{
  "id": "RL30913",
  "type": "CRS Report",
  "typeId": "REPORTS",
  "number": "RL30913",
  "active": false,
  "source": "EveryCRSReport.com",
  "versions": [
    {
      "source": "EveryCRSReport.com",
      "id": 100348,
      "date": "2001-04-02",
      "retrieved": "2016-05-24T20:25:37.230941",
      "title": "Pharmaceutical Research and Development: A Description and Analysis of the Process",
      "summary": "A central element of the debate about inclusion of prescription drug benefits in Medicare is the\nprice\nof prescription drugs. A key issue in the debate concerns the relationship between those prices and\nthe pharmaceutical research and development (R&D) costs. While this report will not analyze\nthat\nrelationship directly, it does present a description and assessment of the pharmaceutical R&D\n(drug\ndevelopment) process and the factors that affect costs. Such an analysis should be useful in\naddressing questions about the cost of pharmaceutical R&D and the dependence of prescription\ndrug\nprices in the United States on those costs.\n  Pharmaceutical R&D (drug development) consists of several stages. It begins with drug\ndiscovery followed by preclinical drug development where thousands of candidate chemicals may\nbe screened for attractive therapeutic, pharmacological, and toxicity properties. Successful\ncandidates -- usually 5 or fewer from an original pool that may total 10,000 -- are then subjected to\nthree stages of clinical trials testing the drugs' effectiveness and side effects. If a drug emerges from\nthe trials showing a significant therapeutic benefit, it is submitted to the Food and Drug\nAdministration for marketing approval. If approved, post-marketing surveillance ensues looking for\npossible safety concerns that did not emerge in the earlier trials.\n  The entire drug development process typically takes nearly 15 years. The largest share of that\ntime is devoted to the three stages of clinical trials. Although there is no firm figure for the cost of\ndrug development, estimates have run as high as $500 million for the costs associated with a typical\ndrug. While these costs cannot be stated with any real precision, the true cost is still probably high,\nand the major share of those costs is for clinical trials.\n  Recent advances in molecular biology making use of genetic data developed in the human\ngenome project offer the promise of significantly shortening both drug development and clinical trial\ntime, although it may be several years before these goals are routinely realized. Any significant\nshortening of the development time could reduce pharmaceutical R&D costs and, possibly,\nprescription drug prices. Another factor in the cost equation is the contribution of basic biomedical\nresearch funded by the National Institutes of Health. Such research is very important for drug\ndevelopment, and benefits the pharmaceutical industry by reducing its R&D costs. \n  There are several issues about pharmaceutical R&D that Congress may decide to monitor\nclosely. Two, which are within the scope of this report, concern federal biomedical R&D\nfunding\nand clinical trial practices. With respect to the first, a particular concern is the possibility of\nunnecessary overlap in research sponsored by both NIH and the industry as the latter strives to\nincorporate more of the promise of molecular biology into the pharmaceutical R&D process. \nWith\nrespect to clinical trial practice, of specific concern are human subject protection and the potential\nfor conflict of interest on the part of academic researchers taking part in clinical trials.",
      "type": "CRS Report",
      "typeId": "REPORTS",
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}