Office of Women's Health UPDATE, March-April 2005
OWH Celebrates a Milestone
This year marks the 10th anniversary of the Food and Drug Administration (FDA) Office of Women's Health (OWH). We have had many successes during the past decade. While our mission remains the same, we begin the next phase in the progression of OWH with a new look. The new OWH logo features women from an array of cultural backgrounds. Each woman represents a different regulatory function of the FDA: medical devices, drugs, biological and radiological products, cosmetics, and food. This new logo will be featured on our traveling exhibits and outreach materials. With our new look and renewed focus, we will continue to fund seminal research studies and outreach efforts to protect and advance the health of the nation's women.
OWH Welcomes New Staff Member
Alison Lemon joins OWH as a Public Health Educator. She brings an expertise in designing low-literacy health education materials. Alison received her masters in health science from Johns Hopkins University in 2001. She also holds a BA in public relations and psychology from Syracuse University. Alison has previously worked with the FDA as both an intern and a contractor. In addition to her role at FDA, Alison is an adjunct professor at George Washington University. She is also a certified yoga and Pilates instructor.
Drug Safety Board
On February 15, 2005, FDA announced the formation of a new Drug Safety Oversight Board to manage drug safety issues for the Agency. The board will consist of FDA staff as well as experts from other Health and Human Services agencies. The new board will also provide up-to-date safety information to health providers and consumers.
More information about the Drug Safety Oversight Board.
FDA and the National Cancer Institute have created a new Research and Regulatory Review Fellowship to train researchers in molecular oncology. The Fellowships will include four different training programs for scientists and physicians working with molecular oncology products. The programs aim to bridge the gap between scientific research and the regulatory process.
More information about the FDA/NCI fellowship.
State-of-the-Science Conference on Menopause
The National Institutes of Health convened a State-of-the-Science Conference on the Management of Menopause-Related Symptoms on March 21-23, 2005 in Bethesda, MD. After weighing all of the scientific evidence, an independent 12-member panel presented the following conclusions:
Menopause is the permanent cessation of menstrual periods that occurs naturally around age 52. Many women have few or no symptoms; these women are not in need of medical treatment.
Premenopausal or perimenopausual women who have menopause induced by surgery, chemotherapy, or radiation are more like to experience bothersome and even disabling symptoms. These women deserve safe and effective treatment.
It is difficult to determine which symptoms are truly associated with menopause as opposed to aging.
Vasomotor symptoms are reported with high frequency. Estrogen, either by itself or with progestins, is the most consistently effective therapy for these symptoms. However, the Women's Health Initiative Study identified a defined risk associated with these therapies. Decision making for women regarding treatment for menopausal symptoms requires personal knowledge and balancing of these risks.
There are many potential alternatives to estrogen. However, their effectiveness and long-term safety need to be studied in rigorous clinical trials in diverse populations of women.
To address the charge to this panel, much more research is needed to clearly define the natural history of menopause, associated symptoms, and effective and safe treatments for bothersome symptoms.
The state of the science in management of menopausal symptoms should be reassessed periodically.
Additional information about the conference.
Menopause and Hormones Campaign
The communications plan for the Menopause and Hormones information campaign is now in full swing! Spearheaded by The Media Network, the campaign has included print, radio, and Internet advertisements as well as community outreach activities. Over 26,000 menopause kits were distributed through the HHS National Women's Health Information Center. English language print advertisements were placed in national publications with an audience reach of approximately 5.9 million people. Additionally, English and Spanish language fact sheets and discussion guides were distributed through FDA partners including state women's health coordinators and state FDA public affairs specialists. State level e-mail campaigns resulted in 17,796 total hits to the menopause website, and a FDA editorial on menopause also appeared in 148 newspapers in 14 different states.
All campaign related materials are available for FDA partners to download and use.
Diabetes Conference in the US Virgin Islands
OWH sponsored the Women and Diabetes Symposium for Health Professionals on February 23, 2005 and February 25, 2005 in St. Thomas and St. Croix, respectively. The conference was coordinated by the San Juan District Public Affairs Specialists, Ruth Marcano and Nilda Villegas, in partnership with the Puerto Rico Diabetes Association, the U.S. Virgin Islands' Diabetes Program of the Department of Health, the University of Puerto Rico's Women's Health Center, and others. The conference offered expert speakers from the Centers for Disease Control in Atlanta as well as universities and health professional groups from throughout the region. The symposium was a groundbreaking initiative that addressed issues relating to the increasing prevalence of diabetes in the Caribbean. Approximately 200 health care providers and educators attended the conferences.
Southern Women's Show
Acting Assistant Commissioner for Women's Health, Marsha Henderson, and Atlanta Public Affairs Specialist, JoAnn Pittman, participated in the 2nd Annual Southern Women's Show in Savannah, Georgia on February 17th-19, 2005. A cooking presentation was conducted with chefs from the Kroger national grocery chain. The presentation discussed the "Cooking for Women" initiative that aims to provide consumers with food safety and health information. The cooking demonstration featured dishes from the Office of Women's Health diabetes recipe cards. Kroger staff provided participants with food samples, and FDA provided door prizes to encourage healthy lifestyle behavior. More than 600 participated in the conference. The diabetes recipe cards and brochures featured at this event can be ordered in English or Spanish by calling 1-888-8PUEBLO.
B-Sure brand One-Step Home Pregnancy Test
-- On March 25, 2005, Harmony Brands, Oak Park, Michigan, a national distributor of health, cosmetic and other consumer products, voluntarily recalled its B-Sure brand One-Step Home Pregnancy Test, because its safety and efficacy can no longer be assured. The tests can be identified by the product label notation "B-sure" pregnancy test. Additional information identifying the product can be found on the Harmony Brands Web site.
-- The FDA is advising that some soft cheeses made with raw milk present a health risk, especially to high-risk groups, such as pregnant women, newborns, older adults, and people with weakened immune systems. Such raw milk soft cheeses can cause several serious infectious diseases including listeriosis, brucellosis, salmonellosis and tuberculosis. Recently, cases of tuberculosis in New York City have been linked to consumption of queso fresco style cheeses, either imported from Mexico or consumed in Mexico, contaminated with Mycobacterium bovis, the causative agent.
-- The FDA issued a public health advisory, a patient information sheet, and a corresponding healthcare professional information sheet further explaining the identified risks and benefits of Crestor (Rosuvastatin calcium), a cholesterol-lowering drug. FDA is providing up-to-date information about the risk of rhabdomyolysis (serious muscle damage) in patients taking Crestor as well as other statin drugs. This is a well-known, rare adverse effect of all statins. Review of data available to date from controlled trials as well as the latest post-marketing safety information indicates that patients taking recommended doses of Crestor have a similar risk of rhabdomyolysis as patients on other statin cholesterol treatments. The revised labeling notes that this may be particularly important for treating Asian American patients, since clinical trial data suggest that they (along with patients on cyclosporine or patients with severe renal insufficiency) may have higher drug levels and therefore be at greater risk for muscle injury due to Crestor than the general population.
-- The FDA issued a public health advisory to inform patients and health care providers about the suspended marketing of Tysabri (nataluzimab) while the Agency and the manufacturer evaluate two serious adverse events reported with its use. FDA received a report from Biogen Idec, the manufacturer of Tysabri, of one confirmed fatal case and one possible case of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri for MS. FDA was given preliminary information about these cases by Biogen, Idec on February 18, 2005. Details became available to FDA the next week. PML is a rare, serious progressive neurologic disease usually occurring in immunosuppressed patients. There is no known effective treatment for PML. Although the relationship between Tysabri and PML is not known at this time, because of the serious and often fatal nature of PML, FDA concurred with the company that the drug be voluntarily withdrawn from marketing and that the use of Tysabri in clinical trials be suspended until more is known.
FDA Advisory Committee Meetings
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee - CDRH
Topic: Silicone Gel-Filled Breast Prostheses
Date: April 11-13, 2005
Location: Hilton - Washington, DC
Advisory Committee Meeting information
Draft Guidance for Industry and FDA Staff on Saline, Silicone Gel, and Alternative Implants
CDRH Breast Implant information page
National Osteoporosis Foundation
April 6-10, 2005
Wellness & Women XII Conference
Native Women: Heartbeat of Our Nations
April 3-7, 2005
San Diego, CA
Priester National Extension Health Conference
April 12-15, 2005
FDA Public Symposium -- Personalizing Your Healthcare -- The Best Consumer is an Educated Consumer
April 26, 2005
2005 FDA Science Forum
April 27-28, 2005