	Introduction

The new Medicare legislation, the Medicare Prescription Drug, Improvement, andModernization Act ( P.L. 108-173 ), addresses the importation of prescription drugs for all U.S.consumers, not just for Medicare-eligible individuals. (1) These provisions are rooted in consumer and congressional concernwith the high cost of prescription drugs in the United States. International comparisons of drugprices have confirmed that American consumers, particularly the elderly and uninsured, often paymore for prescription drugs than do citizens in other countries. (2) The importation oflower-priced prescription drugs is one strategy to reduce U.S. consumer spending. The new Act, despite being structured as a replacement to the importation provisions in theMedicine Equity and Drug Safety (MEDS) Act of 2000, does not effectively change U.S.prescription drug importation policy. The details it adds will not be implemented unless theSecretary of Health and Human Services (hereafter referred to as the Secretary) certifies to Congressthat such imports would not threaten the health and safety of the American public and would providecost savings. That certification requirement, continued from prior law, has effectively haltedimplementation of import provisions because no Secretary has been willing to provide the requiredcertification, a stance outlined in testimony from the Food and Drug Administration (FDA). The first deals with drugs from Canada. Commencement of Program. The law does notallow an individual to import a drug for personal use. Study and Report on Importation of Drugs. (17) FDAcontinues to object to these websites and states in a letter to Governor Pawlenty ofMinnesota that the states could face tort liability suits and charges of assisting incriminal activity if citizens suffer injury from these drugs. (18) 

		Congress

Following passage of the Medicare bill, some Members have introduced billsthat seek to allow the importation of prescription drugs. Senator Kennedy introduced S. 1992 on December 9, 2003, one sectionof which would amend the new law's importation provisions to include registration,inspection, and reporting requirements for Canadian wholesalers and pharmacistswho export prescription drugs to the United States; restore the prohibition ofmanufacturer discrimination against importers provisions from the MEDS Act;replace the report requirements now assigned to the Secretaries of HHS andCommerce with reports involving the Institute of Medicine and the GeneralAccounting Office; and remove the requirement that the Secretary certify safety andreduced cost to U.S. consumers before implementing the importation provisions.
The new Medicare legislation, the Medicare Prescription Drug, Improvement, andModernization Act ( P.L. 108-173 ), addresses the importation of prescription drugs for all U.S.consumers, not just for Medicare-eligible individuals. These provisions are rooted in consumer andcongressional concern with the high cost of prescription drugs in the United States. Internationalcomparisons of drug prices have confirmed that American consumers, particularly the elderly anduninsured, often pay more for prescription drugs than do citizens in other countries. The importationof lower-priced prescription drugs is one strategy to reduce U.S. consumer spending.
The new Act, despite being structured as a replacement to the importation provisions in theMedicine Equity and Drug Safety (MEDS) Act of 2000, does not effectively change U.S.prescription drug importation policy. The details it adds will not be implemented unless theSecretary of Health and Human Services (hereafter referred to as the Secretary) certifies to Congressthat such imports do not threaten the health and safety of the American public and do provide costsavings. That certification requirement, continued from prior law, has effectively haltedimplementation of existing import provisions because no Secretary has been willing to provide therequired certification.
The Act changes the law in four basic ways: it (1) directs the Secretary to allow imports fromCanada only (the MEDS Act had allowed imports from a specific list of industrialized countries,including Canada); (2) includes a shift in approach to the importation of prescription drugs byindividuals, by codifying the discretion in enforcement that the Food and Drug Administration(FDA) has exercised to allow the "personal use" imports of prescription drugs; (3) eliminates theprohibition against a manufacturer's entering into agreements to prevent the sale or distribution ofimported products; and (4) includes a mechanism, based on evidence, by which the Secretary canterminate the import program.
Following enactment of the Medicare bill in December 2003, some Members of Congresshave moved to amend the importation of prescription drugs provisions. Some states and localitieshave set up websites to facilitate individuals' purchase of prescription drugs from Canadianpharmacies. FDA has responded. In letters to state officials, FDA has warned that states could facetort liability suits and charges of assisting in criminal activity if citizens suffer injury from thesedrugs. FDA, via the Department of Justice, has gone to the courts to stop the Canadian and U.S.distributors of drugs imported from Canada.