Prescription Drugs: Importation for Personal Use

Publication Date: August 2001

Publisher: Library of Congress. Congressional Research Service

Author(s):

Research Area: Health; Trade

Type:

Abstract:

The 107th Congress, concerned about the high costs of pharmaceuticals in the United States, is considering legislation that would give U.S. citizens the legal right to import less costly prescription drugs from foreign countries. The House, in the FY2002 appropriations for the Department of Agriculture (H.R. 2330), adopted an amendment, sponsored by Representative Gutknecht that would let persons, who are not commercial drug importers import prescription drugs for personal use. Under the amendment, drugs must be Food and Drug Administration (FDA) approved, non-narcotic, and manufactured in an FDA-registered facility. In the Senate, a different proposal to allow drug imports (S.1229) was introduced by Senator Wellstone. It would allow patients to import prescription drugs if they are FDA-approved, non-narcotic, made in FDAregistered facilities, originate from specified countries, and are accompanied by a special import form. FDA would have to keep records of the drugs imported.

These proposals would change FDA's current "personal use import policy," which lets patients with lifethreatening conditions (i.e., AIDs or cancer, etc.) bring small quantities of unapproved drugs into this country for personal use, to one that lets patients import approved prescription drugs for personal use. The proposals were introduced when the past and present Secretaries of Health and Human Services (HHS) declined to implement last year's Medicine Equity and Drug Safety Act (MEDS), legislation which would have let pharmacists and drug wholesalers import drugs originally made in the United States. According to the Secretaries, the MEDS Act would have raised health risks and not lowered the cost of prescription drugs. Also, they were worried that the program might make it easier for counterfeit drugs to enter the country.