Report
Note: Workshop Summaries contain the opinion of the presenters, but do NOT reflect the conclusions of the IOM. Learn more about the differences between Workshop Summaries and Consensus Reports.
The U.S. Food and Drug Administration (FDA) carries out one of the most critical consumer protection functions of the federal government: ensuring the safety of prescription drugs taken by millions of Americans. Since 1992, however, federal funding for the agency has diminished, and recent highly publicized events such as the recall of Vioxx have damaged public confidence in the agency. The IOM report released in September 2006, The Future of Drug Safety: Promoting and Protecting the Health of the Public, provided an independent assessment of the current U.S. drug safety system and included 25 recommendations for improving the system for drug safety review.
Like many government agencies, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments. 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.
Other Reports by this Activity
Displaying: 3 of 7 Reports
-
Addressing the Threat of Drug-Resistant Tuberculosis: A Realistic Assessment of the Challenge. Workshop Summary
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.
Released: August 26, 2009
-
Accelerating the Development of Biomarkers for Drug Safety. Workshop Summary
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.
Released: June 19, 2009
-
Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies. Workshop Summary
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.
Released: February 19, 2009
Previous Meeting for this Activity