fetaldex.org

letter to the CARES Foundation

 

September 10, 2010


Division of Drug Marketing, Advertising, and Communications

Food and Drug Administration

10903 New Hampshire Ave., Building 51, Room 3200

Silver Spring, MD 20993-0002

Phone: 301-796-1200


RE: Complaint (also sent via email to badad@fda.gov)


Dear DDMAC Staff:


We write to you with a complaint regarding the DTC advertisement posted here: http://www.newchf.org/testing.php


A copy is attached. As you can see, the penultimate paragraph makes the following claim about the off-label prenatal use of dexamethasone, a Class C Pregnancy steroid, used in the first trimester for the purpose of preventing ambiguous genitalia in females with congenital adrenal hyperplasia (CAH):


"[...]the treatment has been found safe for mother and child."


In fact, this off-label use continues to be viewed by medical experts as experimental and as one that should only be pursued in IRB-approved clinical trials, as indicated in the attached consensus statement. Moreover, Dr. New's own publication at the NIH-sponsored journal GeneReviews was recently changed to state: "Prenatal treatment should continue to be considered experimental and should only be used within the context of a formal IRB-approved clinical trial." (see the copy attached or see http://www.ncbi.nlm.nih.gov/bookshelf/br.fcgi?book=gene&part=cah) Additionally, Dr. New's presentations to professional conferences and ongoing publications indicates that she is still researching the long-term outcomes of this off-label use in an attempt to establish whether it is safe.


We ask you to protect the rights of pregnant women and their future offspring by requiring Dr. New to tell prospective patients in her DTC ads the same thing she is telling her colleagues: that this off-label drug use "should continue to be considered experimental and should only be used within the context of a formal IRB-approved clinical trial."


Thank you for your kind attention to this matter.


Sincerely


Alice Dreger, Ph.D.

Professor of Clinical Medical Humanities and Bioethics

Feinberg School of Medicine

Northwestern University

750 N. Lake Shore Dr., Suite 625

Chicago, IL 60611


Ellen K. Feder, Ph.D.

Associate Professor of Religion and Philosophy

American University

4400 Massachusetts Ave., NW

Washington, DC 20018-8056