Office of Women's Health Update, December 2000
Welcome to the FDA Office of Women's Health Update. This summary highlights the activities of our outreach and science programs. Read on for the latest information about regulatory actions and upcoming meetings of interest to women's health. All issues of this publication are available online in the OWH Update Archive. For additional information, please check out our Website.
FDA Announces New OWH Director
This November, Dr. Susan F. Wood, Ph.D. was named as the new director of OWH. Previously, Dr. Wood was the Director for Policy and Program Development at the U.S. Department of Health and Human Services' Office on Women's Health, where she led the development of policy for the Office and recommended action for the Assistant Secretary for Health and the Secretary. She also coordinated the activities of the Public Health Service Coordinating Committee on Women's Health, and represented the Office in the areas of international health, reproductive health, legislation, and health care policy.
From 1990 to 1995, Dr. Wood worked for the Congressional Caucus for Women's Issues, an organization of Members of Congress dedicated to advancing legislation which promotes legal, economic, and health equity for women-co-chaired by Reps. Patricia Schroeder and Olympia Snowe. She was with the Caucus since 1990, when she shifted direction in her career from basic biological research to science and health policy. Initially as Science Advisor and later as Deputy Director to the Caucus, Dr. Wood helped develop and promote the Women's Health Equity Act, and was directly involved with many policy initiatives and legislative proposals which would advance biomedical research, women's health, family planning, and health care reform.
Prior to coming to Capitol Hill, Dr. Wood was a research scientist at the John Hopkins University School of Medicine, in the Department of Neuroscience, where her research focused on cellular mechanisms of sensory transduction. She received her Ph.D. in biology from Boston University Marine Program at the Marine Biological Laboratory in Woods Hole, MA, where she carried out basic research on the biochemistry of vision. She has published a number of research articles in scientific journals, as well as articles on health policy. Awards that Dr. Wood has received include the Boston University Marine Program Alumni Award, a National Research Service Award from the National Institute of Mental Health, the Biophysical Society Congressional Science Fellowship, a Woman of Achievement Award, the Assistant Secretary for Health's Superior Service Award, and the Keystone Award in Women's Health Research.
Breast Cancer Awareness Month In collaboration with the Center for Radiological Health, OWH sent a letter to all 10,000 certified mammography facilities inviting them to showcase the availability of our Mammography Today brochure and distribute a one-page abbreviated version of the brochure to inform patients about their new rights.
FDA Public Affairs Specialists in three cities (Houston, Dallas and Atlanta) conducted "Pink Ribbon Sunday" activities that encourage "women of color" to get screened. For example, in the city of Houston alone, 153 churches participated and reached about 110,000 people with FDA materials for which the PASs received the American Cancer Society's "Partner of Courage Award."
OWH developed a Breast Cancer "Early Detection Saves Lives" video tape to encourage churches to sponsor screening and educational activities. The video will be given to the Public Affairs Specialists, and the National Cancer Institute will distribute it through their clearinghouse.
New Partners Join Take Time To Care (TTTC) This past summer the American Pharmaceutical Association (APhA) Foundation and the National Wholesale Druggists' Association (NWDA) Healthcare Foundation worked together to promote TTTC using the medicine tips tent card. Approximately 43,000 tent cards have been mailed out in response to requests to hospital pharmacies across the country and will further the message that consumers have an important role to play in managing risks associated with medication use.
In December 2000, the Emergency Nurses Association announced its decision to adopt TTTC to its 25,000 members. The ENA will distribute the "My Medicines" brochure in emergency departments, hospital auxillaries, civic meetings and retirement homes.
PHS Centers of Excellence/FDA Pilot Partnership Initiative on Dietary Supplement Products
The OWH recently awarded six research contracts to the DHHS' Office on Women's Health's (OWH) National Centers of Excellence in Women's Health (CoE). The OWH funded projects were made to: Harvard University- to examine the effect of dietary soy with/without calcium in menopausal women; Wake Forest School of Medicine-to assess health outcomes and interactions of soy & gingko with drug products; University of Illinois at Chicago- to assess patterns of usage of dietary supplements in menopausal women; Indiana University School of Medicine- to evaluate the effects of St. John's Wort on the efficacy of oral contraceptives; University of Washington- to study the effects of phytoestrogens on menopausal symptoms in Asian & Caucasian women; and University of Michigan- to study the safety and effectiveness of weight loss products in combination with/without diet and exercise.
Significant Agency Actions Related to Women's Health
Ortho-Prefest for the treatment of moderate-to-severe vasomotor symptoms associated with menopause; treatment of vulvar and vaginal atrophy, and prevention of osteoporosis.
Aromasin for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.
Femhrt for the treatment of moderate to severe vasomotor symptoms associated with menopause and for prevention of osteoporosis.
Celexa for the treatment of depression.
Zoloft for depression, Obsessive Compulsive Disorder, and panic disorder.
Diltiazen HCl for the treatment of hypertension.
EString for the treatment of urogenital symptoms associated with post-menopausal atrophy of the vagina and/or the lower urinary tract.
Lantus for adult and pediatric Type 1 diabetes or adult Type 2 diabetic patients who require basal insulin for the control of hyperglycemia.
Mobic for relief of signs and symptoms of osteoarthritis.
Trivagizole for treatment of vaginal yeast infections.
Activella for women with intact uterus for the prevention of postmenopausal osteoporosis.
Nitrostat for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
Vivelle for the prevention of postmenopausal osteoporosis.
Depakote ER for the prophylaxis of migraine headaches in adults.
Kaletra for the treatment of HIV-1 infection in adults and pediatric patients age six months and older.
Atacand HCT for the treatment of hypertension.
TNKase for the reduction of mortality associated with acute myocardial infarction.
Mifeprex for the termination of early pregnancy, defined as 49 days or less, counting from the beginning of the last menstrual period.
Regulated Products- Safety Updates, Withdrawals
Glaxo Wellcome Withdraws Lotronex Glaxo Wellcome, of Research Triangle Park, NC, informed FDA that it will voluntarily withdraw Lotronex (alosetron hydrochloride) tablets from the market, a prescription medication approved to treat Irritable Bowel Syndrome (IBS) in women. Specifically, FDA has been concerned about reported cases of intestinal damage resulting from reduced blood flow to the intestine (ischemic colitis) and severely obstructed or ruptured bowels (complications of severe constipation), which resulted in five deaths. For more information on this subject, visit the Lotronex Information web page created by FDA's Center for Drug Evaluation and Research. The URL is www.fda.gov/cder/drug/infopage/lotronex/lotronex. htm.
FDA Issues Public Health Warning on Phenylpropanolamine FDA has requested that all drug companies discontinue marketing products containing phenylpropanolamine (PPA). PPA is an ingredient used in many over-the-counter (OTC) and prescription cough and cold medications as a decongestant and in OTC weight loss products. FDA issued a public health advisory concerning the risk of hemorrhagic stroke, or bleeding into the brain, associated with phenylpropanolamine hydrochloride. The increased risk of hemorrhagic stroke was detected among women, but men may also be at risk. Information about the history of phenylpropanolamine, the Public Health Advisory, and the stroke study results can be found on the FDA website at www.fda.gov/cder/drug/infopage/ppa/default.htm.
Tiratricol Warning The agency is again warning consumers of products marketed as dietary supplements that contain tiratricol, also known as triiodothyroacetic acid or TRIAC, a potent thyroid hormone that may cause serious health consequences including heart attacks and strokes. FDA urges all consumers to stop using such products immediately.
Other Agency Actions
FDA Public Health Advisory letter sent to Health Care Professionals regarding a drug interaction between St John's Wort and indinavir, a protease inhibitor.
Publication of the final rule "Investigational New Drug Applications; Amendment to Clinical Hold Regulations for Products Intended for Life-Threatening Diseases and Conditions."
Public Meeting on the safety of dietary supplements containing ephedrine alkaloids.
Mammography Quality Standards Act (MQSA)- Congress charged FDA with developing and implementing MQSA regulations. In FY 2000, States as Certifiers (SAC) proposed regulations were published.
On November 29-30, 2000, the FDA and CDC co-sponsored a workshop entitled, "Monitoring the risks of medications in pregnancy." The purpose of the meeting was to discuss a better way to collect information on adverse fetal outcomes due to drug use in pregnancy.
On December 4-5, 2000, the agency held a public meeting entitled, "Clinical Pharmacology during Pregnancy." The goals of the meeting were: To summarize the state of knowledge regarding clinical pharmacology in pregnancy; to raise awareness among clinician researchers and leaders about the need for clinical research and collaboration in this area; and to garner support for such research from health advocacy groups and others.
The Microbiology Devices Panel of the Medical Devices Advisory Committee met on December 8, 2000 to discuss and make recommendations on issues concerning the types of information necessary to determine the effectiveness of in vitro diagnostic devices that detect human papilloma virus (HPV) in women 30 years or older when these devices are used in conjunction with Pap smear to increase the effectiveness of Pap smear screening for cervical cancer, and without Pap smear to determine a woman's risk of cervical cancer. Additionally, the committee discussed and made recommendations on issues concerning the use of self-collection and alternative specimen sources for the above indications.
Oncology Drugs Advisory Committee
DATES AND TIMES: Dec. 13, 8:30 a.m. and Dec. 14, 8 a.m.
LOCATION: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., Bethesda, MD.
CONTACT: Karen M. Templeton-Somers, Center for Drug Evaluation and Research (HFD-21), 301-827-7001.
On Dec. 13, at 8:30 a.m. the committee discussed new drug application Femara (letrozole) Tablets, 2.5 mg, Novartis Pharmaceuticals Corp., indicated as first-line therapy in postmenopausal women with advanced breast cancer and histamine hydrochloride injection (1 mg/ml), Maxim Pharmaceuticals, Inc for adjunctive use with interleukin-2 (aldesleukin) in the treatment of adult patients with advanced metastatic melanoma that has metastasized to the liver
DATE AND TIME: December 13, 9:00 a.m. - 4:00 p.m.
LOCATION: Hubert H. Humphrey Building, Penthouse Conference Room, 200 Independence Avenue, S.W., Washington, D.C.
CONTACT: Karen Mahoney, Office of Consumer Affairs, at 301-827-439.
A discussion between senior FDA officials and consumers on key public health and consumer protection priorities for the Agency.