Letter to FDA Commissioner Mark McClellan re: RU-486     9/26/2003

The complication that killed Holly Patterson was entirely predictable.

September 26, 2003

Mark McClellan, M.D.
Commissioner
U.S Food and Drug Administration
5600 Fishers Lane
Rockville MD 20857

Dear Commissioner McClellan:

The death last week of Holly Patterson from complications of an incomplete mifepristone-induced abortion should prompt the Food and Drug Administration to suspend distribution of this dangerous drug and reconsider its approval.

The complication that killed Holly Patterson was entirely predictable. In the clinical trials that served as the basis for approval of this drug, the rate of incomplete abortions was estimated at 5 to 8 percent. This is a potentially lethal complication, as the death of Holly Patterson demonstrates, and it is appalling that a drug associated with such a high rate of serious complications was ever approved at all.

That approval was, however, completed under a legal provision that gives the FDA post-approval monitoring authority to ensure that the drug is administered according to the prescribed protocol. According to the FDA's instructions, mifepristone is not to be administered to any patient whose pregnancy has advanced more than 49 days LMP, and both the mifepristone and the subsequent dose of misoprostol are to be administered under a physician's supervision.

Planned Parenthood Golden Gate advertises on its website that it offers mifepristone to patients who are up to 63 days pregnant, and (as in the case of Holly Patterson) that patients are to self-administer the misoprostol. Both of these practices violate the FDA-prescribed regimen for the use of this drug. Obviously, Danco, the company that sells this drug, is not fulfilling its responsibility to ensure that the drug is used as required. And just as obviously, the FDA is not using its post-approval monitoring authority to protect patients from improper applications of this drug.

At least two American women have died after being given mifepristone. Many others have suffered serious, even life-threatening complications. This drug is not safe. That was clear from the clinical trials, and it has been confirmed by three years of use. We therefore call on you to halt the distribution and prescription of mifepristone and to reconsider the ill-advised approval of this drug.

Sincerely,

AMERICAN ASSOCIATION OF CHRISTIAN SCHOOLS
Dr. Keith Wieve
President

AMERICAN FAMILY ASSOCIATION
Don E. Wildmon
President

AMERICAN LIFE LEAGUE
Judie Brown
President

AMERICAN VALUES
Gary L. Bauer
President

CAPITOL HILL PRAYER ALERT
Harry S. Valentine
Publisher

CARENET
Kurt Entsminger
President

CATHOLICVOTE.ORG
Larry Cirignano

CHRISTIAN COALITION
Roberta Combs
President

CHRISTIAN LEGAL SOCIETY
James A. Davids
Legal Counsel

COALITIONS FOR AMERICA
Paul M. Weyrich
National Chairman

CONCERNED WOMEN FOR AMERICA
Sandy Rios
President

CULTURE OF LIFE FOUNDATION
Austin Ruse
President

EAGLE FORUM
Lori Waters
Executive Director

FAITH 2 ACTION
Janet Folger
President

FAMILY RESEARCH COUNCIL
Tony Perkins
President

FOCUS ON THE FAMILY
Tom Minery
Vice President of Public Policy

LIFE ADVOCACY RESOURCE PROJECT
Penny Pullen
President

MADISON PROJECT
Michael Bowman
President

NATIONAL CENTER FOR PUBLIC POLICY RESEARCH
Amy Ridenour
President

NATIONAL INSTITUTE OF FAMILY AND LIFE ADVOCATES
Tom Glessner
President

NATIONAL ORGANIZATION OF EPISCOPALIANS FOR LIFE
Georgette Forney
Executive Director

POPULATION RESEARCH INSTITUTE
Steve Mosher
President

PRISON FELLOWSHIP
Charles W. Colsen
Founder & President

RELIGIOUS FREEDOM COALITION
William J. Murray
President

SOUTHERN BAPTIST ETHICS and RELIGIOUS LIBERTY COMMISSION
Barrett Duke
Vice President

SUSAN B. ANTHONY LIST
Christina Muller
Deputy Director of Legislation and Outreach

TRADITION, FAMILY, PROPERTY, INC
C. Preston Noell III
President

TRADITIONAL VALUES COALITION
Andrea Sheldon Lafferty
Executive Director

URBAN FAMILY COUNCIL/PHILADELPHIA-NYC
William Devlin
Founder

VISION AMERICA
Rick Scarborough
President

WILBERFORCE FORUM
Mariam Bell
National Director, Public Policy

Cc: Peter Pitts
FDA Communications Director

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