OWH UPDATE, March 2000

Letter from Jonca Bull, M.D., Acting Director

Welcome to our first issue of the FDA Office of Women's Health (OWH) Update. Founded in 1994, our office serves as a focal point for the agency in women's health issues in regulatory science and in the agency's outreach to women consumers by providing timely information on agency activities of importance to our stakeholders.

Our core program areas are in research to expand the scientific base, outreach to educate consumers on the safe use of medical products, and oversight and advocacy of women's health issues within the agency. Through this Update, we hope to better inform consumers and women's health advocates about FDA and it's role in public health protection. All issues of this publication are available online in the OWH Update Archive.

Meet our staff:
Marsha Henderson, MCRP, Health Programs Manager
Margaret Miller, PhD, DBAT, Science Program Manager
Kennerly Chapman, Project Officer
Christine Everett, MPH, Program Analyst
Patti Bradfield and Deborah Douglas, Administrative Staff.

Take Time To Care: Great Success

Only the response of the target audience measures the true effectiveness of a public education campaign. In the case of Women's Health: Take Time to Care (TTTC), the audience has declared the campaign a near perfect success. Last October, Merck-Medco Managed Care, LLC sent 1 million of its customers the campaign's centerpiece "My Medicines" brochure along with a survey to assess recipients' satisfaction. Women responded with an overwhelming approval rating of 99.1%.

The survey results were particularly encouraging to the many partners who carried out the nationwide campaign. Developed by the U.S. Food and Drug Administration's Office of Women's Health (OWH), TTTC has for three years leveraged the resources of national non-profit organizations, businesses, associations, and women's and ethnic groups to deliver an urgent message to women nationwide: "Use Medicines Wisely."

Colorful and compact, "My Medicines" includes tips for taking medicines correctly as well as a record card for tracking medicine use. Like TTTC, the brochure is designed primarily for women, because they often manage medications for their whole family, and women over 45 use more medication than any other group. Throughout TTTC's three-year campaign, OWH and its partners distributed 6 million brochures.

The "My Medicines" brochure is available in English, Spanish and many other languages at our web site at http://www.fda.gov/womens/tttc.html. Consumers and groups may order 1-500 copies in English or Spanish by calling 1-888-8PUEBLO.

OWH's Scientific Research Program

To help the agency meet it's mission and to promote women's health, FDA's Office of Women's Health (OWH) initiated an intramural scientific research program in 1994. This program funds research projects aimed at improving the agency's policies and decisions on women's health issues. Over the past six years, the program has funded approximately 100 high priority women's health projects in FDA and spent about $8.5 million dollars. Projects include basic and clinical research on autoimmune disease, breast implants, cancer, cardiovascular disease, contraceptives, cosmetics, developmental and reproductive toxicology, gender differences, sexually transmitted infections, nutrition, osteoporosis and pregnancy. In addition, the program has funded several projects designed to examine gender differences in adverse events that occur with the use of medical products in the marketplace.

Examples of recently completed projects of previous years include:

• Publication of an OWH funded study in the American Journal of Clinical Nutrition, found that mothers of children with Down syndrome show biochemical and genetic evidence of impaired folate metabolism and suggested that fortification of foods with folate may decrease the incidence or severity of this condition.
• A study on ultrasonic measurements of bone suggesting that this technique offers a low cost, simple, quick and portable means of assessing for osteoporosis without ionizing radiation.
• A study on barrier contraceptives resulted in two laboratory methods for assessing the integrity of these medical devices. Assessment of integrity is imperative to determining the level of protection against sexually transmitted diseases and pregnancy.

We'll include future findings in subsequent OWH Updates.

What's Happening at the FDA

Buying Medical Products Online: Important

The FDA now offers a web site with tips to consumers who buy health products online. With hundreds of drug-dispensing web sites popping up on the Internet everyday, it can be difficult for consumers to tell which sites are legitimate. Some sites are especially confusing when they look very professional and promise deep discounts or a minimum of hassles. For more information, go to http://www.fda.gov/oc/buyonline.

New Warning on Diabetes and Chinese Herbs

The FDA warns that people with diabetes should avoid five brands of Chinese herbal products because they illegally contain drugs that could drop blood sugars dangerously low. The FDA warning comes after health officials in California discovered that the pills, which manufacturers say contain only herbs, also contain the prescription diabetes drugs glyburide and phenformin. The affected products are: Diabetes Hypoglucose Capsules, sold by Chinese Angel Health Care Products of Santa Monica, Calif.; Pearl Hypoglycemic Capsules, imported by Sino American Health Products Inc., of Torrance, Calif.; Tongyitang Diabetes Angel Pearl Hypoglycemic Capsules and Tongyitang Diabetes Angel Hypoglycemic Capsules, sold by Sino American, and Zhen Qi Capsules, sold by Sino American. Chinese Angel and Sino American have agreed to recall the products, which may be returned to place of purchase for a refund.

New Approvals of Special Interest to Women

• The FDA approved alosetron hydrochloride, (Lotronex) a new medication to treat irritable bowel syndrome (IBS) in women whose pre-dominant bowel symptom is diarrhea. The condition is three times more common in women than men. Like existing IBS therapies, alosetron treats the symptoms associated with the syndrome. Although how the drug works is not completely understood, alosetron slows intestinal movement and may provide relief by targeting the underlying neurological activity associated with the condition. For more information, go to http://www.fda.gov/bbs/topics/ANSWERS/ANS01003.html
• FDA has approved the Senographe 2000D, the first mammography system that produces digital images on a solid state receptor instead of analog images on a radiographic film. Film/screen (analog) mammography along with physical examination and breast self-examination is the standard method for breast cancer screening in women. From the patient's point of view, mammography with a digital system is essentially the same as with the film/ screen system. The evidence presented so far does not show that the digital images are more helpful in finding cancer than the analog/film images. More information can be found at this URL: http://www.fda.gov/cdrh/pdf/p990066.html.

Public Meetings

1. "Science of Safety" was the theme for the 2000 FDA Science Forum held February 14-15 at the Washington Convention Center in Washington, D.C. Dr. Jonca Bull of OWH led a breakout session titled "New Scientific Perspectives: Women's Health and the Science of Gender Differences."
2. On March 1-3, 2000, the CDRH's General and Surgical Panel met to discuss the safety of saline-filled breast implants. The panel considered data submitted by three companies. The panel recommended two of them for approval with conditions to perform additional studies. FDA will consider the panel's recommendation and make a final decision.
3. The FDA has announced two public meetings to discuss ways in which FDA can better leverage its expertise and resources by working with outside organizations. These collaborations are intended to have a larger net public health benefit to the American public than would be possible if FDA worked alone. Participants may include academia, consumer groups, scientific experts, industry, public health providers, states, and other government agencies.

The five proposed initiatives include:

• Safety reviewed for new products - Safety Assurance in Clinical Trials
• Assuring industry compliance with safety regulations--Gene therapy, Human Cellular and Tissue Based Products
• Patient/consumer education on the safe use of products - Risk Management
• Inspections--Internet
• Safety-related research--NCTR identified opportunity

The meetings will be held on March 23 in Stanford, CA and April 12 in Durham, NC. For general information contact: Virginia Cox at 301-827-3409 or vcox@ oc.fda.gov.

• On March 28-29, 2000, the Pregnancy Labeling Subcommittee of the Advisory Committee for Reproductive Health Drugs will meet in Gaithersburg, MD. For more information, contact: Jayne E. Peterson or Robin M. Spencer, at 301-827-7001 or e-mail: petersonj@ cder.fda.gov, or call the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12537.
• A public meeting on safety issues associated with dietary supplement use during pregnancy will be held on March 30, 2000 in Gaithersburg, MD. The purpose of this meeting is to obtain public comment on safety concerns that have been raised regarding structure/ function claims for dietary supplements used during pregnancy. For more information, contact Rose Cunningham, Center for Drug Evaluation and Research, FDA (301) 594-5468 or e-mail: sfp15reg@cder.fda.gov.

Advisory Committees

Information on upcoming FDA advisory committee meetings are available through the FDA Advisory Committee Information Line at 1-800-741-8138 (301-443-0572 in the Washington, DC area), and media print 301-827-6242.

New Publication!

At the start of the year 2000, it is with great pleasure that we announce our newest publication, FDA Milestones in Women's Health: Looking Back as We Move Into the New Millennium.

This special booklet guides the reader through significant moments and movements in public health history that effectively improved women's health throughout the United States. While we are looking forward to all the important public health strides we will make in the 21st century, reading this booklet is a good reminder of how far we have come in the last 100 years.

To view the document online, go to our web site. If you have upcoming meetings or conferences where this booklet would be useful, please call the Office of Women's Health at (301) 827-0350 for hard copies.

New Look for OWH Web Site!

In April, please take a moment to check out the newly redesigned OWH web site at www.fda.gov/womens/. Its fresh new look will allow visitors to learn more about OWH, easily access OWH publications and link to information about various women's health topics.

Please contact OWH at 301-827-0350 if you know of groups who should be added to our fax list.

Food and Drug Administration
Office of Women's Health
5600 Fishers Lane, HF-8, Room 15-61
Rockville, MD 20857
(301) 827-0350 or fax (301) 827-0926
www.fda.gov/womens/

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