We began 2003 with renewed commitment and leadership. We look forward to working with Commissioner McClellan, as his priorities are critical to improving the health of all women.
Mark McClellan, M.D, Ph.D was sworn in as Commissioner to the Food and Drug Administration on November 14, 2002. Prior to joining FDA, Dr. McClellan was Associate Professor of Economics and Medicine at Stanford. During 2001 and 2002, Dr. McClellan served in the White House as a Member of the President's Council of Economic Advisers as well as functioning as a senior policy director for health care and related economic issues.
Since joining FDA, Dr. McClellan has established five strategic goals that will ensure the safety and efficacy of FDA-regulated products. We are very pleased to note that the priorities and activities of the FDA Office of Women's Health fit within the Commissioner's priorities and our work will help in moving each one of them forward.
His five priorities include:
Risk management--FDA will continue its focus on management of product risks through rigorous scientific analysis that weight the risk versus risk and risk-benefit associated with Agency actions. Through our work to develop the Demographic Information and Data Repository, the OWH is creating the tools necessary to reduce risks for women and other sub-populations.
Strong FDA--FDA will maintain a strong science-based organization to support its risk management responsibilities. Research identified and supported by the FDA OWH helps fill the gaps in regulatory research. In addition, we are working with NIH to develop a science-based course on sex and gender differences to provide the latest science to FDA reviewers.
Counterterrorism--FDA will assist in countering the terrorist threat through preparations such as strengthened product monitoring infrastructure and emergency preparedness plans, and rapid and appropriate responses in the event of an actual attack. The FDA OWH has funded groundbreaking research on pregnant women, the elderly and children, in order to collect data on the safety and effectiveness of treatments for bioterrorism.
Consumer Information--FDA will provide information to consumers, health professionals, and other constituencies that will enable them to make prudent decisions regarding the use of FDA-regulated products. Our award-winning outreach programs, ranging from "Pink Ribbon Sunday" to "Take Time to Care...About Diabetes", will continue to work in partnership with national organizations to bring important health messages to millions of women and their families across the country.
Adverse Events and Medical Errors--FDA will contribute to the reduction of adverse events and medical errors through enhanced reporting capability, strengthened problem analysis, and appropriate risk management strategies to address the problem. The first Take Time To Care Campaign, "Use Medicines Wisely" brings home the important message of safe medication use and provides tools for women and their health care providers to reduce medical errors and improve patient safety.
In January, 2003, the FDA approved new prescribing and patient information for certain estrogens (with and without progestins) for use by postmenopausal women. This labeling takes into account information from a large clinical study in women (the Women's Health Initiative) that showed that the overall health risks of taking Prempro (an estrogen plus progestin product) exceeded the benefits of the drug, especially for long-term use. The FDA action and the Women's Health Initiative results are further described on our Website and www.4woman.gov. The main change to the prescribing and patient information for estrogens (with or without progestins) used in postmenopausal women is the clear message that these products do not appear to protect women from cardiovascular disease and they do have side effects including increased risk of breast cancer and blood clots.
The FDA has issued guidance to all manufacturers of estrogen (with or without progestin) products for postmenopausal women requesting similar changes for all such products. The FDA has also issued new guidance to manufacturers about clinical trial requirements for new products used for symptoms of the menopause. These guidances can be found on our Website. Manufacturers and any interested persons are encouraged to comment on these documents. Information for submitting comments about these guidance documents is provided at the website.
Recognizing that many pregnancy-related medical complications affect the long-term health of women, federal agencies within the Department of Health and Human Services have held a series of strategic planning meetings to identify gaps in knowledge concerning maternal health and discuss research priorities for decreasing morbidity during and after pregnancy. Under the Safe Motherhood Initiative, several federal agencies have formed a collaboration to coordinate research and action to improve maternal health. The Safe Motherhood Initiative is being coordinated by the Public Health Service's Office on Women's Health and involves the Centers for Disease Control and Prevention, the Food and Drug Administration, the Health Resources and Services Administration, the National Institutes of Health (NIH), the Agency for Healthcare Research and Quality (AHRQ), and the Substance Abuse and Mental Health Services Administration (SAMHSA).
To address the first gap area identified under the Safe Motherhood Initiative, the federal agencies are working through the cross agency collaboration to address perinatal (pregnancy-related) depression. Perinatal depression remains an important public health issue and is relevant to the mission of many federal public health agencies. About ten to fifteen percent of pregnant and postpartum women experience depression, however many unanswered questions remain about screening, treatment and follow-up care for women who experience depression during and after their pregnancies. The U.S. Preventive Services Task Force (USPSTF) recommends screening adults for depression in clinical practices that have systems in place to assure accurate diagnosis, effective treatment, and follow-up Services. On March 3, 2003, the Public Health Service's Office of Women's Health (PHS OWH) will convene another meeting of the federal agencies aimed at identifying unanswered research issues, as well as to coordinate actions. FDA intends to fund research to determine if dosage adjustments are needed for antidepressant medication used in pregnant women.
Heart Disease
On February 14, 2003 FDA cleared for marketing a new laboratory blood test that will significantly increase the ability of doctors to rule out a heart attack when a person shows up at an emergency room with severe chest pains.
The test, the Albumin Cobalt Binding (ACB) Test, manufactured by Ischemia Technologies, Inc., of Arvada Colo., works by measuring how much cobalt is bound to the blood protein albumin. Changes in the structure of albumin occur in several illnesses, including heart attacks.
FDA cleared the test based on results of a study conducted by the manufacturer of more than 200 patients at high risk of heart attack who had severe chest pain. Sixty three percent of the patients had heart attacks. The ACB test helped to correctly identify the patients who did not have heart attacks.
The study showed that when the ACB test was used together with an ECG and a troponin test, physicians were 70 percent accurate in ruling out heart attack. With an ECG and troponin test alone, physicians were 50 percent accurate in ruling out a heart attack.
Diabetes
December 2002: The Food and Drug Administration (FDA) has cleared the first over-the-counter test that measures glycated hemoglobin in people with diabetes to help monitor how well they are managing their disease (glycemic control). The test, called Metrika A1c Now, is currently available by prescription only. Over-the-counter status means that the test can now be purchased without a prescription and used at home, with results on the spot, making it readily available to people with diabetes.
January 2003: Best Life International, Inc. is recalling all 100 tablet bottles of Ancom Anti-Hypertensive Compound Tablets, an unapproved new drug labeled to contain several prescription drug ingredients, including reserpine, diazepam, promethiazine, and hydrochlorothiazide. The sale of a product with this combination of ingredients poses possible serious health risks including sedation, depression, and potentially life-threatening abnormalities of the blood. Consumers who purchased Ancom Anti-Hypertensive Compound Tablets are urged to immediately discontinue use of the product and return it to the place of purchase for a full refund. Consumers with questions may contact the company at 787-832-3287.
FDA announced that an interim analysis of a large safety study of the approved asthma drug Serevent (salmeterol xinafoate) Inhalation Aerosol manufactured by Glaxo SmithKline suggests that the drug may be associated with an increased risk of life-threatening asthma episodes or asthma-related deaths, particularly in some patients. FDA emphasizes that based on available data, the benefits of Serevent for the asthma population continue to outweigh the risks and that the serious adverse events reported in the trial were rare. FDA strongly advises patients that they should NOT stop taking Serevent, or any other medication, for asthma or COPD, without first talking to their physicians. Abruptly stopping drugs for the treatment of asthma and COPD can result in serious exacerbations of these diseases that could be life-threatening. FDA further emphasizes that all asthma drugs, including Serevent, should be a given as a part of a comprehensive treatment plan that takes into account the patient's asthma severity and fully educates the patient in the disease and its proper treatment.
The Food and Drug Administration (FDA) proposed new warnings for the labels of over-the-counter vaginal contraceptive drugs that contain the spermicide nonoxynol 9. The warning would state that vaginal contraceptives containing nonoxynol 9 do not protect against infection from HIV (human immunodeficiency virus, the AIDS virus) or other sexually transmitted diseases (STDs). The proposed label warnings would also advise consumers that the use of vaginal contraceptives containing nonoxynol 9 can increase vaginal irritation, which may actually increase the possibility of transmitting the AIDS virus and other STDs from infected partners. FDA's proposed warning labeling for these vaginal contraceptive products containing nonoxynol 9 is being published in the Federal Register. The agency is requesting public comment, for 90 days, on the proposed labeling statements and on the most effective way to present this new warning. Interested parties may send written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Date and Time: The meeting will be held on March 4, 2003, from 9 a.m. to 4 p.m. and on March 5, 2003, from 8 a.m. to 5 p.m.; Holiday Inn, Kennedy Ballroom, 8777 Georgia Avenue, Silver Spring, MD.
Contact Person: Kathleen Reedy or LaNise Giles, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, Rm. 1093) Rockville, MD 20857, 301/827-7001, Fax: 301/827-6776.
Agenda: On March 4, 2003, the committee will hear a safety update on tnf alpha inhibitors; Humira (adalimumab), Abbott Laboratories; Remicade (infliximab) Centocor; and Enbrel (etanercept), Immunex. On March 5, 2003, the committee will discuss the approved product new drug application (NDA) 20-905, ARAVA, (leflunomide), Aventis Pharmaceuticals Inc., clinical data regarding efficacy for improvement in physical function in rheumatoid arthritis, as well as a safety update.
March is National MS Education and Awareness Month sponsored by the Multiple Sclerosis Foundation.
The Association of Maternal and Child Health Programs is holding its Annual 2003 Conference: "Mobilizing to Eliminate Health Disparities" in Arlington, VA, March 8-12. For more information, contact: Lori Whitehand 202-624-1749 FAX: 202-624-1766 E-mail: lwhitehand@amchp.org
National Hispanic Medical Association, March 21-23, 2003, Washington, DC
American Pharmaceutical Association, March 28-April 1, 2003, New Orleans, LA
Women's Health-2003 and Beyond (Mayo Clinic), April 24-26, 2003, Scottsdale, AZ
Community-Campus Partnerships for Health, April 26-29, 2003, San Diego, CA
National Breast Cancer Coalition, May 3-6, 2003, Washington, DC
Rural Minority Health Conference, May 12-16, 2003, Salt Lake City, UT
National Centers of Excellence in Women's Health, May 13-14, 2003, Vienna, VA
DHHS, Women and Diabetes Town Hall Meeting, May 20, 2003, Cannon Bldg., Caucus Room, Washington, D.C.
National Association of Chain Drugs Stores, June 7-10, 2003, San Diego, CA
American Diabetes Association, June 12-17, 2003, New Orleans, LA
Please contact OWH if you know of national organizations that should be added to our list.
All issues of this publication are available online in the OWH Update Archive.