Seniors Beware: Drug Reimportation is Risky
Friday November 22, 2002
Millions of seniors who depend on costly prescription drugs to stay healthy will go to almost any length to get their medicines, including purchasing them from foreign countries. Recent advertisements in The Sun and in other newspapers throughout the country claim that Congress has legalized drug reimportation. Not true.
Because of rapidly escalating drug costs, many seniors are buying their medicines through web sites offering to "reimport U.S. manufactured drugs" from foreign countries. Pharmaceutical manufacturers sell their products to other countries at much lower prices than in the United States, and even after shipping and a dealer's markup, Americans can pay far less for reimports than at their local pharmacy. However, despite advertising claims to the contrary, the reimportation of drugs is still risky.
In 2000, Congress passed broad reimportation legislation, but the law specified that implementation was contingent upon a finding by the Secretary of Health and Human Services (HHS) that the imports are safe and pose no risk to public health. Both the Clinton Administration Secretary of HHS and the current HHS Secretary Tommy Thompson have stated that they are unable to guarantee the safety of reimported drugs. This year, the Senate passed legislation that would legalize only imports from Canada, with a minimum of oversight from HHS. However, the House failed to act on this proposal.
Regardless, the drug reimportation business is thriving. The practice has become so widespread that many people have asked me about an ad printed in The Sun on April 30, 2002 . For a $6 per prescription, $10 for a list of available drugs, and a $15 shipping and handling fee, the company that placed the ad promised to ship medicines from a Canadian pharmacy at substantial discounts.
Prompted by calls from constituents, I contacted the U.S. Food and Drug Administration (FDA) to inquire about the legality of this practice. The FDA reaffirmed that the reimportation of drugs from foreign sources is illegal and potentially dangerous. The text of my letter and the FDA's response are available on my web site: www.house.gov/cardin/.
The FDA stressed that Americans purchasing reimported drugs have no assurance that such products are safe and effective or that they have been produced under U.S. manufacturing standards. They may have been stored improperly or they may be contaminated, sub-potent, super-potent, or counterfeit. In such cases, consumers would have no protections against poor quality, inaccurate labeling, or phony products. Furthermore, the FDA does not regulate foreign manufacturers, distributors or pharmacies and is not empowered to act on behalf of consumers who have been harmed or cheated by these companies.
Currently more than 90 web sites and other mail-order companies are under review for possible violation of federal law. The FDA has informed the companies selling these drugs over the Internet that they may be engaged in illegal activities. While the FDA has taken some steps to curtail the trade in reimported drugs, it clearly lacks sufficient staff to do an effective job.
America is the world leader in health care quality and innovation, yet many of our seniors surf the Internet and ride buses to Mexico and Canada in search of less expensive drugs. It's time to enact a meaningful, comprehensive Medicare prescription drug benefit; one that provides seniors with affordable medicines and the guarantee of federal safety protections.
