OWH eUpdate 

www.fda.gov/womens Fall 2008 

In This Issue 

• OWH Research 

• Outreach Initiatives 

• Hot Topics 

• Update Extras 

OWH Highlights 

Join Us 

Research & Development 

Medication Booklets 

Free Publications 

e-Update Archive 

FDA Highlights 

Misbranded Ovasure Test 

FDA issues warning letter 

Mammography Website 

Find a certified 

mammography facility 

Melamine Contamination 

FDA assessment of 

melamine in formula & other 

foods 

FDA Newsroom 

Public notices, safety alerts, 

media contacts and more 

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owh@fda.gov

Message from the Director 

As we begin a new fiscal year in the federal government, the OWH 

staff has already begun to take stock of the initiatives we have 

conducted throughout the previous year and to make plans for the 

future. Throughout the year, OWH has supported research and 

outreach efforts with a focus on safety. In this update we highlight 

an educational project on safe medication use and a new publication 

on the assessment of the sex differences impacting the safety and 

efficacy of FDA-regulated products. I encourage you to read these 

articles as well as the highlights of other Agency initiatives. As 

always, we will continue to provide future updates about our ongoing 

programs and new collaborative projects with our diverse partners. 

 

Kathleen Uhl, MD 

Assistant Commissioner for Women’s Health 

 

OWH Research 

OWH Director Pens Article on Assessing Sex Differences 

OWH Director Kathleen Uhl co-authored a recent article entitled 

“Assessing sex differences: methodological considerations” that was 

published in the September 2008 edition of Expert Reviews in 

Clinical Pharmacology [Vol. 1(5): 585-587]. Uhl and co-author 

Sherry Marts called for the consideration of sex differences in the 

design and implementation of clinical studies. The article highlighted 

the need to address issues related to clinical study recruitment, data 

analysis, measurement methodology, and other study design 

factors. 

The Journal can be found at: www.expert-reviews.com
Outreach Initiatives 

OWH Celebrates “Talk About Prescriptions Month” 

OWH will team up with InnovationRx, a prescription management 

and medication adherence service, and PPSI, Pharmacists Planning 

Service, Inc, to target pharmacists throughout California during 

“Talk About Prescriptions Month”. In October, 5,000 pharmacists will 

receive a medication safety tool-kit that features the OWH My 

Medicines brochure. In addition to the tool kit, InnovationRx will 

reprint an additional 10,000 My Medicines brochures at their 

expense for distribution to participating pharmacists. 

Visit the My Medicines Website at: 

http://www.fda.gov/womens/taketimetocare/mymeds.html 

My Medicines is now available in Arabic at: 

http://www.fda.gov/womens/TakeTimeToCare/Meds_Ara.html

Hot Topics 

FDA Approves Expanded Uses for Gardasil

On September 12, 2008, FDA announced the approval of the vaccine 

Gardasil for the prevention of vaginal and vulvar cancer caused by 

Human Papillomavirus (HPV) types 16 and 18 in girls and women 

ages 9 to 26. These two HPV types cause 70 percent of cervical 

cancers, and are known to also cause some vulvar and vaginal 

cancers, but the percentages are not well defined. 

Gardasil’s label has been revised to note that presently available 

information is insufficient to support use beyond age 26, the current 

FDA-approved age. Also, new information has been added showing 

that Gardasil does not protect against diseases caused by HPV types 

not contained in the vaccine. 

FDA originally approved Gardasil in 2006 for girls and women ages 9 

to 26 for the prevention of cervical cancer caused by HPV types 16 

and 18, precancerous genital lesions caused by HPV types 6, 11, 16, 

and 18 and genital warts caused by HPV types 6 and 11. 

Updated safety information on Gardasil was published on July 22 

and can be found at: 

www.fda.gov/cber/safety/gardasil071408.htm 

The full FDA press release can be viewed at: 

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01885.html 
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FDA to Post Quarterly Report of Potential Safety Issues 

On September 5, 2008, FDA posted on its Web site its first quarterly 

report of drugs that are being evaluated for potential safety issues. 

The drugs have been identified based on reviews of reports in FDA's 

Adverse Event Reporting System (AERS). 

The report lists any potential signals of serious risks and new safety 

information that were identified using the AERS database during the 

indicated quarter. The appearance of a drug on this list does not 

mean that FDA has concluded that the drug has the listed risk or 

that FDA has identified a causal relationship between the drug and 

the listed risk. It is on the list only because FDA has identified a 

potential safety issue. FDA will complete its evaluation of each 

potential safety issue and may issue additional public 

communications as appropriate. 

FDA emphasized that the listing of a drug on this Web site does not 

mean that FDA is suggesting that healthcare providers should not 

prescribe the drug or that patients taking the drug should stop 

taking the medication. Patients who have questions about their use 

of the identified drug should contact their health care provider. 

The quarterly report can be found at: 

http://www.fda.gov/cder/aers/potential_signals/default.htm 

The full FDA press release can be viewed at: 

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01881.html 

*************************** 

New FDA Websites on Drug/ Device Advertisements 

On September 3, FDA launched two new websites to provide 

information for consumers and industry about how FDA regulates 

the promotion of medical products. 

The “Advertising Prescription Drugs and Medical Devices” 

website provides industry and policy users with access to relevant 

laws, regulations, and guidances on medical product promotion. 

This site can be found at: http://www.fda.gov/oc/promotion/ 

 

The “Be Smart about Prescription Drug Advertising: A Guide 

for Consumers” website is designed to educate the general public 

about direct-to-consumer (DTC) advertising. The site includes 
interactive examples of advertisements, as well as, other useful 

tools on DTC ads. This site can be found at: 

http://www.fda.gov/cder/ethicad/index.htm 

Update Extras 

HHS NEWS 

HHS has issued Physical Activity Guidelines for Americans. The 

2008 guidelines outline the types and amounts of physical activity 

that will provide health benefits. Materials are available for 

consumers, health professionals, researchers, and policy makers. 

The guidelines can be accessed at: 

www.health.gov/PAguidelines/ 

 

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Upcoming Meetings 

Peripheral and Central Nervous System Drugs Advisory Committee 

Topic: Radionuclide imaging products for the detection of 

 amyloid to assist in the diagnosis of Alzheimer’s Disease 

Date: October 23, 2008 

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

Location: Hilton Washington DC/Silver Spring, The Ballrooms, 

 8727 Colesville Rd., Silver Spring, MD 

Website: 

http://www.fda.gov/oc/advisory/accalendar/2008/PandCNSMtg102308.

html 

NIH Office of Research on Women’s Health Seminar Series 

Topic: Sex and Gender Research in the Urinary Tract 

Date: October 16, 2008 

Time: 1:00 –3:00 p.m. 

Location: Lipsett Amphitheater, Building 10, NIH Campus 

Contact: Marsha Love at lovem@od.nih.gov or 301-402-1770 

*************************** 

Presentations

Conference: American Public Health Association

Presentation: Educating African American and Hispanic women about 

 early detection of breast cancer through mammography

Speaker: Kimberly Thomas 

Date: October 28, 2008 

Location: San Diego, CA 
Conference: National Caregiver Conference

Presentation: FDA Office of Women's Health: Providing Caregivers 

 with Free, High-Quality Health Care Information 

Speaker: Susana Perry 

Date: October 29, 2008 

Location: Woodbridge Hotel - Iselin, NJ 

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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: 

NRHA Critical Access Hospital Conf., October 15-17 – Savannah, GA 

Nurse Practitioners in Women’s Health, October 15-17 – Seattle, WA 

Employee Assistance Professionals, October 15-18 – Atlanta, GA 

National Conf. on Correctional Healthcare, October 18-22 – Chicago, IL 

New York College Health Association, October 22-24 – Atlanta, GA 

American Public Health Association, October 26-29 – San Diego, CA 

National Caregiver Conference, October 29 – Iselin, NJ 

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We endeavor to provide timely information for your use. 

Feel free to share this with your network, members, 

constituents, and community.