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Institute of Medicine (US) Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs. Ethical Issues in Studying the Safety of Approved Drugs: A Letter Report. Washington (DC): National Academies Press (US); 2010.

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Ethical Issues in Studying the Safety of Approved Drugs: A Letter Report.

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CONTEXT OF THE INSTITUTE OF MEDICINE STUDY AND CHARGE TO THE COMMITTEE

Public Law 110-85, the Food and Drug Administration Amendments Act of 2007 (FDAAA 2007; PL 110-85) expanded the US Food and Drug Administration (FDA) authorities and responsibilities over drugs1 during the postmarketing period (that is, after a drug is approved to enter the US market). The expanded authorities, many of which were recommended in The Future of Drug Safety: Promoting and Protecting the Health of the Public (IOM, 2007), provide FDA with additional regulatory tools, such as requiring clinical trials or other studies after a drug has been approved, to protect the health of the public. With the expanded postmarketing authorities comes the recognition that critical decisions regarding the study of drugs after approval raise new challenges and questions, both ethical and scientific, for the agency to consider. FDA therefore asked the Institute of Medicine (IOM) to “convene a committee to evaluate the scientific and ethical issues involved in conducting studies of the safety of approved drugs.” The specific questions that the committee was asked to evaluate are presented in Box 1. In light of the scheduling of a joint meeting of FDA’s Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee on July 13–14, 2010, FDA requested a letter report addressing question 1 of the charge—“What are the ethical and informed consent issues that must be considered when designing randomized clinical trials to evaluate potential safety risks?”—by July 2010.

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BOX 1

Charge to the Committee. The Food and Drug Administration (FDA) has requested that the Institute of Medicine convene a committee to evaluate the scientific and ethical issues involved in conducting studies of the safety of approved drugs. Questions to (more...)

Footnotes

1

For simplicity, the committee uses the term drugs throughout this report, but similar considerations would apply to biologics.

Copyright 2010 by the National Academy of Sciences. All rights reserved.
Bookshelf ID: NBK209933

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