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Director's Message
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
Medical Officer
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.
Draft Guidances
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.
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 P, 301-827-0926 F.
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.
Emergency Contraception
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.
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