OWH News
February 2012
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Message from the Director
In a recent FDAVoice blogpost, Commissioner Margaret Hamburg spoke of the ways “the tragedy of thalidomide led to changes that strengthened both the regulatory and scientific environment for medical product development and review”. The tragedy set a precedent for efforts to promote and protect the health of all Americans. Changes to FDA regulations and research practices have dramatically increased clinical trials data collection and analyses leading to scientific advances benefiting the health of both women and men. The Agency and our regulated industries have come a long way since women of reproductive potential were excluded from trials following the negative outcomes associated with thalidomide use. However, much is still unknown about sex differences in the safety and efficacy of FDA-regulated medical products. Fifty years after thalidomide, the FDA Office of Women’s Health continues to advocate within and outside the Agency for women’s health research and educational outreach. I encourage you to read this update to learn more about our ongoing efforts.
Marsha Henderson, MRCP
Assistant Commissioner for Women’s Health
OWH Research
OWH Research on Women and Heart Disease
Heart disease is the leading cause of death for all adults. However, the diagnosis and treatment of cardiovascular diseases can be different for women versus men. Women, for example, experience higher bleeding rates during percutaneous coronary interventions (PCI) performed through femoral arterial access. Women are also more susceptible to drug-induced cardiac arrhythmias.
Check the link below to learn more about OWH research efforts to both improve regulatory decision-making and advance scientific knowledge on sex differences in the safety and efficacy of FDA-regulated medical products for cardiovascular diseases.
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Intramural Research Funding
The OWH Intramural Research Program has provided year 2 funding for 17 research projects by FDA scientists. The research projects address topics such as nanotechnology and women’s health, sex differences in polymer degradation in drug eluting stents, the effects of BMI/body weight on the effectiveness of hormonal contraceptives, and the development of biomarkers for the detection and treatment of breast cancer.
Selections for the new 2012 intramural research projects will be announced later this spring.
Learn More about OWH Research Projects:
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OWH sponsors Stakeholder Meeting for Nursing Groups
In October, OWH collaborated with AWHONN to sponsor a Nurse Stakeholders meeting at AWHONN Headquarters in Washington DC. Leaders from nineteen national nursing organizations met to discuss mutual women's health priorities and hear updates on OWH research and outreach initiatives. In addition, OWH shared resources for patient education including ¡Nunca Más! - the safe medication use novela series for Hispanic women.
Learn More about collaborating with OWH:
OWH Outreach
Pregnancy Registry Outreach Materials Now Available
Many women take medicines for chronic conditions like diabetes, epilepsy, depression, and asthma that start or get worse during pregnancy. Other women take medicines before they realize they are pregnant.
OWH is expanding its efforts to educate women about medication use during pregnancy. New outreach cards and other educational materials are now available in bulk free of charge for consumers and health professionals. The materials raise awareness about the OWH pregnancy exposure registry web portal and other FDA resources on medicine and pregnancy.
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OWH Supports Local Outreach by FDA Field Staff
OWH has funded 16 FDA Public Affairs Specialists (PAS) in cities and regions around the country. Funding enables the PAS to educate consumers and health professionals about OWH initiatives by speaking and exhibiting at local, state and regional conferences and meeting with key partner groups. This year's projects have a special emphasis on the
¡Nunca Más! telenovelas and
Pregnancy Exposure Registries website.
View a list of FDA Public Affairs Specialists:
http://www.fda.gov/AboutFDA/ContactFDA/FindanOfficeorStaffMember/FDAPublicAffairsSpecialists/default.htm
FDA Highlights
FDA Newsroom
FDA launches New Blog - ‘FDA Voice’
FDA Voice is the Agency’s official blog brought to you from FDA's senior leadership and staff stationed in the US and abroad. FDA Voice shares news, background, announcements and other information about the work done at the FDA on behalf of the American public. Since the first blog in December, FDA Voice has covered issues such as Gulf Seafood Safety, Device Regulation, PEPFAR, and acetaminophen dosing for infants.
FDA Meetings
Reproductive Health Drugs Advisory Committee
Date and Time: April 5, 2012 from 8 a.m. to 4:30 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Avenue, Building 31, Room 1503
The Committee will discuss the benefits and risks of mirabegron (YM178), under New Drug Application (NDA) 202611, submitted by Astellas Pharma Global Development Inc. for the proposed indication of treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Mirabegron is a beta-3-adrenoceptor (AR) agonist and is a new molecular entity. The benefit/risk discussion will focus on the adequacy of the demonstration of efficacy and safety in the treatment of OAB.
View Meeting Announcement
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:
- Partnerships in Clinical Trials, March 3-5– Orlando, FL
- American Pharmacists Association, March 9-12 – New Orleans, LA
- Public Library Association, March 14-16– Philadelphia, PA
- Women’s Health 2012: 20th Annual Congress, March 16-18, Washington, DC
- Planned Parenthood National Conference, March 21-23 – Portland, OR
- Aging in America, March 28 – April 1 – Washington, DC
- American Medical Women’s Association, April 12 - 16 – Miami, FL
- National Rural Health Association, April 17-20 – Denver, CO
Want more information from the FDA Office of Women’s Health?
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Please share this update with your network, members, constituents, and community.
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