OWH eUpdate 

www.fda.gov/womens Spring 2008 

In This Issue Message from the Director • OWH Research 

• Outreach Initiatives In this Spring update, OWH will share some exciting announcements 

about several new research and outreach projects. Our increased 

funding has allowed us to support more projects than ever before. 

Thus far in FY2008, we have funded over 20 research projects by 

investigators/scientists in the FDA Centers who will be conducting 

regulatory research pertinent to women’s health. We are also able to 

fund a comprehensive outreach collaboration with HRSA. These new 

scientific and educational projects along with our ongoing efforts will 

advance our knowledge of sex differences and promote healthy 

lifestyle behaviors among women. We look forward to sharing the 

results of these projects with you. 

• Hot Topics 

• Reports from the Field 

• Update Extras 

OWH Highlights 

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Science Program 

 Birth Control Kathleen Uhl, MD 

e-Update Archive Assistant Commissioner for Women’s Health 

 FDA Highlights 

OWH Research Heparin 

Latest on Heparin 

investigation 

Intramural Research Grants Announced Report a Problem 

Report problems with 

medical products, 

cosmetics, food, etc. The OWH Intramural Research Program awarded approximately $1.5 

million in grants to fund projects on breast cancer, lupus, 

cardiovascular disease, and hormone therapy. Theses studies will 

utilize innovative and translational science tools such as genetics, 

imaging, and pharmacometrics to advance our understanding of 

these vital women's health issues. In addition, OWH helped support 

the participation of FDA investigators in a large Interagency 

collaboration studying the complications of Lasik eye surgery. 

FDA Newsroom 

Public notices, safety alerts, 

media contacts and more 

Cantaloupe Recall 

Updates on limited recall 

Contact Us 

Each year, OWH supports intra-Agency research that addresses sex 

differences in disease prevalence and response to therapy; health 

issues unique to women, and women's participation in clinical trials. 

These research collaborations with FDA scientists are key to 

fostering the Agency’s ability to examine sex differences. 

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owh@fda.gov
Outreach Initiatives 

OWH Partners with Laura Bush Institute 

OWH is collaborating with the Laura W. Bush Institute for Women’s 

Health at the Texas Tech University Health Sciences Center 

(TTUHSC) to provide health education information to women and 

their families. OWH publications will be used as teaching tools at 

each of TTUHSC’s five schools – Medicine, Nursing, Allied Health 

Sciences, Pharmacy and Graduate School of Biomedical Sciences. In 

addition, OWH materials will be disseminated at hospitals and clinics 

throughout West Texas. 

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OWH and HRSA Create Pharmacy Education Initiative 

OWH and the HRSA Office of Pharmacy Affairs have joined forces to 

develop and implement a Medication Safety and Effectiveness Health 

Education Outreach Project. This new initiative will target 

underserved communities and individuals with special health care 

needs including those diagnosed with HIV/AIDS. OWH will provide 

free consumer information that will be disseminated along with an 

educational tool kit to HRSA grantees. OWH and HRSA will also 

collaborate on a web-based course and information portal for 

pharmacists and other health professionals working at more than 

6,000 urban and rural clinics across the country. 

 

Hot Topics 

Manufacturer Limits Availability of Zelnorm 

Novartis has voluntarily decided to supply Zelnorm (tegaserod 

maleate) for emergency use only. Zelnorm will no longer be 

available under a treatment IND (investigational new drug) protocol. 

Use of Zelnorm was previously restricted at the request of FDA in 

2007 following a safety analysis that found a higher chance of heart 

attack, stroke, and unstable angina (heart/chest pain) in patients 

treated with Zelnorm compared with those treated with an inactive 

substance (placebo). 

For more information on who may qualify for treatment with 
Zelnorm for emergency use, visit the FDA Zelnorm information page 

at: http://www.fda.gov/cder/drug/infopage/zelnorm/default.htm

 

Physicians may contact FDA’s Division for Drug Information about 

the emergency IND process at druginfo@fda.hhs.gov. 

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New FDA Homepage 

In March, FDA unveiled its new home page. The newly designed 

page features an improved layout and user-friendly sections like 

“FDA For You” that provide links to information for consumers, 

health professionals, and industry. The new home page represents 

the first step in the complete re-design of the FDA web site. The 

Agency is working to update the entire site by the end of the year. 

View the new homepage at: www.fda.gov

Comment on the new homepage at: FDA Home Page Comments

Reports from the Field 

OWH provides support for FDA field staff to conduct educational and 

outreach efforts. FDA Public Affairs Specialists exhibit at 

conferences, hold community health events, and foster partnerships 

with local organizations that serve women and their families. 

Highlights of these regional activities are listed below. 

Atlanta District Office 

PAS JoAnn Pittman partnered with the South Atlantic Medical 

Association to print and distribute OWH publications at their 

expense. SAMA will print over 40 fact sheets and medicine booklets 

for their 60,000 physician members across the South. 

Los Angeles District Office 

PAS Laurel Eu is teaming with the Little Tokyo Service Center to 

distribute OWH health materials in Asian and Pacific Islander 

communities throughout Los Angeles. 

New Orleans District Office 

PAS Natalie Guidry showcased Take Time To Care consumer health 

information at the Alabama Food Service & Nutrition Expo in 

Birmingham, AL in March. For the second consecutive year, the OWH 

exhibit was awarded first place in the General Products Category. 
Update Extras 

Upcoming Meetings 

Ophthalmic Devices Panel Of The Medical Devices Advisory Comm. 

Topic: Post Marketing Experience with Lasik 

Date: April 24-25, 2008 

Time: 8:30 a.m. to 5:00 p.m. 

Location: Gaithersburg Holiday Inn, Ballroom, Two Montgomery 

 Village Ave., Gaithersburg, MD 

Website: http://edocket.access.gpo.gov/2008/E8-5810.htm 

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Awards 

Kathleen Uhl, MD, Assistant Commissioner of Women's Health 

received the Henry W. Elliott Distinguished Service Award at the 

2008 American Society for Clinical Pharmacology and Therapeutics 

(ASCPT) meeting in Orlando, Florida. Dr. Uhl was recognized for her 

ongoing service to ASCPT including her current efforts as Associate 

Editor for the Society's journal, Clinical Pharmacology and 

Therapeutics. 

Marsha Henderson, OWH Deputy Director, was honored with the 

Jacob W. Miller Award from the American Pharmacists Association 

(APhA) Foundation. The award was presented in recognition of her 

leadership in improving the quality of consumer health efforts. 

Join us in congratulating Kathleen and Marsha on their distinguished 

honors. 

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Conferences 

Visit the OWH exhibit booth at these upcoming conferences: 

National Black Women’s Health Conference, May 1-3 – Atlanta, GA 

American Psychiatric Association, May 4-7 – Washington, DC 

CDC Diabetes Translation Conference, May 5-8 – Orlando, FL 

National Farmworker Health Conference, May 6-8 – San Juan, PR 

American College Health Association, June 4-6 – Orlando, FL 
Organization for the Study of Sex Differences, June 4-6 – New Orleans 

Mental Health America, June 4-8 – Washington, DC 

American Diabetes Association, June 6-10 – San Francisco, CA 

HIV Prevention Leadership Summit, June 11-14 – Detroit, MI 

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Presentations 

Conference: Organization for the Study of Sex Differences

Poster: Information on QT Prolongation potential in Labels: 

 New Molecular Entity Drugs Approved by FDA, 

 2003-2006 

Authors: Ameeta Parekh, Natalie Gevorkian, Pellavi Sharma, 

 Ellen Pinnow 

Date: June 4-6, 2008 

Location: New Orleans, LA

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