Press Office
Food and Drug Administration
U.S. Department of Health and Human Services


STATEMENT                    Print Media:         301-827-6242
April 6, 1998                
                             Consumer Inquiries:  800-532-4440

STATEMENT FROM FDA LEAD DEPUTY COMMISSIONER MICHAEL A. FRIEDMAN, M.D. ON THE NCI BREAST CANCER PREVENTION TRIAL STUDY

The Food and Drug Administration applauds research efforts conducted on important issues like breast cancer prevention. For the tens of thousands of women who are diagnosed with breast cancer each year, this landmark study is encouraging news.

While initial reports about the potential utility of tamoxifen in preventing breast cancer are certainly positive, like all drugs, there are also some risks. Although tamoxifen has been approved for the treatment of breast cancer patients, FDA must first review the clinical trial data before approving it for the prevention of breast cancer. We are already in contact with the NCI and the study sponsors to obtain the data. Once we receive it, we are committed to a thorough review within six months.

The federal government has been dedicated to investing time and resources into breast cancer research. This study is another example of the importance of continued research in our fight against this life threatening disease.

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