Importing Prescription Drugs Comparison of the Drug Import Provisions in the Medicare Reform Bills, H.R. 2427, and Current Law

Publication Date: October 2003

Publisher: Library of Congress. Congressional Research Service

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Research Area: Health

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Abstract:

For years now, Congress has been concerned about the rising cost of prescription drugs in the United States. Recent international price comparisons have confirmed that American consumers, particularly the elderly and uninsured, often pay much more for pharmaceuticals than do citizens in other countries. As drug prices continue to rise, more people and some local governments are turning to online pharmacies or traveling outside the country to purchase less costly prescription drugs. However, under U.S. law only drug manufacturers 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, Congress passed the Medicine Equity and Drug Safety (MEDS) Act that would have let pharmacists and drug wholesalers import less costly FDAapproved prescription drugs from foreign countries. However, the Act included a controversial provision barring the Secretary of Health and Human Services (HHS) from implementing the law without first confirming that the drugs imported under the program would "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." Since then, two Secretaries have declined to implement the law, stating that these conditions could not be met.

The 108th Congress is focusing now on several new proposals that may make it easier for consumers to access cheaper prescription drugs. In June 2003, the House and Senate agreed to amendments on their respective Medicare reform bills (H.R. 1 and S. 1) that would modify the MEDS Act and make it easier for pharmacists and wholesalers to import less costly prescription drugs from Canada. The bills would also prescribe conditions under which the Secretary could allow imports of drugs for personal use. In separate action, the House passed the Pharmaceutical Market Access Act of 2003 (H.R. 2427), a measure sponsored by Representative Gil Gutknecht that would permit pharmacists, wholesalers and qualifying individuals to import prescription drugs from 25 industrialized countries, and require drug companies to incorporate various tamper-resistant technologies in all prescription drug packaging. Both Medicare reform bills would require prior HHS certification of safety and cost savings; however, H.R. 2427 includes no such mandate.

Supporters of drug importation are urging Congress to pass legislation to allow pharmacists and wholesalers to import prescription drugs commercially, and to allow consumers to bring cheaper prescription drugs into the country. Opponents insist these proposals would weaken existing import laws and make it easier for unsafe or counterfeit drugs to enter the country. Other concerns involve FDA's ability to devise and enforce regulations, the added costs, the feasibility of imports as a longterm solution to high domestic prices, and possible effects on future pharmaceutical research and development. This report will be updated as events warrant.