Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense: Lessons from the Gulf War

By Richard A. Rettig | Go to book overview

Chapter Four

THE INTERIM RULE AND ITS ALTERNATIVES

In this chapter, we deal analytically with the issues associated with the Interim Rule, focusing mainly on the "external" policy issues on which DoD requires the concurrence of FDA. However, we also consider those "internal" issues under the control of DoD, such as provision of information to military personnel about investigational drugs, whose implementation reflects on the merit of the general policy. In the first section, we consider the regulatory issues associated with the Interim Rule, as defined by the FDA's Request for Comments of July 31, 1997. Then, in the second section, we address three alternatives to the Interim Rule: revocation, "anticipatory consent," and other arrangements.


ISSUES ASSOCIATED WITH THE INTERIM RULE

Many, but not all, of the regulatory issues associated with the Interim Rule were raised in FDA's July 31, 1997, Request for Comments (62 FR 40966, July 31, 1997). Since the request constitutes the focus of rule making, and thus policy, the following discussion is organized in relation to the questions it asks. The request is organized by Questions A, B, and C: Question A asks eight numbered questions, of which the eighth has parts (a) through (g); Questions B and C ask about standards of approval. Most of these questions are discussed in this section. However, we consider the question about revocation of the rule (A-1) and the two questions about "anticipatory consent (A-4 and A-5) under "Alternatives to the Interim Rule" below. In addition, several questions are addressed in Chapter Five, "Broader Issues." Table 2 provides a guide to how the questions asked by FDA in its Request for Comments are considered in the text.

Question A-2 asks, "Are there circumstances under which the use of the Interim Rule would be justified? If so, what are those circumstances?" Several bioethicists, as noted above, answer this question with an absolutist position: The Nuremberg Code provides no basis for exceptions to informed consent on human subjects of research, and thus the Interim Rule is not justified. An abso

-59-

Notes for this page

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items

Items saved from this book

This book has been saved
Highlights (0)
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

Citations (0)
Some of your citations are legacy items.

Any citation created before July 30, 2012 will labeled as a “Cited page.” New citations will be saved as cited passages, pages or articles.

We also added the ability to view new citations from your projects or the book or article where you created them.

Notes (0)
Bookmarks (0)

You have no saved items from this book

Project items include:
  • Saved book/article
  • Highlights
  • Quotes/citations
  • Notes
  • Bookmarks
Notes
Cite this page

Cited page

Style
Citations are available only to our active members.
Buy instant access to cite pages or passages in MLA, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited page

Bookmark this page
Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense: Lessons from the Gulf War
Table of contents

Table of contents

  • Military Use of Drugs Not Yet Approved by the Fda for Cw/Bw Defense *
  • Preface v
  • Contents vii
  • Figure and Tables ix
  • Summary xi
  • Acknowledgments xvii
  • Glossary xix
  • Chapter One - Introduction 1
  • Chapter Two - The History of the Interim Rule 13
  • Chapter Three - What Uses of Drugs Are Investigational? 41
  • Chapter Four - The Interim Rule and Its Alternatives 59
  • Chapter Five - Broader Issues 81
  • Chapter Six - Conclusions and Recommendations 95
  • Chapter Seven - Postscript 97
  • References 99
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this book

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Help
Full screen
/ 102

matching results for page

    Questia reader help

    How to highlight and cite specific passages

    1. Click or tap the first word you want to select.
    2. Click or tap the last word you want to select, and you’ll see everything in between get selected.
    3. You’ll then get a menu of options like creating a highlight or a citation from that passage of text.

    OK, got it!

    Cited passage

    Style
    Citations are available only to our active members.
    Buy instant access to cite pages or passages in MLA, APA and Chicago citation styles.

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

    1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

    Cited passage

    Thanks for trying Questia!

    Please continue trying out our research tools, but please note, full functionality is available only to our active members.

    Your work will be lost once you leave this Web page.

    Buy instant access to save your work.

    Already a member? Log in now.

    Author Advanced search

    Oops!

    An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.