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 Two

THE HISTORY OF THE INTERIM RULE

The history of the Interim Rule involves the discussions that led to its promulgation ; the immediate, but limited, controversy surrounding it; and the FDA decision seven years after the Gulf War to complete the rule-making process. The brief text of the Interim Rule was provided at the end of Chapter One. Its main provisions are these: A process is established by which a determination may be made by the Commissioner of Food and Drugs, pursuant to a written request by the Assistant Secretary of Defense (Health Affairs) (ASD[HA]), that obtaining informed consent for the use of investigational drugs is "not feasible" for a "specific military operation involving combat or the immediate threat of combat." The request must indicate that a duly constituted IRB has reviewed and approved the use of the IND without informed consent. The commissioner, in reaching his or her decision, may find that obtaining informed consent is not feasible "only when withholding treatment would be contrary to the best interests of the military personnel" and when "no available satisfactory alternative therapy" is available.


THE MEMORANDUM OF UNDERSTANDING BETWEEN DOD AND
FDA

A Memorandum of Understanding (MOU) has existed between DoD and FDA for some time that pertains to the "investigational use of drugs, antibiotics, biologics, and medical devices" by DoD (52 FR 33472, September 3, 1987). 1 It provides that clinical testing of investigational drugs, biologics, or medical devices under programs sponsored by DoD, whether conducted within DoD facilities or by a contractor or grantee, will follow FDA regulations governing

____________________
1
Initially executed by the Department of Health, Education, and Welfare and DoD in 1964, the MOU was revised in 1974 to indicate the procedures that would be followed "to ensure that the requirements of the Federal Food, Drug, and Cosmetic Act and its implementing regulations are fully met without jeopardizing or impeding the requirements of national security." It was revised again in 1987, and it is this version that is currently in force.

-13-

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 ...
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.
Sign up now to cite pages or passages in MLA, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

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 page

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

Settings

Typeface
Text size Smaller Larger
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?

Full screen
/ 102

matching results for page

Cited passage

Style
Citations are available only to our active members.
Sign up now 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

Welcome to the new Questia Reader

The Questia Reader has been updated to provide you with an even better online reading experience.  It is now 100% Responsive, which means you can read our books and articles on any sized device you wish.  All of your favorite tools like notes, highlights, and citations are still here, but the way you select text has been updated to be easier to use, especially on touchscreen devices.  Here's how:

1. Click or tap the first word you want to select.
2. Click or tap the last word you want to select.

OK, got it!

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.

For full access in an ad-free environment, sign up now for a FREE, 1-day trial.

Already a member? Log in now.