Director's Message
Susan F. Wood, Ph.D.
The FDA Office of Women's Health continues to work on a wide
variety of priority women's health issues, ranging from diabetes,
mammography and safe medication use to inclusion of women in
clinical studies, medications used during pregnancy and regulatory
research. As we look to the future, the FDA OWH will focus new
efforts on women and cardiovascular disease, tackling the number
one killer of women from a wide range of approaches: research,
data analysis, policy and outreach. In this broad priority area,
there are numerous instances of sex and gender differences,
a clear need for better data and data analysis and connections
with other major public health concerns such as fitness, obesity,
smoking and diabetes. Products regulated by FDA are important
in the prevention and treatment of CVD, and we plan to be funding
new initiatives and maintaining current ones over the next several
years that will address this critical topic.
Other news in this issue of the OWH Update take note of several
awards won by OWH staff and our partners in the community. It's
great to see that our work is recognized! We've also launched
a new Fitness Challenge within FDA, and I'm inspired by the
number of FDA employees who have taken up the challenge!
Finally, FDA has also been in the news regarding the decision
to not yet allow the emergency contraception product Plan B
to go over the counter as a non-prescription product. We have
heard from thousands of women's health advocates and health
professionals calling for this product to be allowed to go over
the counter and we acknowledge the concerns that have been raised.
FDA, in issuing the non-approvable letter, laid out a pathway
for approval for the sponsor that leaves open the potential
for approval in the future. Your input and feedback is always
welcome on this and other important women's health issues that
fall within FDA's purview.
Consumer Alert -- Domperidone
The FDA is warning women against using the unapproved drug,
domperidone. Some women are using domperidone to increase milk
production for breastfeeding. Domperidone is not approved for
use in the United States.
Products containing domperidone have been found to cause serious
adverse affects including cardiac arrest, cardiac arrhythmias,
and sudden death in women in other countries. The impact of
domperidone on infant's health has not been determined.
Office of Women's Health launches a Fitness Challenge to encourage
FDA Staff to "Step Right Up" to Exercise
The latest research from the U.S. Centers for Disease Control
and Prevention (CDC) has revealed that obesity, resulting from
poor diet and sedentary lifestyles, will soon become the leading
cause of preventable death in the United States. In fact, CDC
estimates that 64 percent of all Americans are overweight, including
more than 30 percent who are considered obese.
In response to these recent findings, and in alignment with
FDA's own Obesity Initiative, the Office of Women's Health (OWH)
launched a 100-Day Fitness Challenge on May 10, 2004 to encourage
thousands of FDA employees to take action to fight obesity and
improve their health. The program is modeled after the President's
Challenge (www.presidentschallenge.org) and utilizes pedometers
to track daily steps. Program participants can take part either
on an individual or team basis to achieve chosen daily walking
goals of 4,000 or 10,000 steps. The overarching objective is
to help FDA staff make physical activity part of their day and
build habits to improve the likelihood of them remaining active
well after the conclusion of the competition.An interactive
website is used to record steps on a daily step log, track personal/team
progress, or compare it with others who have registered as part
of the OWH Fitness Challenge. At the conclusion, prizes will
be awarded to the most outstanding participants/team, or those
who have demonstrated the most improvement over baseline.
To date, there are more than 1800 FDA employees taking part
in the program. The Challenge will run from May 30 - September
6, 2004. We are very proud and excited by the response to this
initiative and look forward to a very active summer. Clearly
FDA is ready to Step Right Up! Happy walking everyone!!!
Take Time to Care Campaign -- More Cities Reaching Out
The Office is in the process of establishing an ongoing relationship
with the Conference of Mayors to focus on the dissemination
of FDA information regarding chronic illness.Our first venture
will be to mail copies our FDA/OWH Pink Ribbon Sunday Guides
to their membership of 1,600 mayors across the Nation.We will
jointly encourage them to education women about the importance
of mammography screening because early detection saves lives.
The final city to partner with us on Take Time To Care About
Diabetes is Las Vegas.They have done an exceptional job by forming
a Las Vegas TTTC Coalition that has planned activities throughout
the year.The lead organization In Las Vegas is Caesar's Entertainment
which operates six large hotel/casinos.They are a major employer
and are working with a number of other local organizations including
the Mayor's Office, Health Department, Parks Service, Culinary
Union, and many other hotel/casinos. The Mayor is the Honorary
Chair of the planning committee. He held a press conference
on April 8th to launch their activities.They have also ordered
thousands of TTTC brochures and recipe cards in both English
and Spanish for their events. In addition, local clinics and
wellness centers have our materials on display.NACDS assisted
them in securing assistance from Rite Aid to conduct assessments
in their local drug stores.
In order to target the Hispanic community, a high-risk population,
they worked with the local Parks Service to host an "Everybody
Dance" event. Families were encouraged to participate and
free food was provided for all.
Menopausal Hormone Therapy (MHT)
On May, 7 2004, the Menopause and Hormones working group was
honored with the Commissioner's Special Citation award for their
outstanding teamwork and exceptional cooperation that resulted
in the creation of a fact sheet, purse guide, and draft public
service announcement concerning the appropriate use of hormone
therapy for management of menopausal symptoms.
This year we will have distributed approximately 650,000 pieces
of information in both English and Spanish throughout the country.In
addition, FDA Public Affairs Specialists will do targeted educational
activities in San Juan, U.S. Virgin Islands, New York, Houston,
Atlanta, Dallas, Philadelphia, Buffalo, Los Angeles, Indianapolis,
in rural counties of New Jersey. These materials were developed
over an accelerated six-month time period for use in the Menopause
and Hormones communications outreach campaign launch on September
9, 2003. All materials utilized a clear, easy-to-understand
format and contained labeling based information summarizing
the benefits, risks and uncertainties associated with the use
of menopausal hormone therapy (MHT) products. These documents
served to clarify some of the uncertainty surrounding MHT and
to help ensure that women seeking treatment are informed participants
when making the decision with their health care professional
as to whether this therapy is right for them.
During mid-May, a contractor was identified to facilitate the
development and implementation of a nationwide communications
plan to disseminate the above Menopause and Hormones materials
to target audiences (English and Spanish speaking peri-menopausal
and menopausal) women and then track the effectiveness of those
efforts. In the coming weeks we will begin the process of working
with the contractor to ensure that essential project goals are
addressed in the development of the communications plan approach.
Awards
Congratulations to Marsha Henderson for being named a finalist
for the 2004 Service to America Career Achievement Medal.
Congratulations to our other award recipients! The Office of
Women's Health, FDA, DHHS and outside partners staff are
recognized for the following awards:
2004 FDA Science Forum Sigma Xi and Clear Science Communications
Outstanding Poster Award -- "Study Pregnant Women?
Yes, You Can!"
Office of the Commissioner Award of Excellence -- Report
to Congress: Demographic Information and Data Repository (DIDR).
Office of the Commissioner Special Recognition Award
-- Innovation and Excellence in the Creation of a
new Consumer Information Series of Fact Sheets
about FDA Regulated Products for Women and their Families.
Commissioner's Special Citation Menopause and Hormones Campaign
Working Group -- For outstanding performance and commitment
in review of significant Food and Drug Administration regulations.
Office of Women's Health
FY 2004 Science Program Awardees
Congratulations to the new and continuing research projects
that received the FY 2004 OWH Science Program Awards.
New Projects
Andrew Dayton -- CBER
Gender Dimorphism in HIV Infection in Primary Macrophages and
T-Lymphocytes: Kinetics of HIV Replication and efficacy of anti-retroviral
agents
Felice D'Agnillo -- CBER
Gender based differences in the vascular response to anthrax
toxin: investigation of the role of hormones in an in vitro
human endothelial cell culture system
Karen Lechter -- CDER
Gender Differences in the willingness to read and follow patient
information
Jove Graham -- CDRH
Development of guidelines for evaluating the appropriateness
of vertebroplasty surgery for patients for osteoporosis
Dennis Hinton -- CFSAN
Do phytoestrogens modify the allergic response to food allergens
in the newly validated, highly sensitive, in-bred asthmatic
rat model?
Continuing Projects
Eugene Herman -- CDER
Discovery and evaluation of interspecies biomarkers to monitor
the early onset and the progression of cardiovascular toxicity
associated with Thiazolidinedione compounds used in the treatment
of Type 2 Diabetes
Melvin Stratmeyer -- CDRH
Cardiovascular effects of ultrasound contrast agents in intact
and ovariectomized female animals
Robert Sprando -- CFSAN
Developmental Toxicity of Androstenedione in rates
Approvals
June 8, 2004: FDA approves Menostar, a low-dose estrogen
patch for use in the prevention of osteoporosis in postmenopausal
women.
June 1, 2004: FDA approves first-time generic Metronidazole
Topical Cream, 0.75% for the treatment of inflammatory papules
and pustules of rosacea. The innovator is MetroCream. |
