Message from the Director
Throughout the summer, OWH will conduct scientific and outreach initiatives to continue to shine a light on the importance of women’s health. In this eUpdate, you will find information on some of our recent efforts including a pregnancy research symposium, an outreach promotion with Dear Abby, and training courses for health professionals.
In addition to these projects, OWH has updated our online resources to provide you with timely women’s health information from the FDA. The consumer web portal, FDA For Women, includes a slideshow that will highlight new content and special initiatives, as well as, expanded women’s health topics pages that include more links to FDA and HHS resources. The Women’s Health Research site for health professionals includes links to publications and presentations, scientific workshops, and lists of OWH-Funded research. I encourage you to visit the pages highlighted below as well as the other links featured in this eUpdate.
Marsha Henderson, MRCP
Assistant Commissioner for Women’s Health (Acting)
OWH Research
Symposium on OWH-funded Pregnancy Research
On May 17th, the FDA Office of Women’s Health sponsored a symposium to discuss OWH-funded clinical studies in pregnancy. Held at the FDA White Oak Campus, the symposium brought together more than 100 representatives from government, industry, academia, and the public health community to hear presentations by OWH-funded researchers and to participate in discussions about the challenges in recruiting pregnant women in clinical studies. The Meeting Webcast and Speaker Presentations are available online.
***************************
New Online Course on Sex and Gender Differences
OWH collaborated with the NIH Office of Research on Women’s Health to develop a new, web-based course entitled “Sex and Gender Differences in Health and Behavior”. The new course is the second in a series on “The Science of Sex and Gender in Human Health”.
The course focuses on specific conditions and organ systems including endocrine effects on immunity, drug therapeutics during pregnancy, irritable bowel syndrome, autoimmune disease, and mental health. Participants will learn about sex and gender differences in the course of disease and consider issues that arise when treating and managing these conditions. A research methodology framework to incorporate sex and gender differences in the design of studies is also included.
The course includes 6 lessons and takes approximately 6 hours to complete. CME credits are available from The Johns Hopkins University School of Medicine.
To Learn More: Sex and Gender Differences in Health and Behavior
Other OWH Courses:
-
The Basic Science and the Biological Basis for Sex- and Gender-Related Differences (in partnership with NIH Office of Research on Women’s Health)
-
“Does My Patient Understand?” (in partnership with HRSA Patient Safety Clinical Pharmacy Services Collaborative)
OWH Outreach
Dear Abby features “Healthy Moms Advice Kit”
OWH collaborated with the Federal Citizen Information Center to make a "Healthy Moms Advice Kit" available to Dear Abby readers during National Women’s Health Week. The kit included practical tips on topics such as allergies, depression, food safety, medicine and pregnancy, generic drugs—and every mom's dream—learning the secrets of getting a good night's sleep. In the first week over 50,000 kits were ordered.
Limited quantities of the “Healthy Moms Advice Kit” are still available.
The kits can be ordered online at Publications.USA.gov.
***************************
OWH Sponsors training webcast for HRSA Patient Safety Collaborative
On May 24, 2011, OWH co-sponsored a web-based training course for health professionals participating in the HRSA Patient Safety and Clinical Pharmacy Services Collaborative (PSPC). The four-hour webcast included presentations on successful strategies for clinical pharmacy services and the practical aspects of using data to manage health outcomes and patient safety. The training also included a breakout session on utilizing OWH educational materials to support patient-centered care and disease self-management.
PSPC is a breakthrough effort to improve the quality of health care across America by integrating evidence-based clinical pharmacy services into the care and management of high-risk, high-cost, complex patients. PSPC works through over 120 teams representing community-based health care providers, including health centers, Ryan White HIV/AIDS providers, poison control centers and rural health clinics.
To Learn More:
FDA Meetings
Hearing on Proposal to Withdraw Approval for the Breast Cancer Indication for Bevacizumab (Avastin)
FDA is granting a hearing to Genentech, Inc., on the Center for Drug Evaluation and Research's proposal to withdraw accelerated approval of the breast cancer indication for bevacizumab (Avastin).
Dates: June 28-29, 2011
Time: 8:00 a.m. – 5:00 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave. Bldg. 31, Great Room, Silver Spring, MD 20993
If you wish to attend the hearing or view the hearing via webcast, you must register with FDA in advance of the hearing. The public meeting is free. Seating is limited to 300 persons from the general public. Availability via webcast will be limited to a certain number of persons. FDA asks that you do not register for both attending the hearing in person and viewing the webcast.
To Learn More: Hearing Information
FDA Highlights
Breast Thermography Not a Substitute for Mammography
On June 2, 2011, FDA warned women not to substitute breast thermography for mammography to screen for breast cancer. The FDA is unaware of any valid scientific evidence showing that thermography, when used alone, is effective in screening for breast cancer. To date, the FDA has not approved a thermography device (also referred to as a telethermographic device) for use as a stand-alone to screen or diagnose breast cancer. The FDA has cleared thermography devices for use only as an additional diagnostic tool for breast cancer screening and diagnosis.
Unlike mammography, in which an X-ray of the breast is taken, thermography produces an infrared image that shows the patterns of heat and blood flow on or near the surface of the body.
To Learn More:
***************************
Safety Review of Oral Contraceptives containing Drospirenone
On May 31, 2011, FDA informed the public about new information that is being assessed as part of FDA's ongoing safety review of birth control pills containing the progestin hormone drospirenone. Two recently published studies report that there is an increased risk of deep vein thrombosis (DVT) and pulmonary embolus associated with the use of birth control pills containing drospirenone compared to the risk associated with the use of birth control pills containing a different progestin hormone (levonorgestrel).
FDA is currently evaluating all available information to assess fully the VTE risks of drospirenone-containing birth control pills. FDA will continue to communicate any new safety information to the public as it becomes available.
To Learn More:
***************************
Don’t buy drugs marketed as antimicrobial dietary supplements
On May 13, 2011, FDA warned consumers not to use products marketed as dietary supplements that also claim to be antimicrobial (antibiotic, antifungal or antiviral) drugs. These illegal products are falsely promoted with claims to treat illnesses such as upper respiratory infections, sinusitis, pneumonia, bronchitis and the common cold. These products may or may not contain antimicrobials, and their use could delay treatment for serious illnesses.
The FDA has determined that many of these products mimic the labeling of drugs available in Mexico, and that they are marketed specifically to the Hispanic community. Consumers should stop using these products immediately and contact their health care providers.
To Learn More:
***************************
FDA Initiative to Enhance Diversity on Advisory Committees
The FDA’s Office of Minority Health (OMH) and Office of Special Medical Programs, Advisory Committee Oversight and Management are collaborating on an initiative entitled Enhancing Diversity on FDA Advisory Committees. The Initiative’s goal is to broaden the search for qualified advisory committee candidates with experience with underserved communities.
OMH is supporting the Enhancing Diversity initiative by recruiting potential candidates who have scientific expertise and experience in working with vulnerable populations. A wide range of health professionals are needed, from social scientists and epidemiologists to nurses and physicians.
To Learn More:
Partner Highlights
New NCL Campaign on Medication Adherence
The National Consumers League has launched “Script Your Future” - a national campaign to raise awareness about medication adherence. In partnership with OWH and nearly 100 public and private stakeholder organizations, the campaign will offer adherence resources to help patients and the health care professionals who care for them. The campaign will also include outreach to six cities.
Visit ScriptYourFuture.org to learn more about the campaign.
***************************
New ADA Guide on Depression and Diabetes
The American Diabetes Association Women and Diabetes Workgroup released “Coping with Diabetes” - a new handbook for women. The handbook provides practical tips to help women and their families deal with the emotional challenges of living with diabetes.
Call 1-800-DIABETES to get a copy of the handbook.
Visit www.diabetes.org/women to learn more about ADA resources for women.
Update Extras
Conferences
OWH exhibits and presents at conferences across the country to increase awareness of OWH programs and resources and to increase dissemination of the over 50 OWH fact sheets and brochures available for consumers. Check out an OWH exhibit booth or presentation at one of these conferences:
Organization for the Study of Sex Differences, June 3-6, Oklahoma City, OK
Endocrine Society, June 4- 7 – Boston, MA
American Library Association, June 23-28 – New Orleans, LA
American Diabetes Association, June 24-28 – San Diego, CA
National Alliance on Mental Illness, July 6- 9 – Chicago, IL
American Association of Colleges of Pharmacy, July 9-13 – San Antonio, TX
National Black Nurses Association, July 14-16 – Indianapolis, IN
National Association of Hispanic Nurses, July 19-22 – Las Vegas, NV
National Council of LaRaza, July 23-26 – Washington, DC
NAACP, July 23-28 – Los Angeles, CA
HIV & Violence Against Women, August 13 – Atlanta, GA
National HIV Prevention Conference, August 14-17 – Atlanta, GA
National Assoc. of Community Health Centers, August 28-30 – San Diego, CA
Want more information from the FDA Office of Women’s Health?
Follow OWH on Twitter: http://twitter.com/fdawomen
Visit the OWH website: www.fda.gov/womens
View OWH Research: www.fda.gov/womenshealthresearch
Attend an OWH Presentation: OWH Presentations
***********************************
Please share this update with your network, members, constituents, and community.
FDA Office of Women’s Health
10903 New Hampshire Avenue
WO32 - Room 2333
Silver Spring, MD 20993-0002
301-796-9440
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
