Office of Women's Health UPDATE, September-October 2003

Director's Message
Susan F. Wood, Ph.D.

Menopausal Hormone Therapy Campaign

Earlier this month, the FDA, over 20 national organizations, and several agencies within the Department of Health and Human Services launched a Menopause and Hormones Information Campaign at a Press Conference on Capitol Hill. The goal of this campaign is to provide women with clear information and tools that they can use in deciding about the use of hormone therapy at menopause.

In January of this year, FDA revised menopausal hormone therapy product labeling to reflect new safety precautions emphasizing that these products should be used at the lowest dose that helps and for the shortest time needed. However, more than ten million women currently use hormones, and there is still uncertainty about what this new safety information really means.

In February, Chairman Henry Bonilla, Rep. Rosa DeLauro and the House Appropriations Committee requested that FDA's Office of Women's Health, Center for Drug Evaluation Research, partner HHS agencies and many outside organizations develop materials to help clarify the issues surrounding the safe use of menopausal hormone therapy for American women.

The main tools of this campaign are a menopause and hormones fact sheet, and a purse guide that provides questions that can be discussed with a health professional. These materials are available in both English and Spanish from the National Women's Information Center (NWHIC) at www.4woman.gov and through FDA, NIH and AHRQ websites.

FDA/OWH awards 5-Year Women's Health Research Contracts

These Women's Health Research Contracts build upon the strengths of past collaborations with the Department of Health and Human Service's Center's of Excellence in Women's Health while facilitating the contracting process for conducting clinical research studies on women's health. In June, FDA's OWH solicited proposals from women's health research networks capable of conducting human clinical studies. Ten institutions responded to the solicitation and seven contracts were awarded to Boston University, Indiana University, Tulane University, University of Illinois at Chicago, University of Wisconsin, University of Arizona, and University of Washington. These contractors will conduct studies in response to specific task orders issued over the next five years. Ideas for the task orders may originate from FDA or the investigators. The objective of each task order will be to provide information to assist FDA OWH in advancing its regulatory science research program.

The first task order was awarded to the University of Arizona to determine if pregnancy changes the activity of the antidepressant medication, sertraline. Marked differences in the metabolism of sertraline exist. Most women clear the drugs very quickly but a small percentage of women do not. The Arizona study will enroll pregnant and nonpregnant Native American women. The clearance of sertraline has not been studied in pregnancy or in the Native American population.

Hollings Center, South Carolina

On September 27, 2003, the South Carolina Statewide Cancer Outreach Initiative will kickoff a major cancer awareness, education and support program in Charleston, SC. Representatives from the FDA, including Commissioner McClellan, and South Carolina Senator Hollings are planning to attend. The program is a collaborative effort with the FDA/Office of Women's Health, The Breast Cancer Resource Committee, the American Cancer Society, as well as an exhaustive group of community organizations. The statewide education program will include all cancers with an emphasis on breast cancer. The focus will be to increase utilization of mammography screening, particularly among minority and underserved populations.

Update on Recent DIDR Activities

The OWH developed FY 2003 Congressional Report was delivered to Congress August 29, 2003. The report described progress made toward the development of FDA's Demographic Information and Data Repository (DIDR). These initiatives are focused on improving the FDA's ability to assess clinical data, product labels, and product reviews for inclusion of women and other demographic groups in clinical trials.

Recent DIDR activities include the successful passing of the Structured Product Label (SPL) at the Health Level 7 Committee Level. The SPL specifies the electronic structure for the regulatory requirements and content of product labeling, including gender information. The second level ballot for the SPL at Health Level 7 should take place in this fall. If there are no significant changes to the SPL, the next ballot would be a Membership Level ballot. Passage at the Membership Level will result in the development of an American National Standards Institute accredited standard for FDA product information.

FDA's response to Food, Dietary Supplement, and Cosmetic Adverse Events

This past summer, the Center for Food Safety and Applied Nutrition (CFSAN) launched its Adverse Event Reporting System (CAERS) to help track and monitor adverse events related to foods, dietary supplements, cosmetics, food additives, and color additives. CAERS is part of an agency-wide effort to improve the reporting of adverse events to the FDA. To report an emergency call: 1-866-300-4374 or 301-796-8240. To report a non-emergency adverse event, contact the FDA district office nearest you.

FDA Expands Food Labels

In July, FDA announced a new regulation requiring food manufacturers to list trans-fat content on the food label. Trans fatty acids increase the risk of heart disease---the number one killer of women. Information can be found at www.fda.gov.

Approvals

Seasonale, a new birth control pill, was approved to reduce the frequency of a woman's period from every month to four times a year.

Crestor, (rosuvastatin) approved as a cholesterol-lowering drug. Lowering cholesterol is a key to reducing the risk of heart disease.

The INDEPENDENCE iBOT 3000 Mobility System, approved as a battery-powered wheelchair that relies on a computerized system of sensors, gyroscopes and electric motors to allow indoor and outdoor use on stairs, as well as on level and uneven surfaces. It represents a breakthrough in technology with the potential to benefit people with disabilities, and the estimated 2 million people who use wheelchairs.

Recalls & Safety Alerts

July 2003: Barr Laboratories recalled three batches of the 28-day oral contraceptive, Nortel 7/7/7.

August 2003: The FDA is announcing the addition of new safety information and warnings to the labeling for the drug Salmeterol, a long-acting bronchodilator used to treat asthma and chronic obstructive pulmonary disease (COPD). Serevent Inhalation, Aerosol, Serevent Diskus, and Advair Diskus are affected by the warning. FDA strongly advises patients that they should NOT stop taking these products without first talking to their physicians.

Other health advisories can be found on the FDA website at: 

Advisory Committee Meetings

Reproductive Drugs Advisory Committee, September 29-30, 2003, Gaithersburg Hilton, Maryland
Endocrinologic and Metabolic Drugs Advisory Committee, October 7, 2003, Holiday Inn Bethesda, Maryland
General & Plastic Surgery Devices of the Medical Devices Advisory Panel, October 14-15, 2003 Gaithersburg Marriott, Maryland

Conferences & Meetings

AOA: September 21-23, 2003 -- Orlando, FL
Georgia Women's Conference -- September 22-23, 2003- Atlanta, GA
NANAINA: September 25-28, 2003 -- Salt Lake City, UT
Tenth Annual Interdisciplinary Women's Health Research Symposium Sex and Rx: A Symposium on Women and Medications: October 24, 2003 -- Baltimore, MD
American Dietetic Assoc.: October 25-28, 2003 -- San Antonio, TX
APHA: November 15-19, 2003 -- San Francisco, CA

Some National Health Observances: September

Gynecologic Cancer Awareness Month

Healthy Aging Month

National Cholesterol Education Month

Ovarian Cancer Awareness Month

Please contact OWH if you know of national organizations that should be added to our list:

Food and Drug Administration
Office of Women's Health
5600 Fishers Lane, Room 16-65
Rockville, MD 20857
Phone: 301-827-0350
Fax: 301-827-0926