Importing Prescription Drugs

Publication Date: August 2002

Publisher: Library of Congress. Congressional Research Service

Author(s):

Research Area: Health; Trade

Type:

Abstract:

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. Under current law, however, 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 2000, the 106th Congress passed the Medicine Equity and Drug Safety (MEDS) Act, legislation that would have allowed pharmacists and drug wholesalers to import less costly FDA-approved drugs from other countries. However, Congress stipulated that 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 declined to implement the law.

Congress is considering several ways to increase the supply of less costly prescription drugs for consumers, in particular codifying FDA's "personal use" import policy, and creating a program that would let pharmacists and drug wholesalers import drugs commercially. On July 31, 2002, the Senate passed the Greater Access to Affordable Pharmaceuticals Act (S. 812), legislation to speed-up the approval of less costly generic drugs. The bill included the text of the Prescription Drug Price Parity for Americans Act (S. 2244), an amendment offered by Senator Dorgan, that would allow people to bring a 90-day supply of prescription drugs into the country for personal use from registered Canadian pharmacies, and simultaneously create a commercial import program, similar to the MEDS Act, that would let licensed pharmacists and drug wholesalers import FDA-approved prescription drugs from Canada. The Senate also agreed to an amendment sponsored by Senator Cochran that would require the Secretary of HHS to first certify to Congress that all imported drugs would be safe and offer significant cost savings for consumers, the same two contingencies that kept the MEDS Act from being implemented in 2000. H.R. 4614, a bill similar to the Dorgan amendment is currently pending in the House.

Supporters of the various drug import proposals are urging Congress to pass legislation that will codify FDA's personal use import policy, making it easier for patients to bring cheaper prescription drugs into the country, and at the same time establish a program allowing pharmacists and drug wholesalers to import drugs commercially from Canada. Opponents, 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 safeguard against this, the cost of testing would likely be passed on to consumers, and critics question whether there would be a noticeable reduction in the price of prescription drugs.