Prescription Drug Import Provisions of the FY2001 Agriculture Appropriations Act, P.L. 106-387

Publication Date: January 2001

Publisher: Library of Congress. Congressional Research Service

Author(s):

Research Area: Health; Trade

Type:

Abstract:

The FY2001 Agricultural Appropriations bill [P.L. 106-387] included two amendments to the Federal Food Drug and Cosmetic Act (FFDCA): one that would have required the Food and Drug Administration (FDA) to establish a 5-year drug import program that would allow pharmacists and wholesalers to import FDA-approved prescription drugs into the United States; and a second that placed conditions on FDA sending warning letters regarding the importation of drugs for personal use.

When the106th Congress was unable to reach a consensus on a new a prescription drug benefit under Medicare, it looked for other ways to increase the availability of lower cost prescription drugs. Under the new law, pharmacists and drug wholesalers who import drugs would have to provide FDA with specific information that would allow the agency to monitor the program. All imported drugs would have to be FDA-approved, tested for authenticity, and be properly labeled before they could be distributed. Drug companies would be prohibited from entering into contracts and agreements that would limit or interfere with the program's implementation.

The import program could not begin until the Secretary of Health and Human Services (HHS) certified to Congress that its implementation would pose no additional public health risk and would significantly reduce the cost of drugs for American consumers. However, on December 26, 2000, Secretary Shalala advised the President that she could not implement the program because of what she termed "serious flaws and loopholes" in the legislation. Nevertheless, the conditions on warning letters are effective immediately. This report will be updated as events warrant.