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09/03/2010

FDA and Office of Human Research Protection Respond to Fetal Dex Complaint

The September issue of The American Journal of Bioethics, presaged by such astonishing articles as “The Lesbian Drug” in Newsweek, stretched the boundaries of the Journal by engaging questions about the relationship between advocacy and scholarship, the meaning of transgressing boundaries in that regard, and the extraordinary implications of the social and medical debate concerning the administration of dexamethasone during pregnancy in females with congenital adrenal hyperplasia. With the release of the September issue of the Journal, both the FDA and OHRP have released letters responding to the complaints that are the subject of the Target Article by Drs. McCullough, Chervenak et al., and rebuttal from Alice Dreger et al.. In these, the agencies respond directly to accusations made on http://fetaldex.org and in letter form to the Agencies and to Weill Cornell Medical College, among others, regarding Dr. Maria New. New’s commentary can also be found in AJOB today, as can the response to commentators, available free, from McCullough et al., all of which is at http://bioethics.net/journal

LETTER FROM THE FOOD AND DRUG ADMINISTRATION
LETTER FROM THE OFFICE OF HUMAN RESEARCH PROTECTIONS

-Glenn McGee

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