{ "id": "RL32568", "type": "CRS Report", "typeId": "REPORTS", "number": "RL32568", "active": false, "source": "EveryCRSReport.com", "versions": [ { "source": "EveryCRSReport.com", "id": 100138, "date": "2004-09-07", "retrieved": "2016-04-07T20:09:27.922485", "title": "Senate Prescription Drug Importation Legislation: A Side-by-Side Comparison of Current Law, S. 2307, S. 2328, and S. 2493", "summary": "Senators Grassley, Dorgan, and Gregg have each introduced bills that address Congressional\nconcerns with prescription drug importation that were not resolved by the provisions in the Medicare\nPrescription Drug, Improvement, and Modernization Act (the MMA, P.L. 108-173 ).\n S. 2307 , the Reliable Entry for Medicines at Everyday Discounts\nthrough Importation with Effective Safeguards Act of 2004, introduced by Senator Grassley on April\n8, 2004 [the Grassley bill]; \n S. 2328 , the Pharmaceutical Market Access and Drug Safety Act\nof 2004, introduced by Senator Dorgan on April 21, 2004 [the Dorgan bill];\nand \n S. 2493 , the Safe Importation of Medical Products and Other Rx\nTherapies Act of 2004, introduced by Senator Gregg on June 2, 2004 [the Gregg\nbill]. \n By continuing the major legal obstacle to importation -- the requirement that the Secretary of\nHealth and Human Services first certify that imports are safe and offer cost savings to U.S.\nconsumers, something no Secretary has been willing to do -- the MMA effectively does not allow\nthe commercial or personal-use importation of prescription drugs. This report briefly discusses\nmajor differences among current law and the bills introduced in April and June 2004 and presents\na side-by-side comparison of the provisions.\n Although all three bills seek to make lower-priced prescription drugs available to U.S.\nconsumers by allowing importation while also ensuring that the drugs are safe and effective, they\ntake different approaches. The three Senate bills use extensive registration, licensing, facility\ninspection, and records requirements to document an imported shipment's chain-of-custody\nrequirements rather than the MMA's mandated laboratory testing of imported drugs to verify their\ncontent, potency, and labeling. Current law and the bills each have different lists of countries from\nwhich imports could be imported, and they provide the Secretary with different time frames and\ncriteria for determining whether to permit commercial or personal-use importation. Secretarial\nreporting requirements vary as do mechanisms to fund the import activities: the MMA relies on\nappropriations, and the Senate bills each create specific user fee provisions. Only the Gregg bill\nrequires the regulation of Internet pharmacies. The Grassley and Dorgan bills propose links to\nantitrust, patent, and internal revenue titles of the U.S. Code to influence industry behavior. The\nMMA does not specify when importation could begin. For commercial imports from Canada, the\nGrassley and Dorgan bills start 90 days from enactment, later for other countries; the Gregg bill\nallows imports from Canada only, beginning one year from enactment. The Grassley and Gregg bills\nallow personal-use imports from Canada upon enactment, with the Grassley bill's allowing other\ncountries later; the Dorgan bill allows personal-use imports from Canada only, beginning 90 days\nafter enactment.", "type": "CRS Report", "typeId": "REPORTS", "active": false, "formats": [ { "format": "PDF", "encoding": null, "url": "http://www.crs.gov/Reports/pdf/RL32568", "sha1": "d1c5d105a17d0933e0e96bc5fa3de03d2cd5753e", "filename": "files/20040907_RL32568_d1c5d105a17d0933e0e96bc5fa3de03d2cd5753e.pdf", "images": null }, { "format": "HTML", "filename": "files/20040907_RL32568_d1c5d105a17d0933e0e96bc5fa3de03d2cd5753e.html" } ], "topics": [] } ], "topics": [ "Appropriations", "Domestic Social Policy", "Health Policy" ] }