumers.
1World Health Organization Counterfeit Medicines Fact Sheet: http://www.who.int/mediacentre/factsheets/fs275/en/index.html
2World Health Organization Report: Combating Counterfeit Drugs: A Concept Paper for Effective International Cooperation. January, 2007. http://www.who.int/medicines/events/FINALBACKPAPER.pdf
3Policy Implications of Importing Drugs into the United States. Statement of Randell Lutter before the United States Senate. March 2007. http://www.fda.gov/NewsEvents/Testimony/ucm109890.htm
4Pharmaceutical Market Access and Drug Safety Act of 2007, bill (S.242) http://www.govtrack.us/congress/bills/110/s242/text