OWH eUpdate 

www.fda.gov/womens Winter 2006 

In This Issue Message from the Director • OWH Research 

As another year comes to a close, the FDA Office of Women’s Health 

has begun to take stock of the many initiatives we’ve undertaken in 

2006. The OWH research and development team has strengthened its 

commitment to fund research that will advance the understanding and 

treatment of conditions in women, as well as, advance knowledge of 

sex and gender differences in diagnosis and treatment. The outreach 

program has continued to make great strides in providing national 

organizations, health professionals, community sites, and individual 

women with reliable, easy-to-read health information. Whether it be 

through scientific research or health education, we have reaffirmed 

the true mission of our office, agency, and department which is to, in 

some measure, improve the health of women and their families. 

• Outreach Initiatives 

• Hot Topics 

• Update Extras 

OWH Highlights 

HPV Fact Sheet

Free Health Info

e-Update Archive

FDA Highlights In the new year, look for new OWH projects and opportunities for 

collaboration. We welcome your input and efforts as we prepare for 

the future. Free FDA Email Lists

Sign-Up for FDA 

Listservs on HIV/AIDS, 

Breast Implants, and 

more Kathleen Uhl, MD 

Safety Information Assistant Commissioner for Women’s Health 

Recalls, withdrawals, 

and safety alerts 

OWH Research and Development Upcoming Meetings

FDA Advisory 

Committee Meetings 

OWH & Society for Women’s Health Research hold Workshop FDA Diabetes Info 

Info on diabetes 

medicines, insulin, and 

devices 

On November 13, 2006, the FDA Office of Women's Health and the 

Society for Women's Health Research sponsored a one-day, public 

workshop to address the potential impact of sex and gender 

differences on research related to FDA’s Critical Path Initiative. The 

workshop focused on the areas of biomarker development, 

pharmacogenomics, and bioinformatics. The aim of the workshop was 

to advance the understanding of the impact of sex differences on the 

development of FDA regulated products – drugs, medical devices, and 

vaccines. The ultimate goal is to improve the diagnosis, treatment, 

and prevention of diseases in women. 

Contact Us 

5600 Fishers Lane 

Room 16-65 

Rockville, MD 20857 

301-827-0350 

(phone) 

301-827-0926 (fax)

ocowh@fda.hhs.gov Industry representatives, researchers, HHS staff, and policy leaders 

were invited to hear presentations on the three research areas as well 

as an overview of the FDA Critical Path Initiative. Breakout sessions 

were also held to provide workshop attendees an opportunity to share 
ideas on the direction of future OWH-sponsored research. 

A recurrent theme in the workshop presentations and discussions was 

the need to move beyond the mere inclusion of women in clinical trials 

towards more “meaningful” data analysis by sex and gender that 

prospectively looks for safety and efficacy outcomes. The need for 

increased public/private partnerships to maximize data sharing was 

also emphasized. Collaborative efforts were encouraged between 

government, academia, industry and patient groups to bring about 

biomarker qualification and validation. Workshop attendees also called 

for the development and universal adoption of data standards and for 

modernization in the areas of in-vitro diagnostics, medical imaging, 

and pre-clinical safety markers. 

The Society for Women’s Health Research will compile and publish a 

report detailing all workshop findings. The report will be made 

available in Spring 2007. 

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Update on FDA/ DCRI Cardiac Safety Partnership 

In September, FDA announced its partnership with the Duke Clinical 

Research Institute (DCRI) to form the Cardiac Safety Research 

Consortium. FDA, under the Critical Path Initiative, will partner with 

the consortium to research new methods for identifying the potential 

effects that drugs and devices have on the heart. 

The FDA Office of Women’s Health is continuing to work with the 

consortium on projects that will identify gaps in knowledge of cardiac 

biomarkers. OWH provided seed money for two research projects. 

The first project will review gender differences in the effects of drugs 

on electrocardiograms (ECGs). A second project will evaluate the four 

current methods of measuring ECGs and develop criteria to determine 

the best method to be used in a separate research study. 

More information about DCRI and cardiac safety can be found at: 

http://cardiac-safety.org/ 

For more information on the Critical Path Initiative, visit: 

http://www.fda.gov/oc/initiatives/criticalpath/

The FDA press release on the FDA/ DCRI partnership can be found at: 

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01467.html 

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OWH Outreach 

Over 3 Million OWH Publications Distributed 

Throughout the year, OWH has utilized multiple partnerships and 

venues to distribute more than 3 million OWH publications to women 

across the country. Materials on a range of women’s health issues 

including menopause, heart disease, and medication safety were 

disseminated. OWH women’s health information kits were promoted 

through Parade Magazine and the “Hints from Heloise” syndicated 

column. Special efforts were also made to provide health information 

to rural women, seniors, and other underserved populations. 50,000 

Spanish language kits were distributed and over 18,000 fact sheets 

and brochures were included in the “Savvy Senior Health Kits”. The 

outreach team also partnered with the Federal Citizen Information 

Center (FCIC) to make OWH publications available to National 

Extension Service staff in rural areas and to librarians in areas 

impacted by Hurricane Katrina. In addition, the OWH outreach team 

developed and distributed new fact sheets on HIV, food safety, 

cosmetics, sleep disorders, hypertension and more. 

In 2007, look for new outreach initiatives and publications including: a 

health fraud campaign, outreach events for college-aged women, 

more Spanish language materials, and redesigned fact sheets and 

medication charts. Also, 22 FDA Public Affairs Specialists who have 

been certified as “Take Time To Care” Coordinators will take part in a 

special partnership initiative to encourage lasting ties between the 

FDA and local organizations in communities around the country. 

To download any of the free OWH publications, go to: 

http://www.fda.gov/womens/pubs.html

To order free OWH materials in bulk, go to: 

http://www.pueblo.gsa.gov/

Hot Topics 

Silicone Breast Implants 

The FDA recently approved the marketing of silicone gel-filled breast 

implants made by two companies for breast reconstruction in women 

of all ages and breast augmentation in women ages 22 and older. The 

products are manufactured by Allergan Corp. (formerly Inamed 

Corp.), Irvine, Calif., and Mentor Corp., Santa Barbara, Calif. 

FDA approved the silicone gel-filled breast implants with a number of 

conditions, including requiring each company to track each implant 

and to conduct a large postapproval study following about 40,000 
women for 10 years after receiving breast implants. 

 

Women should consider many factors when deciding whether to get 

silicone gel-filled breast implants including: 

 Breast implants are not lifetime devices and a woman will likely 

need additional surgeries on her breast at least once over her 

lifetime; 

 Many of the changes to a woman’s breast following implantation 

are irreversible; 

 Rupture of a silicone gel-filled breast implant is most often silent, 

which means that usually neither the woman nor her surgeon 

will know that her implants have ruptured; and 

 A woman will need regular screening MRI examinations over her 

lifetime to determine if silent rupture has occurred. The device 

labeling states that a woman should have her first MRI three 

years after her initial implant surgery and then every two years 

thereafter. The labeling also states that if implant rupture is 

noted on an MRI, the implant should be removed and replaced, if 

needed. 

For more information, visit www.fda.gov/cdrh/breastimplants

To view the full press release, visit: 

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01512.html

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FDA Approves Herceptin for Early Stage Breast Cancer 

FDA expanded the approved use of Herceptin, a biological cancer 

drug. The new indication is for Herceptin, in combination with other 

cancer drugs, for the treatment of HER2 positive breast cancer after 

surgery (lumpectomy or mastectomy). 

In 1998, FDA approved Herceptin for the treatment of metastatic 

breast cancer (cancer that has spread to other sites in the body). On 

November 17, 2006, FDA granted approval to expand the use of 

Herceptin to women with cancer only in the breast or lymph nodes 

which have been removed with surgery. Herceptin should only be 

prescribed for women diagnosed with HER2 positive breast cancer. 

For more information, visit: 

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01511.html

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New FDA Nutrition Tools For Consumers 

On November 14, 2006, the Department of Health and Human 

Services (HHS) and the FDA Center for Food Safety and Applied 

Nutrition (CFSAN) announced the availability of two new learning tools 

to help consumers use the Nutrition Facts label to choose nutritious 

foods and achieve healthy weight management. The tools are Make 
Your Calories Count, a Web-based learning program, and a new

Nutrition Facts Label brochure. 

Make Your Calories Count is designed to help consumers understand 

and use the Nutrition Facts label to plan a healthy diet while managing 

calorie intake. The program guide features an animated character 

called "Labelman" who expertly leads the viewer through a series of 

exercises on the food label. The program includes exercises to help 

consumers explore the relationship between serving sizes and 

calories, while they learn how to limit certain nutrients and get 

enough of others. 

To access Make Your Calories Count, go to: 

www.cfsan.fda.gov/labelman

The new Nutrition Facts Label brochure describes how consumers can 

use the Nutrition Facts label as they shop and plan meals. It includes 

information that will help consumers understand the relationship 

between calories and serving size. The brochure can also be used by 

health professionals to teach people how to make healthier food 

choices. 

This brochure is available at: 

http://www.cfsan.fda.gov/~dms/lab-gen.html

To view the full press release on this initiative, go to: 

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01508.html

Update Extras 

Upcoming OWH Presentations 

To learn more about OWH programs and research, join us at the 

following presentations. 

Presenter: Kathleen Uhl 

Topic: "FDA's Office of Women's Health - Mission, Role, & Programs" 

December 6 @ Slone Epidemiology Center - Boston, MA 

Presenter: Kathleen Uhl 

Topic: "Cardiovascular Disease in Women: What FDA is Doing to 

Address the Gaps in Knowledge" 

December 7 @ University of Massachusetts (Medicine Grand Rounds) -

Worcester, MA 

Presenters: Marsha Henderson and Pamela Scott 

Topic: MQSA & Use of Mammography Services 

January 5-7 @ Miami Chapter of Links, Inc 

Guest Speaker: Kathleen Uhl 

January 9 @ Thomas Jefferson University 

Division of Clinical Pharmacology, Department of Medicine 
Guest Speaker: Kathleen Uhl 

Focus: Translating complicated women’s health issues into 

understandable health information 

January 18 @ National Consumers League - Women’s Health Forum 

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