OWH eUpdate 

www.fda.gov/womens Fall 2007 

In This Issue Message from the Director • OWH Research 

Throughout 2007, OWH has worked diligently to promote women's 

health by facilitating high quality science and developing 

partnerships to deliver consumer health messages. In this final 

update for 2007, you will find articles on the outcomes of several 

OWH research and outreach programs including a nationwide 

outreach initiative and new publications. Explore the articles below 

as well as the links to upcoming FDA meetings and information on 

women’s health issues, conferences, and presentations. 

• Outreach Initiatives 

• Hot Topics 

• Update Extras 

OWH Highlights 

Collaboration 2007 

 Free Publications 

Finally, I encourage you to look to OWH in the coming year for new 

research and outreach activities focusing on patient safety and 

health disparities. The OWH research program will continue to 

support projects that aim to increase our understanding of the safety 

and efficacy of FDA regulated products used by women. The OWH 

outreach program will work to increase awareness of health 

conditions negatively impacting women in addition to educating 

women about medication safety. 

Spanish Fact Sheets 

Pregnancy Registries 

e-Update Archive 

FDA Highlights 

Get a Mammogram Find a FDA certified 

mammography facility Kathleen Uhl, MD 

Flu Information Assistant Commissioner for Women’s Health 

Information for health 

professionals and patients 

OWH Research FDA Newsroom 

Public notices, safety alerts, 

media contacts and more 

Journal Article Highlights OWH Research Program Drug Safety Newsletter 

New publication for 

healthcare professionals A recent article in the Journal of Women’s Health chronicles the 

impact of OWH-funded research on FDA policies and regulations 

affecting women. The article provides an overview of the OWH 

research program and discusses several key OWH-funded studies 

that have helped to advance the understanding of sex and gender 

differences. The full citation for the article is listed below. To view 

the PubMed abstract, check ID 17678451

Contact Us 

5600 Fishers Lane 

Room 16-65 

Rockville, MD 20857 

301-827-0350 (phone) 

301-827-0926 (fax) Article: The Food and Drug Administration Office of Women's 

Health: impact of science on regulatory policy. owh@fda.gov

Authors: Obias-Manno D, Scott PE, Kaczmarczyk J, Miller M, Pinnow 

E, Lee-Bishop L, Jones-London M, Chapman K, Kallgren D, Uhl K. 

Journal: Journal of Women’s Health 2007 Jul-Aug; 16(6):807-17 
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OWH supports NIH SCOR Initiative

In September, the NIH Office of Research on Women’s Health 

announced the new Specialized Centers of Research (SCOR) on Sex 

and Gender Factors Affecting Women’s Health. Eleven institutions 

will share a total of $11 million per year for five years. The centers 

will conduct research on vital women’s health concerns such as 

metabolic disorders, osteoporosis, mental health, and pain disorders. 

OWH was proud to collaborate with NIH to support this important 

research initiative. 

To learn more about SCOR, visit: 

http://orwh.od.nih.gov/interdisciplinary/SCORs.html 

To read the press release, visit: 

http://www.nih.gov/news/pr/sep2007/od-24a.htm

Outreach Initiatives 

Nationwide Outreach Initiative with FDA Field Staff 

In January 2007, OWH launched a new nationwide collaboration 

initiative. The aim of the initiative was to work with FDA field staff to 

develop collaborations with local organizations in urban and rural 

communities across the country. These organizations would help 

OWH get critical health information to women and their families 

through a variety of community and church events, adult education 

classes, health programs, and web outreach. 

OWH provided funding to 18 FDA Public Affairs Specialists (PASs) 

who traveled around their regions to meet organizations, distribute 

OWH consumer health materials, and speak/ exhibit at conferences. 

Phase I of the initiative ended in September. To date, the PASs have 

collaborated with over 75 groups, including state and local health 

departments, community groups, universities, hospitals, and local 

businesses. Sample collaborations include: 

Stewart Watson, Florida District Office 

The Three Rivers Regional Library System has placed display racks of OWH 

publications in each of its branches. 

Laurel Eu, Los Angeles District 

The Union of Pan Asian Communities is using OWH publications in their 

health education classes. 

Joan Lytle, New Jersey District 

The New Jersey Department of Health and Senior Services distributed fact 

sheets and medicine booklets at the NJ Caregiver's Conference. 
Ruth Marcano, US Virgin Islands 

The Fredrick Lutheran Church held a Women's Convention that featured 

Take Time To Care materials. 

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OWH and AWHONN hold Nurses’ Stakeholder Meeting

On September 18, OWH partnered with the Association of Women’s 

Health, Obstetric, and Neonatal Nurses (AWHONN) to host an 

information gathering meeting with 20 national nursing 

organizations. The goal of the meeting was to discuss strategies for 

working with nurses and nurse practitioners to disseminate FDA 

health information to women. This meeting was the final in a series 

of three meetings designed to create women's health information 

networks. OWH met earlier this year with leaders from women's 

groups and organizations that serve Spanish-speaking communities. 

Hot Topics 

Online Course on Breast Cancer Detection 

Medscape from WebMD is offering an online CME course called 

“Follow Up of Abnormal Clinical and Imaging Findings of the 

Breast: Five Self-Study Modules for Primary Care Clinicians”. 

The course is designed to educate healthcare providers on the early 

detection of breast cancer. It includes five modules on anatomy, 

health history and clinical breast exams, abnormal clinical findings, 

biopsy methods, and risk management. 

Co-authored by OWH medical officer, Joseph Kaczmarczyk, the 

course was developed by Medscape, CDC, and ACOG in consultation 

with the FDA. The course is open to registered members of 

Medscape. (Registration is FREE.) 

To view the course, visit: 

http://www.medscape.com/editorial/public/breastcancer-cdc

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New Drug Safety Newsletter 

In September, FDA launched a new quarterly newsletter for health 

professionals. The Drug Safety Newsletter aims “to enhance 

communication of new drug safety information, raise awareness of 

reported adverse events, and stimulate additional adverse event 
reporting”. The newsletter is designed to alert providers to 

postmarketing safety signals detected through reviews conducted by 

the FDA Center for Drug Evaluation and Research (CDER). 

To learn more about the Drug Safety Newsletter, go to: 

http://www.fda.gov/cder/dsn/default.htm 

To subscribe to the Drug Safety Newsletter, go to: 

https://list.nih.gov/cgi-bin/wa?SUBED1=fda-dsn&A=1

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Lead Levels in Lipstick 

The FDA is aware of reports regarding lead levels in lipstick. FDA 

analyses to date have not supported the concerns about lead. 

However, the agency is looking into the specific details of recent 

reports and will need to independently confirm this information to 

determine what action, if any, needs to be taken. 

Under the Food Drug and Cosmetic Act, FDA can take regulatory 

action against cosmetics deemed to be “adulterated”. The Act does 

not give the FDA legal authority to require that cosmetics be 

approved before they go on the market. The Act does require premarket approval for color additives – including those used in lipstick. 

To learn more about FDA’s authority over cosmetics, go to: 

http://www.cfsan.fda.gov/~dms/cos-206.html

Update Extras 

Upcoming Meetings 

Mammography Quality Assurance Advisory Committee 

Topic: Interventional Mammography 

Date: November 5, 2007 

Time: 9:00 am – 5:00 pm 

Location: Crown Plaza Rockville – Remington II and III in Ballroom 

 3 Research Ct., Rockville, MD 

Website: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-17795.htm

Public Meeting on Behind-the-Counter Availability of Drugs 

Date: November 14, 2007 

Time: 8:00 a.m. – 5:00 p.m. 

Location: National Transportation Safety Board conference Center 

 429 L’Enfant Plaza SW, Washington, DC 

Website: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-19329.pdf
Pediatric Advisory Committee 

Topic: Draft Guidance on Clinical Lactation Studies 

Date: November 29, 2007 

Time: 8:00 am – 4:00 pm 

Location: Hilton – Grand Ballroom 

 620 Perry Parkway, Gaithersburg, MD 

Website: http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-20304.htm 

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Conferences 

The OWH Outreach Team is busy exhibiting at conferences across 

the country to increase awareness and dissemination of the over 50 

OWH health education fact sheets and brochures available for 

consumers. 

Visit the OWH exhibit booth at these upcoming conferences: 

American Public Health Association, November 3-7 – Washington, DC 

US Conference on AIDS, November 7-9 – Palm Springs, CA 

Association of Nurses in AIDS Care, November 8-11 – Orlando, FL 

CDC HIV Prevention Conference, December 2-5 – Atlanta, GA 

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Presentations 

Conference: American Heart Association 

Presentation: What is new at FDA's Office of Women's Health 

Session: Heart Disease in Women: Where are We Now, Where are 

 We Going? 

Authors: Kathleen Uhl

Date/ Time: November 3, 2007 – 1:30 p.m. 

Location: Orlando, FL 

Conference: American Public Health Association 

Presentation: Enrollment of women and racial minorities in clinical trials 

 for diabetes medications 

Authors: Ellen Pinnow, Pellavi Sharma, Ameeta Parekh, Kimberly 

 Thomas, Lina Aljuburi, Kathleen Uhl

Date/ Time: November 5, 2007 – 10:30 a.m. 

Location: Convention Center, Washington, DC 

Conference: American Public Health Association 

Presentation: Lack of Planned Subgroup Analysis: Review of Drug 

 Protocols Submitted to the FDA 

Authors: Pellavi Sharma, Ellen Pinnow, Pamela Scott, Janelle 

 Derbis, Theresa Toigo, Kathleen Uhl 

Date/ Time: November 5, 2007 1:30 PM 
Location: Convention Center, Washington, DC

Conference: American Public Health Association 

Presentation: Bringing science to consumers: Designing appropriate 

 health education materials 

Authors: Alison Lemon

Date/ Time: November 6, 2007 – 2:30 p.m. 

Location: Convention Center, Washington, DC

Conference: American Public Health Association 

Poster: An update on the OWH pregnancy exposure registry listing 

Authors: Pellavi Sharma, Ameeta Parekh, Elizabeth Duvall-Miller, 

 Connie O'Leary, Kathleen Uhl 

Date/ Time: November 7, 2007 8:30-9:30 AM 

Location: Convention Center, Washington, DC 

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