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Bioidentical Hormones - U.S. Senate Special Committee on Aging

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Part 11: Nati<strong>on</strong>al media outreach<br />

Campaign materials developed in Part I were publicized-using several different<br />

approaches and elements to involve partners. These included FDA Public Affairs<br />

31<br />

<str<strong>on</strong>g>Special</str<strong>on</strong>g>ists; media outreach in both print and radio; Internet advertising; print advertising;<br />

outreach to community based organizati<strong>on</strong>s; and direct e-mail.<br />

Campaign C<strong>on</strong>clusi<strong>on</strong>s<br />

Based <strong>on</strong> the combined circulati<strong>on</strong> totals for all media activities used, projecti<strong>on</strong>s of<br />

membership in the community organizati<strong>on</strong>s c<strong>on</strong>tacted, and volume of materials ordered,<br />

the campaign can account for nearly 100 milli<strong>on</strong> times that the menopause message was<br />

delivered to peri-menopausal and postmenopausal women. In additi<strong>on</strong>, the materials<br />

developed as part of this C<strong>on</strong>gressi<strong>on</strong>al mandate c<strong>on</strong>tinue to be requested and distributed.<br />

These materials are free and can be accessed via FDA's Office of Women's Health<br />

website (http://wwwfda.gov/womenslmenopauselmht-FS.htiml) and the Federal<br />

Clearinghouse at Pueblo (www.pueblo.gsa.gov), and are available in both English and<br />

Spanish. An extensi<strong>on</strong> of this campaign involves the development of a brochure <strong>on</strong><br />

FDA-approved medicati<strong>on</strong>s for menopausal symptoms - which has become available in<br />

the past m<strong>on</strong>th. This document was created in resp<strong>on</strong>se to requests from women for an<br />

FDA guide that provides basic informati<strong>on</strong> about menopausal horm<strong>on</strong>e therapy and<br />

describes all prescripti<strong>on</strong>.products currently approved by the Agency for this indicati<strong>on</strong>.<br />

The booklet is not intended to be used in place of the labeling, but to help women talk to<br />

their doctor, nurse, or pharmacist about what they should know about risks and side<br />

effects, and general safe use for each of these medicati<strong>on</strong>s.<br />

CONCLUSION<br />

FDA intends to c<strong>on</strong>tinue to address pharmacy compounding, including compounding of<br />

BHRT products, in a manner that respects traditi<strong>on</strong>al pharmacy compounding. FDA will<br />

pursue enforcement acti<strong>on</strong> against compounded drugs, including compounded BHRT

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