{
  "id": "RL33175",
  "type": "CRS Report",
  "typeId": "REPORTS",
  "number": "RL33175",
  "active": false,
  "source": "EveryCRSReport.com",
  "versions": [
    {
      "source": "EveryCRSReport.com",
      "id": 310717,
      "date": "2005-12-06",
      "retrieved": "2016-04-07T19:25:44.812029",
      "title": "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",
      "summary": "As prices of prescription drugs have risen, many in Congress have sponsored legislation to\npermit\nthe importation of FDA-approved drugs from less expensive foreign sources. In the 109th Congress,\nthree pairs of bills have been introduced to repeal the existing import restrictions and provide for\nlimited forms of importation of prescription drugs. Current law and the bills all seek to balance the\navailability of imported prescription drugs -- both for commercial and personal use -- and the\nassurance that those imports would be safe and effective. An underlying goal is to reduce or restrain\nthe growth of the financial burden that prescription drugs place on U.S. consumers.\n The drug importation provisions in the Medicare Prescription Drug, Improvement, and\nModernization Act of 2003 (MMA,  P.L. 108-173 ) effectively do not allow the commercial or\npersonal-use importation of prescription drugs. Congress, with the MMA, continued the major legal\nobstacle to importation: the requirement that the Secretary of Health and Human Services first\ncertify that imports are safe and offer cost savings to U.S. consumers -- something no Secretary has\nbeen willing to do. This report, which will be updated, briefly discusses major differences among\ncurrent law and the introduced bills, and presents a side-by-side comparison of their provisions. The\nbills are the Pharmaceutical Market Access Act of 2005 ( S. 109 ,  H.R. 328 ),\nthe Safe Importation of Medical Products and Other Rx Therapies Act of 2005 (the Safe IMPORT\nAct of 2005;  S. 184 ,  H.R. 753 ), and the Pharmaceutical Market Access and\nDrug Safety Act of 2005 ( S. 334 ,  H.R. 700 ).\n Although all three pairs of 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 proposed 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 use of mandated laboratory testing of imported drugs to verify\ntheir content, potency, and labeling. Current law and the bills each have different lists of countries\nfrom which imports could be imported, and they provide the Secretary with different time frames\nand criteria for determining whether to permit commercial or personal-use importation. Secretarial\nreporting requirements vary as do mechanisms to fund the import activities: current law relies on\nappropriations alone, while the proposed bills each create specific user-fee provisions. The proposed\nbills also address the regulation of Internet pharmacies.  S. 109 / H.R. 328 \nand  S. 334 / H.R. 700  propose links to patent law to influence industry\nbehavior. While current law does not specify when importation could begin, S.  109/H.R.\n 328 requires regulations to allow personal-use and commercial imports 180 days after\nenactment.  S. 184 / H.R. 753  provides for personal-use imports at\nenactment and commercial imports one year later. S.  334/ H.R. 7000  begins\nimports from registered exporters 90 days after enactment and by registered importers one year after\nenactment.",
      "type": "CRS Report",
      "typeId": "REPORTS",
      "active": false,
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      "topics": []
    }
  ],
  "topics": [
    "Appropriations"
  ]
}