Importation of Prescription Drugs: A Side-by-Side Comparison of Current Law, S. 109/H.R. 328, S. 184/H.R. 753, and S. 334/H.R. 700

Publication Date: December 2005

Publisher: Library of Congress. Congressional Research Service

Author(s):

Research Area: Health; Trade

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Abstract:

As prices of prescription drugs have risen, many in Congress have sponsored legislation to permit the importation of FDA-approved drugs from less expensive foreign sources. In the 109th Congress, three pairs of bills have been introduced to repeal the existing import restrictions and provide for limited forms of importation of prescription drugs. Current law and the bills all seek to balance the availability of imported prescription drugs -- both for commercial and personal use -- and the assurance that those imports would be safe and effective. An underlying goal is to reduce or restrain the growth of the financial burden that prescription drugs place on U.S. consumers.

The drug importation provisions in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA, P.L. 108-173) effectively do not allow the commercial or personal-use importation of prescription drugs. Congress, with the MMA, continued the major legal obstacle to importation: the requirement that the Secretary of Health and Human Services first certify that imports are safe and offer cost savings to U.S. consumers -- something no Secretary has been willing to do. This report, which will be updated, briefly discusses major differences among current law and the introduced bills, and presents a side-by-side comparison of their provisions. The bills are the Pharmaceutical Market Access Act of 2005 (S. 109, H.R. 328), the Safe Importation of Medical Products and Other Rx Therapies Act of 2005 (the Safe IMPORT Act of 2005; S. 184, H.R. 753), and the Pharmaceutical Market Access and Drug Safety Act of 2005 (S. 334, H.R. 700).

Although all three pairs of bills seek to make lower-priced prescription drugs available to U.S. consumers by allowing importation while also ensuring that the drugs are safe and effective, they take different approaches. The proposed bills use extensive registration, licensing, facility inspection, and records requirements to document an imported shipment's chain-of-custody requirements, rather than the MMA's use of mandated laboratory testing of imported drugs to verify their content, potency, and labeling. Current law and the bills each have different lists of countries from which imports could be imported, and they provide the Secretary with different time frames and criteria for determining whether to permit commercial or personaluse importation. Secretarial reporting requirements vary as do mechanisms to fund the import activities: current law relies on appropriations alone, while the proposed bills each create specific user-fee provisions. The proposed bills also address the regulation of Internet pharmacies. S. 109/H.R. 328 and S. 334/H.R. 700 propose links to patent law to influence industry behavior. While current law does not specify when importation could begin, S. 109/H.R. 328 requires regulations to allow personal-use and commercial imports 180 days after enactment. S. 184/H.R. 753 provides for personal-use imports at enactment and commercial imports one year later. S. 334/H.R. 7000 begins imports from registered exporters 90 days after enactment and by registered importers one year after enactment.