RL31503
Importing Prescription Drugs
July 16, 2002

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Summary:

In recent years, American consumers, particularly the elderly and uninsured, have discovered they often pay a lot more for pharmaceuticals than citizens in other countries. As prescription drug prices continue to rise, more patients are turning to the Internet, or traveling outside the county, to find cheaper prescription drugs. However, under current law only drug companies can import pharmaceuticals into the United States. Despite this legal restriction, the Food and Drug Administration (FDA) has for years allowed patients to bring a 90-day supply of prescription medications into the country under its so-called "personal use" import policy. In an earlier effort to deal with the price disparity issue, the 106th Congress passed the Medicine Equity and Drug Safety (MEDS) Act of 2000, legislation that would have allowed pharmacists and drug wholesalers to import less costly FDAapproved drugs from other countries. However, Congress said the Act could not be implemented unless the Secretary of Health and Human Services (HHS) could first guarantee that all drugs imported under the program would be safe and offer significant cost savings for consumers. In time, both the former and current Secretaries said these conditions could not be met, and refused to implement the law. When the Secretaries decided not to implement the MEDS Act, several bills were introduced in the 107th Congress, each taking a somewhat different approach to the drug import issue. One such proposal, offered by Representative Gutknecht, and passed by the House as an amendment to the FY2002 agriculture appropriations bill, would have let persons import small, non-commercial, amounts of prescription drugs for their own use. However, the amendment was later dropped during conference. Congress is now considering different proposals that would codify FDA's personal use import policy and make it easier for drugs to be imported from outside the country. All of the proposals would let patients bring a 90-day supply of prescription drugs into the country for self-treatment. However, S. 215 (Stabenow) would require these imports to be accompanied by strict "chain of custody" documentation. S. 1229 (Wellstone) would let patients import drugs as long as they were FDA-approved, non-narcotic, and manufactured in registered facilities. Two identical bills, S. 2244 (Dorgan) and H.R. 4614 (Sanders), would waive current prohibitions on drug imports if they are for personal use. Moreover, two of the proposals, S. 215 and S. 2244/H.R. 4614 address the commercial import policy by establishing a program similar to the MEDS Act that would let licensed pharmacists and drug wholesalers import prescription drugs commercially. However, S. 2244/H.R. 4614 would allow drug imports only from Canada. Supporters of these drug import proposals want Congress to enact legislation that would codify FDA's personal use policy and make it easier to import cheaper drugs from outside the country, particularly from Canadian suppliers. Critics, on the other hand, argue that these proposals could weaken existing import laws and make it easier for unsafe or counterfeit drugs to enter the country. While the Dorgan/Sanders bills would mandate authenticity testing to guard against this, the cost of testing would surely be passed on to consumers, and critics question whether there would be a noticeable reduction in the price of prescription drugs.