{
  "id": "RL32797",
  "type": "CRS Report",
  "typeId": "REPORTS",
  "number": "RL32797",
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      "id": 344696,
      "date": "2007-01-24",
      "retrieved": "2016-04-07T18:28:40.747029",
      "title": "Drug Safety and Effectiveness: Issues and Action Options After FDA Approval",
      "summary": "COX-2 inhibitors and SSRIs\u2014the U.S. public has become more familiar with these technical abbreviations for biochemical processes than one might expect from our general level of science knowledge. Safety concerns about these drugs\u2014used primarily to treat pain and depression\u2014have turned a spotlight on the Food and Drug Administration (FDA) and its approach to protecting the public from drug risks that had not been identified before FDA-approval allowed the drugs on the market.\nTwo regulatory frameworks exist for the review of prescription drugs. First, in the premarket approval process, FDA reviews the safety and effectiveness of new drugs that manufacturers wish to market in the United States. A large part of this review is FDA\u2019s examining the manufacturer-provided data from clinical testing\u2014studies in which humans take the investigational new drug in carefully controlled, and usually randomized, trials\u2014from progressively larger Phase I, II, and III trials.\nSecond, after a manufacturer has sufficiently demonstrated a drug\u2019s safety and effectiveness for a defined population and specified conditions, and the drug is FDA-approved, FDA acts through its postmarket regulatory procedures. Manufacturers must report all serious and unexpected adverse reactions to FDA and clinicians and patients may do so.\nThe law gives FDA authority to take limited action if it finds a drug\u2019s post-approval use presents an increased risk of an adverse event. However, many suggest that not only does FDA need a broader range of enforcement tools, but that FDA also is not taking full advantage of the authority it does have.\nWhile critics of FDA differ in their assessment of what is wrong with FDA\u2019s approach to postmarket safety activities, there is broad agreement that it needs significant change. Discussion of the problems and possible solutions revolves around six areas: FDA organization, FDA budget, role of industry, opportunities to use the drug approval process to enhance postmarket activities, insufficient postmarket information, and lack of public access to available data. Some of the proposed changes lie within the power of FDA to implement. Others would require congressional action.\nThis report examines various options for strengthening FDA\u2019s ability to protect the public. It will be updated from time to time to reflect legislative action by Congress.",
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    {
      "source": "University of North Texas Libraries Government Documents Department",
      "sourceLink": "https://digital.library.unt.edu/ark:/67531/metadc812645/",
      "id": "RL32797_2005Mar08",
      "date": "2005-03-08",
      "retrieved": "2016-03-19T13:57:26",
      "title": "Drug Safety and Effectiveness: Issues and Action Options After FDA Approval",
      "summary": null,
      "type": "CRS Report",
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    }
  ],
  "topics": [
    "Health Policy"
  ]
}