Office of Women's Health UPDATE, February-March 2004
Susan F. Wood, Ph.D.
Introducing our New Staff ...
I am very pleased to announce the FDA-Office of Women's Health (OWH) has added new staff to help us move forward with our programs and activities. Each of them brings new skills and expertise to the OWH team.
Joe Kaczmarczyk, DO, MPH
Dr. Kaczmarczyk [pronounced Kaz-mar-check] a career Commissioned Officer in the US Public Health Service, is board certified in OB/GYN, occupational medicine, and holistic medicine. His career highlights include having been the senior medical advisor on the staff of the White House Commission on Complementary and Alternative Medicine Policy as well as President of the American College of Osteopathic Obstetricians and Gynecologists.
Pamela Scott, Ph.D- Candidate
Health Programs Coordinator
Prior to coming to OWH, Ms. Scott was a Mathematical Statistician in the FDA's Center for Devices and Radiological Health. Ms. Scott is currently a Ph.D. candidate in Epidemiology at Johns Hopkins University and her area of expertise and research interests are in clinical trials and research ethics.
Susana Perry, MS
Health Programs Coordinator
Ms. Perry has an MS in gerontology and extensive experience working with multiple HHS agencies. She has developed creative and innovative local, state and national programs focusing on under-served populations, with a health focus on elderly people and women.
Deborah L. Kallgren, B.S.
Health Programs Coordinator
Ms. Kallgren brings to the team over ten year's experience as a project manager within the FDA's Center for Drug Evaluation and Research. She was involved with the review management of AIDS drugs within the Division of AntiViral Drug Products, and, also assisted with the creation and development of CDER's Project Management and Certification training program.
New draft FDA guidance documents concerning breast implants, and direct to consumer (DTC) drug advertising are now available to the public. Because these topics have received ongoing media coverage and Agency discussion, there content is well known. However, given the importance of these issues to the health of women, we encourage your comment. To comment electronically, see the address provided below. Remarks may also be submitted by mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Please use the document number(s) to identify the guidance.
Draft Guidance for Industry and FDA Staff on Saline, Silicone Gel, and Alternative Breast Implants
In January, the Agency issued a new guidance calling for more pre-market information needed to ensure that breast implants are safe and effective. This revised draft reflects the agency's latest thinking on science and medicine pertaining to the safety of breast implants. New recommendations involve mechanical testing, modes and causes of rupture, clinical study information, post approval requirements, and labeling. You can view the revised draft guidance document on this Web site. Comments and suggestions should be submitted by April 12, 2004. Please use the document number (1239) to identify the guidance. [Comment electronically]
Draft Guidances on:
Presenting the Brief Summary in Direct-to Consumer Print Advertisements for Prescription Drugs
"Help-Seeking" and Other Disease Awareness Communications by Drug and Device Firms
DTC Broadcast Advertising of Medical Devices
Although DTC advertisements are promotional vehicles for prescription drugs and devices, for many consumers and patients, they also serve as first line sources of information on the products. In three recent draft DTC guidances, the Agency recommends that manufacturers assure that their product ads communicate important product use information to the public. Scientific terminology should be replaced with clear, easy to understand language. A "brief summary" of risk-benefit findings should be provided as well as awareness information about specific diseases or health conditions that does not promote a particular product, and, risk information should be included for restricted medical devices promoted in broadcast ads. Finally, because product information provided in commercials are not comprehensive, consumers are to be directed to a source where they can obtain additional data.
Comment electronically on the guidances.
Feb/March 2004 Take Time to Care About Diabetes National Campaign
In February/March 2004, the FDA Office of Women's Health will conduct the second year of its Take Time to Care ... About Diabetes (TTTC) campaign in 10 cities. The 10 cities participating include: Atlanta, GA, Detroit, MI, Oakland, CA, Orlando, FL, New Orleans, LA, Philadelphia, PA, San Antonio, TX, Las Vegas, NV, Minneapolis, MN, and San Juan, PR. If you are interested in participating in our campaign please visit our website for information on how to join. You may also obtain FREE copies of TTTC materials in both English and Spanish by calling 1-888-8-Pueblo.
Focus Group Results -- Menopause and Hormones Materials
The verdict is in ... three focus groups have confirmed that our menopausal hormone therapy materials are right on target. Overall results confirmed that the participants in both English and Spanish groups liked the format and content of the fact sheet and the purse guide. They found the fact sheet to be informative, answering questions other materials do not. With regard to the purse guide, participants felt it provided important questions about "what to ask", and "whom to ask" about menopause and hormone therapy. Suggestions were so minimal that we will continue to distribute our current stock. Please call 1888 8 Pueblo or 1-800-994-9662 for copies.
In the September/October edition of the OWH update, we summarized current efforts to launch a national "Menopause and Hormones" informational campaign. In March 2003, FDA, other Department of Health and Human Services agencies, and over 20 national health based organizations initiated work on this assignment. The objective was to raise awareness about the risks and benefits of hormone therapy for menopause, and lend clarity to the confusion surrounding this issue. A fact sheet and purse guide were created in a clear, easy to understand format to serve as tools to help women, in concert with their health professional, make an informed decision about the use of hormone therapy for menopausal symptoms. All materials were developed in both English and Spanish for the campaign kick-off last September.
In November - December, 2003 OWH used focus group to review and refine the format, design, and language of the above materials, and to receive input on a draft public service announcement that is currently under development. In order to best assess possible responses from women across this country, the focus groups were structured to include a mix of ages, education, countries of origin, and experience with the use of menopausal hormone therapy products.
A detailed review of these test results by the Menopause and Hormones working group will follow in March. Modifications to the campaign materials that will ensure that the final product is culturally appropriate, understandable and most useful to American women will be discussed. Revised materials will be available in Spring 2004.
The FY04 appropriations bill recently approved by Congress provided $500,000 for the FDA OWH to carry out important women's health outreach activities, including the Menopause and Hormone Information Campaign.
Next steps will include further strategies for distribution and dissemination of these materials by FDA and partners, and the identification of unique ways to utilize media (television, radio and print advertising) and the Internet to complement established outreach activities. We invite you to order these materials and distribute them in your newsletters, at meetings or by direct mail.
NEW Series of Educational One-Page Fact Sheets
The FDA Office of Women's Health is pleased to offer a new series of educational one-page fact sheets on a range of vital health topics that merit every woman's attention, including: Allergies, Stroke, Generic Drugs, Infertility, The Flu, and Asthma to name a few. These easy-to-read, fact sheets are available free of charge in printed and electronic (PDF) format. Take this opportunity to partner with us by making our new fact sheets available to your members. For more information about ordering materials or downloading, contact: FDA/Office of Women's Health, 5600 Fishers Lane HF-8, Rockville, MD 20857, 301-827-0350 Phone, 301-827-0926 Fax.
Approvals, Recalls, Etc
Consumers Advised to Stop Using Ephedra Immediately
On Dec. 30, 2003, FDA issued a consumer alert on the safety of dietary supplements containing ephedra. The alert advised consumers to immediately stop buying and using ephedra products. The FDA issued a final rule on February 6, 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra) because they present an unreasonable risk of illness and injury. The rule will become effective in 60 days.
Counterfeit Contraceptive Patch
The FDA and Johnson and Johnson Co. are warning the public about an overseas Internet site (www.rxpharmacy.ws) selling counterfeit contraceptive patches that contain no active ingredients. These counterfeit patches provide no protection against pregnancy.
Women who have been sent contraceptive patches lacking proper labeling or not have the appearance of the approved J & J Ortho Evra product should not use the product and should contact their healthcare providers immediately.
FDA Approves New Product for Facial Wrinkles
Studies conducted by the manufacturer showed that the device, Restylane™ Injectable Gel is safe and effective for filling moderate to severe wrinkles around the nose and mouth. Restylane is made with hyaluronic acid. Side effects of Restylane™ include: bruising, redness, swelling, pain, tenderness, and itching
The Reproductive Drugs and OTC Advisory committees met on December 16, 2003 to consider the safety and efficacy of new drug application proposing over-the-counter use of Plan B (levonorgestrel). The Advisory Committee's recommendation, represented by a vote of 23 to 4 was in favor of Plan B. If approved, Plan B would be sold in single use packages that would deter it from being used as a routine form of birth control. The final decision is expected to be made in February 2004.
Advisory Committee Meetings
Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee
February 26-27, 2004, Gaithersburg, MD.
Conferences and Meetings
Sister-to-Sister Everyone Has a Heart ® Health Fair: February 20th, 2004 -- Washington DC.
2004 National Women's Health Week: May 9-15, 2004
International Conference on Women and Infectious Diseases:
February 27-28, 2004 -- Atlanta, Georgia.
CDC "18th National Conference on Chronic Disease Prevention and Control": February 18-20, 2004 -- Washington, DC
"The 2nd World Congress on Women's Mental Health": March 17- - 20, 2004-Washington, DC.
National Hispanic Medical Association: March 19-21, 2004 --Washington, DC
9th Biennial Symposium on Minorities, Medically Underserved, & Cancer: March 24-28, 2004 -- Washington, DC
2004 Joint Conference of the American Society on Aging and National. Council on Aging: April 14-17, 2004 -- San Francisco, CA
ASTDHPPHE/CDC National Conference on Health Education and Health Promotion: May 5-7, 2004 -- Orlando, FL
National Rural Minority Health Conference: May 25-29, 2004 -- San Diego, CA
* In an effort to encourage you to schedule your routine screening health annual exams, the College of American Pathologists will send you email reminders for blood donation as well as tests for cholesterol, diabetes, colon cancer, pelvic exams and mammograms. All you have to do is sign up for the service (in English or Spanish) and when the reminder comes, be sure to schedule the appointment! For more information: www.MyHealthTestReminder.com
Other Health Information
Now Available in English, Spanish and Chinese!
"A LIFETIME OF GOOD HEALTH, YOUR GUIDE TO STAYING HEALTHY" -- THE PREVENTION GUIDE: This attractive, easy-to-read guide offers basic information that every woman needs to know to protect her health and the health of the ones she loves. You can order your copy now by calling NWHIC at 1-800-994-9662 or download it from their Web site.
Cooking Healthy is Easy -- Start Eating Right Today!
"Keep the Beat: Heart Healthy Recipes," contains recipes that can help towards maintaining a healthy diet. Download the booklet free of charge. Printed copies are available for $4.00 through the website or from the NIH NHLBI Information Center at P.O. Box 30105, Bethesda, MD 20824-0105, or at 301-592-8573 or 240-629-3255 (TTY).
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