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Date: July 9, 2010
Contacts: Christine Stencel, Senior Media Relations Officer
Christopher White, Media Relations Assistant
Office of News and Public Information
202-334-2138; e-mail <email@example.com>
REPORT OFFERS FDA A FRAMEWORK FOR EVALUATING ETHICAL ISSUES
WHEN DECIDING WHETHER TO REQUIRE POSTMARKETING STUDIES OF DRUGS
The report's proposed framework underscores the importance of FDA's decision-making processes and study design considerations. FDA should ensure that any randomized, controlled trial to evaluate the efficacy and safety of an approved drug that is suspected of causing serious adverse events is conducted only when the existing evidence and any evidence from new observational studies would be insufficient to enable the agency to make responsible policy decisions. The agency should determine that questions about a drug's possible risks or risk-benefit balance rise to the level of requiring a policy decision, such as whether to revise the product's label.
In addition, FDA should make sure that trials are appropriately designed to resolve uncertainties about efficacy and safety and to minimize risks to participants. Risks should be judged acceptable by appropriate oversight bodies, and participants and studies should be continuously monitored to assure that the risks continue to be acceptable. The process of informed consent should continue over the course of the trials, and participants should be promptly advised of substantial changes in clinical practice or professional standards and new research findings that could affect their willingness to accept the risks associated with a trial. FDA should apply principles and practices of regulatory science to ensure that its policy decisions reflect the best available scientific evidence and analytic techniques and that they are made in a transparent way to ensure public accountability.
The report responds to one of several questions FDA asked IOM to explore in a review of ethical and scientific issues related to studying the safety of drugs on the market. Specifically, this letter report addresses the ethical and informed consent issues that must be considered when designing randomized clinical trials to evaluate potential safety risks. FDA requested an initial report on the ethical issues in advance of a meeting it will hold July 13 and 14 to discuss the case of the diabetes drug Avandia. The report addresses issues at play in this case, but does not delve into or respond to the specifics of the Avandia case. Rather, the authoring committee provided a conceptual framework that would be broadly applicable to many situations.
Given the short time frame available to prepare the letter report, the study committee did not detail all the ways the issues raised in the report can affect the ethics of a study, or explore issues related to the ethical and scientific justifications of clinical trials in depth. A more detailed analysis of these issues and their implications and effects will be included in the committee's final report, which will be completed in the spring of 2011.
The report was requested by the U.S. Food and Drug Administration. Established in 1970 under the charter of the National Academy of Sciences, the
Copies of Ethical Issues in Studying the Safety of Approved Drugs: A Letter Report are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).
[ This news release and report are available at http://national-academies.org ]
Board on Population Health and Public Health Practice
Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Ruth R. Faden, Ph.D., M.P.H. (co-chair)
Philip Franklin Wagley Professor of Biomedical Ethics, and
Berman Institute of Bioethics
Steven N. Goodman, M.D., M.H.S., Ph.D. (co-chair)
Professor of Oncology, Pediatrics, Epidemiology, and Biostatistics
Alasdair Breckenridge, M.D., F.R.C.P.
Medicines and Healthcare products Regulatory Agency
Lisa Egbuonu-Davis, M.D., M.P.H., M.B.A.
Miguel A. Hernán, M.D., Dr.P.H.
Department of Epidemiology
Grace M. Lee, M.D., M.P.H.
Department of Population Medicine
Assistant Professor of Pediatrics
Division of Infectious Diseases, and
Associate Medical Director of Infection Control
Michelle Mello, J.D., Ph.D.
Professor of Law and Public Health
Department of Health Policy and Management
Eric M. Meslin, Ph.D.
Center for Bioethics, and
Associate Dean for Bioethics
Larry I. Palmer, LL.B.
Professor of Health Administration
School of Allied Health Professions
Professor of Law
Marshall-Wythe School of Law, and
Thomas Jefferson Program in Public Policy’s
Bruce M. Psaty, M.D., Ph.D., M.P.H.
Professor of Medicine, Epidemiology, and Health Services, and
Cardiovascular Health Research Unit
Group Health Research Institute
Group Health Cooperative
Thomas R. Ten Have, Ph.D, M.P.H.
Professor of Biostatistics,
Associate Director Biostatistics Unit, and
Center for Clinical Epidemiology and Biostatistics
William Vaughan B.A.
Michelle C. Catlin, Ph.D.