In recent years, as prices of prescription drugs have risen, many in Congress have sponsoredlegislation to permit the importation of Food and Drug Administration (FDA) approved drugs fromless expensive foreign sources. In the 109th Congress, three pairs of bills have been introduced torepeal the existing import restrictions and provide for limited forms of importation of prescriptiondrugs. 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 andeffective. An underlying goal is to reduce or restrain the growth of the financial burden thatprescription drugs place on U.S. consumers. Current law bars importation unless the Secretary of Health and Human Services (HHS)certifies that imports are safe and offers cost savings to U.S. consumers. Congress reaffirmed thisrequirement, first established by the Medicine Equity and Drug Safety (MEDS) Act of 2000, mostrecently in the Medicare Prescription Drug, Improvement, and Modernization Act (MMA, P.L.108-173 ) in December 2003. The three bill pairs each would eliminate this requirement and, instead,include other potential safeguards regarding drug safety and effectiveness. They all would actprimarily by replacing or amending Section 804 of the Federal Food, Drug, and Cosmetic Act(FFDCA), which had been initially added to the FFDCA by the Medicine Equity and Drug Safety(MEDS) Act of 2000; individual bills would amend other laws. This report compares the provisions of three approaches to prescription drug importation(represented by three Senate and three House bills) with provisions on the subject in currentlaw. (1) The three bill pairsare: The Pharmaceutical Market Access Act of 2005 : S. 109 ,introduced by Senator Vitter on January 24, 2005, and H.R. 328 , introduced byRepresentative Gutknecht on January 25, 2005; referred to in this report as the Vitter-Gutknechtbills. No action has been taken. The Safe Importation of Medical Products and Other Rx Therapies Actof 2005, or the Safe IMPORT Act of 2005 : S. 184 , introduced by Senator Gregg onJanuary 26, 2005, and H.R. 753 , introduced by Representative Bradley on February10, 2005; referred to in this report as the Gregg-Bradley bills. No action has beentaken. The Pharmaceutical Market Access and Drug Safety Act of 2005 : S. 334 , introduced by Senator Dorgan on February 9, 2005, and H.R. 700 , introduced the same day by Representative Emerson; referred to in this report as theDorgan-Emerson bills. In July 2005, Senator Dorgan successfully offered the drug importationprovisions as an amendment to the Federal Trade Commission reauthorization bill ( S. 1392 ) ordered to be reported by the Senate Commerce, Science and Transportation Committee. (2) The differences in approach across the bills fall into three areas: attempts to ensure thatimported drugs are safe and effective; attempts to influence industry behavior so drugs are availablefor import by U.S. consumers at cost savings to current domestic prices; and administrativearrangements. Current law and language proposed by the Vitter-Gutknecht and Gregg-Bradley billsexplicitly require that an imported drug be approved for U.S. sale by the FDA. The Dorgan-Emersonbills would allow different administrative requirements for importation while maintaining thesubstantive elements of FDA approval. The Dorgan-Emerson bills require that a manufacturer notifythe HHS Secretary when a drug that could be imported differs from the version FDA had approvedfor sale in the United States (the "U.S. label drug"). The bills require extensive information aboutwhether the difference, if it were to be made to a U.S. label drug, would require a supplementalapplication to FDA and whether FDA would require that the application be processed before thedrug could be marketed. The three bills and current law vary in the countries from which they would permit drugimportation. The most inclusive are the Vitter-Gutknecht bills, (3) which include Australia,Canada, Israel, Japan, New Zealand, Switzerland, South Africa, members of the European Union,Iceland, Liechtenstein, and Norway. These bills also would allow the Secretary to designateadditional countries that have equivalent regulatory requirements regarding safety and effectiveness,or to remove a country that does not. The Dorgan-Emerson bills differ from the Vitter-Gutknechtbills by excluding Israel, South Africa, and members of the European Economic Area that are notalso members of the European Union (excluded are Iceland, Liechtenstein, and Norway), and, forEuropean Union countries, by adding a reference to their Annex to the Treaty of Accession thatessentially disqualifies the 10 countries admitted to membership in May 2004 (excluded are Cyprus,the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia, and the SlovakRepublic). The Gregg-Bradley bills would include Canada and allow the Secretary, three years afterenactment, to designate as eligible any members of the European Union as of December 2003. Current law includes only Canada, although it allows the Secretary to grant waivers permittingpersonal-use importation from other countries. Sponsors of all three pairs of bills are concerned about the potential for entry of adulteratedor counterfeit drugs into the U.S. market. Consequently, they call for a variety of procedurescovering the registration of exporters or importers; chain-of-custody documentation; inspections ofmanufacturing, storage, and shipping facilities; laboratory testing of drug samples; packaging; andlabeling of shipping containers and consumer products. Registration. Current law requires that aCanadian establishment involved in importing prescription drugs to the United States register itsname and place of business and the name of its U.S. agent with the Secretary. All three bills haveextensive registration requirements. The specifics vary and cover extensive recordkeeping,monitoring, inspections, and fees. The Vitter-Gutknecht bills would require all exporters to register;the Gregg-Bradley and Dorgan-Emerson bills require all exporters and all commercial importers toregister. Monitoring, Inspecting, and Testing. Whilecurrent law relies on laboratory testing of samples of every shipment of imported drugs to verify theircontent, potency, and labeling, the three proposed bills focus on documentation of a monitored,uninterrupted chain of custody from manufacturing facility to importer. The requirements relatedto registration involve ongoing and onsite physical monitoring of the facilities of a drug'smanufacturer, exporter, or importer. If the Secretary determines it necessary, these would includethe inspection of any facility (and its records) that handles the product along the chain of custody. Packaging and Labeling. In addressingcounterfeiting and product tampering, all three bills promote measures intended to ensure that thedrug dispensed to the individual consumer is the same product that was tested, monitored, orinspected at the manufacturing, shipping, or storage facility. The Vitter-Gutknecht bills wouldrequire that the packaging of all prescription drugs (not just those being imported) incorporate overtoptically variable counterfeit-resistant technologies that provide visible identification of the product,and be similar to those used to secure U.S. currency. In addition, manufacturers must incorporatethe technologies into multiple elements of the packaging (including blister packs, shrink wrap,package labels, package seals, bottles, and boxes). Also, shipping containers of prescription drugsmust have labels that incorporate technologies that enable inspectors to verify the authenticity of theshipment. The Gregg-Bradley bills would direct the Secretary to require the use of electronictrack-and-trace technology at the case and pallet level that would identify each sale, purchase, ortrade of each case or pallet. The Dorgan-Emerson bills require that the exporter and importer agreeto mark each shipping container to identify its compliance with all registration conditions. Themarkings must include anti-counterfeiting or track-and-trace technology, taking into account theireconomic and technical feasibility, and must be designed to prevent unauthorized affixation. Internet Pharmacies. Current law does notaddress use of the Internet to sell or purchase imported prescription drugs. The Vitter-Gutknechtbills have no provisions specifically related to Internet pharmacy procedures, but include qualifiedInternet pharmacies among other registered exporters and the extensive associated requirements. The Gregg-Bradley and Dorgan-Emerson bills do address Internet sales. Their provisions addressregistration, posted information, prescriptions, and relationship to medical care. The Gregg-Bradley bills present an extensive statutory and regulatory structure for Internetpharmacies, placing it in the FFDCA but set apart from the importation sections. In addition toregistration, the bills would require that Internet pharmacies provide specific professional services,including confidential patient medication profiles, "interactive and meaningful consultation by alicensed pharmacist," and verification of prescription validity. They require advance notice ofcommercial shipments of prescription drugs and include a licensing fee. Providers of interactivecomputer services would be liable if they accept advertising for a prescription drug from anunlicensed Internet pharmacy or accept advertising stating that a physician's prescription is notneeded to obtain a prescription drug. The Gregg-Bradley bills also require policies and proceduresto prevent payments for unlawful Internet pharmacy requests. The Dorgan-Emerson bills would require that detailed information be accessible on theInternet site, covering pharmacist credentials, address and telephone contacts, and the name andprofessional licensure information of the person, if any, who provides for medical consultationsthrough the site for purposes of providing prescriptions.