Message from the Director
This is an exciting time for the FDA Office of Women’s Health. We recently launched a new outreach initiative targeting Latinas and are expanding our efforts to use video and social media to educate women. We are also renewing our efforts to promote the participation of women in clinical trials through public and private partnerships such as our recent conference on Diversifying Clinical Trials. I encourage you to take a look at this update to learn about these activities and more.
Before I let you go, I want to take this opportunity to thank Dr. Vivian Pinn for her leadership and service to women’s health. From her time as the only woman and only African American in her class at the University of Virginia School of Medicine to her service as the first full-time director of the Office of Research on Women’s Health at NIH, Dr. Pinn has been a trailblazer, scholar, and standard bearer for excellence. Her efforts to create a diverse research portfolio have left a legacy that will continue to inspire innovation in women’s health for years to come. Vivian, for your lifetime of service, we thank you.
Marsha Henderson, MRCP
Assistant Commissioner for Women’s Health
OWH Research
OWH and SWHR Sponsor Dialogues on Diversifying Clinical Trials Conference
OWH welcomed the opportunity to collaborate with the Society for Women's Health Research to hold a two-day conference to share a best practices approach to successful and innovative recruitment, retention, and analysis of women and minorities in clinical research. Over 200 representatives from government, industry, patient advocacy, and the scientific community came together to discuss strategies for increasing the participation of women and minority populations in clinical trials.
The conference included roundtable discussions and presentations on research design, cultural and linguistic competency, federal policies and regulations, and community collaborations. The meeting also featured welcoming remarks by FDA Commissioner Margaret Hamburg, DHHS Deputy Assistant Secretary Garth Graham, PhRMA Representative Jose Reynal and SWHR President/CEO Phyllis Greenberger. A white paper capturing new strategies and proposed solutions identified during this meeting will be published in 2012. Due to the enthusiastic participant response, OWH will also look for ways to continue the dialogue in the future.
View Agenda, Webcast, and Speaker Presentations
Visit the OWH Website on Women’s Participation in Clinical Trials
OWH Outreach
OWH launches ¡Nunca Más! Initiative for Latinas
On October 6, 2011, OWH launched ¡Nunca Más! - a new initiative designed to educate Hispanic women and their families about safe medication use. ¡Nunca Más! utilizes a series of Spanish language video novelas (soap operas) to showcase the pitfalls of medication misuse and to highlight medication safety tips. The ¡Nunca Más! initiative provides Hispanic leaders with access to four novelas and free educational materials to help them organize novela viewings and discussion groups for Hispanic women.
A new novela episode will be released every Thursday in October. If you are interested in holding a ¡Nunca Más! viewing party or discussion, view the novelas and toolkit at:
www.fda.gov/ForConsumers/ByAudience/ForWomen/ucm269846.htm
***************************
New Video on Safe Medication Use
OWH is expanding its “Use Medicines Wisely” initiative by debuting a new public service announcement. The video highlights tips for safe medication use and encourages women keep a My Medicines record keeper to track the prescription and over-the-counter medicines they take. The PSA was made available to over 200 stations nationwide and posted to the FDA YouTube Channel for airing during October which is “Talk about Prescriptions Month”.
Please share the video with your stakeholders on your website, Facebook, or Twitter: http://www.youtube.com/user/USFoodandDrugAdmin#p/u/5/54MFiE8odC8
To Learn More: www.fda.gov/womenshealthsafemeds
***************************
Free Mammography Resources Available
OWH invites you to join the Pink Ribbon Sunday program and distribute free mammography resources in your community. OWH launched the Pink Ribbon Sunday program to educate African American and Hispanic women about early detection of breast cancer through mammography. The program strives to reduce breast cancer health disparities by empowering community leaders to develop mammography awareness programs.
Visit the Pink Ribbon Sunday website to download or order a Pink Ribbon How-to-Guide, mammography fact sheets and the new "Find A Mammography Facility" postcard.
To Learn More:
FDA Highlights
Safety Review Update on Birth Control Pills containing drospirenone
On September 26, 2011, FDA informed the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. FDA has completed its review of the two 2011 studies that looked at the risk of blood clots for women who use drospirenone-containing birth control pills, previously mentioned in FDA's Drug Safety Communication issued on May 31, 2011 FDA is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.
FDA has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011 to discuss the risks and benefits and specifically the risk of blood clots of drospirenone-containing birth control pills.
To Learn More: FDA Drug Safety Communication
***************************
Primatene Mist No Longer Available after Dec. 31, 2011
Primatene Mist, the only over-the-counter asthma inhaler sold in the United States, will no longer be available next year as part of a phase-out of epinephrine inhalers containing chlorofluorocarbons (CFCs). No CFC-containing epinephrine inhalers can be made or sold after Dec. 31, 2011, to comply with an international agreement signed by the United States, in which countries agreed to phase-out substances that deplete the ozone layer, including CFCs.
If you rely on an over-the-counter inhaler to relieve your asthma symptoms, it is important that you contact a health care professional to talk about switching to a different medicine to treat your asthma. There are many other safe and effective inhalers to treat asthma symptoms. All of these inhalers require a prescription, which must come from a licensed health care professional.
To Learn More:
- Phase-Out of Epinephrine CFC Metered-Dose Inhalers
- FDA Drug Safety Podcast on Primatene Mist
- Consumer Update
FDA Advisory Committee Meetings
National Mammography Quality Assurance Advisory Committee
Date and Time: November 4, 2011, from 8 a.m. to 6 p.m.
Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave, Gaithersburg, MD
The committee will provide advice and recommendations on the following issues: (1) Proposed changes to the Mammography Quality Standard Act (MQSA) policies and inspection procedures; (2) accreditation body review of soft copy mammography images; and (3) reporting breast density on mammography reports and patient lay summaries. The committee will also receive updates on the MQSA program and the status of the Full Field Digital Mammography universal quality control manual.
***************************
Joint Meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
Date and Time: December 8, 2011, 8:00 a.m. to 5:00 p.m.
Location:
Marriott Inn and Conference Center University of Maryland University College (UMUC)
3501 University Blvd. East, Adelphi, Maryland
The committees will discuss the benefits and risks of drospirenone-containing oral contraceptives in light of the emerging safety concern that the risk of venous thromboembolism (blood clots that can break loose and move within the circulatory system) associated with use of these products may be higher compared to oral contraceptives that contain the progestin, levonorgestrel. Drospirenone-containing oral contraceptives for the primary indication of pregnancy prevention include: YASMIN, YAZ (drospirenone/ethinyl estradiol tablets), BEYAZ, SAFYRAL (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), Bayer HealthCare, and the generic equivalents for these products.
View December 8th Meeting Announcement
***************************
Joint Meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
Date and Time: December 9, 2011, 8:00 a.m. to 5:00 p.m.
Location:
Marriott Inn and Conference Center University of Maryland University College (UMUC)
3501 University Blvd. East, Adelphi, Maryland
The committees will discuss the benefits and risks of ORTHO EVRA (norelgestromin/ethinyl estradiol transdermal system), marketed by Janssen Pharmaceuticals, Inc., for the prevention of pregnancy. Specifically, the committees will discuss the possibly increased risk of thrombotic (blood clots) and thromboembolic events (blood clots that can break loose and move within the circulatory system) in users of ORTHO EVRA compared to women who use commonly prescribed birth control pills, as suggested by postmarketing studies.
View December 9th Meeting Announcement
HHS Highlights
NIH Interdisciplinary Women’s Health Research Symposium
The NIH Office of Research on Women’s Health will hold the Eighth Annual Interdisciplinary Women’s Health Research Symposium on November 17, 2011 at the NIH Bethesda Campus. The symposium will feature scientific advances from two ORWH-sponsored initiatives: 1) Building Interdisciplinary Research Careers in Women's Health (BIRCWH); and 2) Specialized Centers of Research (SCOR) on Sex and Gender Factors Affecting Women's Health.
To register for this free symposium or for more information, visit:
***************************
Women and the Affordable Care Act
Women have unique health care needs, and often make health care decisions for their families. The health care law protects women by providing insurance options, covering preventive services, and lowering costs.
To Learn More:
Women:
http://www.healthcare.gov/news/factsheets/2011/08/women.html
Pregnant Women: http://www.healthcare.gov/news/factsheets/2011/08/pregnant-women.html
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:
National Conference on Correctional Healthcare, October 15-19– Baltimore, MD
Pennsylvania Conference for Women, October 25– Philadelphia, PA
American Public Health Association, October 29 – November 2 – Washington, DC
National Congress of American Indians, October 31 – Nov 4, Portland, OR
US Conference on AIDS, November 10-13 – Chicago, IL
*************************************
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 |  |
