{
  "id": "R45414",
  "type": "CRS Report",
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  "number": "R45414",
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      "title": "Expanded Access and Right to Try: Access to Investigational Drugs",
      "retrieved": "2021-04-12T04:03:45.618583",
      "id": "R45414_4_2021-03-16",
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      "date": "2021-03-16",
      "summary": null,
      "source": "CRSReports.Congress.gov",
      "typeId": "R",
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    {
      "source": "EveryCRSReport.com",
      "id": 587984,
      "date": "2018-11-27",
      "retrieved": "2018-12-04T14:11:50.378610",
      "title": "Right to Try: Access to Investigational Drugs",
      "summary": "The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try (RTT) Act of 2017 became federal law on May 30, 2018. Over the preceding five years, 40 states had enacted related legislation. The goal was to allow individuals with imminently life-threatening diseases or conditions to seek access to investigational drugs without the step of procuring permission from the Food and Drug Administration (FDA). Another goal\u2014held by the Goldwater Institute, which led the initiative toward state bills, and some of the legislative proponents\u2014was focused more on the process: to eliminate government\u2019s role in an individual\u2019s choice.\nThe RTT Act (P.L. 115-176) offers eligible individuals and their physicians a pathway other than FDA\u2019s expanded access procedures to acquiring investigational drugs. It defines an eligible patient as one who (1) has been diagnosed with a life-threatening disease or condition, (2) has exhausted approved treatment options and is unable to participate in a clinical trial involving the eligible investigational drug (as certified by a physician who meets specified criteria), and (3) has given written informed consent regarding the drug to the treating physician.\nIt defines an eligible investigational drug as an investigational drug (1) for which a Phase 1 clinical trial has been completed, (2) that FDA has not approved or licensed for sale in the United States for any use, (3) that is the subject of a new drug application pending FDA decision or is the subject of an active investigational new drug application being studied for safety and effectiveness in a clinical trial, and (4) for which the manufacturer has not discontinued active development or production and which the FDA has not placed on clinical hold.\nThe RTT Act also has provisions that limit how the Secretary of Health and Human Services (through the FDA) can use data regarding clinical outcomes of patients who get these drugs through the RTT pathway; require drug sponsors (usually the manufacturers) to report annually to the Secretary on use of the pathway; and require the Secretary to post certain annual summaries. Finally, the RTT Act states that the sponsor or manufacturer has \u201cno liability\u201d for actions under the RTT provisions. The no-liability provision applies also to a prescriber, dispenser, or \u201cother individual entity\u201d unless there is \u201creckless or willful misconduct, gross negligence, or an intentional tort.\u201d\nBefore the RTT Act, observers discussed several obstacles to access to investigational drugs. These included some that were FDA-related: the difficult process to request FDA permission and the role of FDA as gatekeeper. Some related to why a manufacturer might decline to provide an investigational drug: limited available supply, liability, limited staff and facility resources, and concerns about use of outcomes data. The RTT directly eliminates some of these concerns, addresses some others, and leaves others alone.\nFuture Congresses could look at the RTT Act\u2019s effect on FDA, drug manufacturers, and terminally ill patients. Will more patients get investigational drugs? Congress could look at whether the law sufficiently removed obstacles to access. And how will the changes affect FDA? Four former FDA commissioners warned that the bill would \u201ccreate a dangerous precedent that would erode protections for vulnerable patients.\u201d The first clue may come from how the current commissioner interprets FDA\u2019s role in the implementation of the new law.",
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      "topics": [
        {
          "source": "IBCList",
          "id": 4880,
          "name": "FDA Product Regulation & Medical Research"
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  "topics": [
    "Health Policy"
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}