About Reports

IOM reports provide objective and straightforward advice to decision makers and the public. This site includes IOM reports published after 1998. All reports from the IOM and the National Academies, including those published before 1998, are available from the National Academies Press.

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  Addressing the Threat of Drug-Resistant Tuberculosis: A Realistic Assessment of the Challenge. Workshop Summary Released: August 26, 2009

  Tuberculosis is one of the leading causes of death in the world today, with 4,500 people dying from the disease every day. Many cases of TB can be cured by available antibiotics, but some TB is resistant to multiple drugs--a major and growing threat worldwide. The Institute of Medicine’s Forum on Drug Discovery, Development, and Translation hosted a workshop on November 5, 2008, to address the mounting concern of drug-resistant TB. The session brought together a wide range of international experts to discuss what is known and not known about this growing threat, and to explore possible solutions.
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  Accelerating the Development of Biomarkers for Drug Safety. Workshop Summary Released: June 19, 2009

  Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM’s Forum on Drug Discovery, Development, and Translation held “Assessing and Accelerating Development of Biomarkers for Drug Safety,” a one-day workshop on the value of biomarkers in helping to determine drug safety during development.
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  Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies. Workshop Summary Released: February 19, 2009

  The process for developing new drug and biologic products is extraordinarily expensive and time-consuming—many consider the traditional model to be unsustainable. Although large pharmaceutical companies may be able to invest in the development of blockbuster drugs because they can expect a large return on their investment, these same organizations, when developing drugs to treat rare and neglected diseases, are unable to rely on such returns. On June 23, 2008, the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation held a public workshop, “Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies,” which sought to explore new and innovative strategies for developing drugs for rare and neglected diseases.
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  Addressing the Barriers to Pediatric Drug Development. Workshop Summary Released: August 22, 2008

  The majority of drugs prescribed for children—50 to 75 percent—have not been tested in pediatric populations. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.
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  Emerging Safety Science. Workshop Summary Released: April 9, 2008

  In April 2007, the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation convened a workshop entitled “Emerging Safety Science” to examine the use of emerging safety science technologies in drug development and to consider their application in the drug review process. This publication summarizes the presentations and discussions during that workshop.
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  Challenges for the FDA: The Future of Drug Safety. Workshop Summary Released: September 10, 2007

  To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM’s Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. The symposium addressed the financial implications of many of the IOM’s recommendations, including strengthening the scientific base of the agency, integrating pre- and postmarket review, enhancing postmarket safety monitoring, conducting confirmatory drug safety and efficacy studies, improving clinical trial registration, and bolstering FDA’s regulatory and enforcement authority. The proceedings of the symposium are summarized in Challenges for the FDA: The Future of Drug Safety, Workshop Summary.
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  Understanding the Benefits and Risks of Pharmaceuticals. Workshop Summary Released: August 15, 2007

  All pharmaceutical products have inherent risks, and their use involves trade-offs between these risks and their therapeutic benefits. However, the public has a limited understanding of this trade-off, and many individuals believe that drugs approved by the Food and Drug Administration carry no risks. Assessing, managing, and communicating the benefit–risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge.
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  Adverse Drug Event Reporting: The Roles of Consumers and Health Care Professionals. Workshop Summary Released: April 12, 2007

  All drugs undergo extensive safety and efficacy studies before being released; however, these studies can fail to identify potential adverse reactions that are rare or develop over a long period of use. As a result, serious adverse reactions may not be fully appreciated until a drug has been on the market for many years. In November 2005, the Forum on Drug Discovery, Development, and Translation addressed this critical concern by convening a workshop to explore issues associated with the reporting of adverse drug events, and to consider how the roles of clinicians and patients in reporting such events can be enhanced.