Welcome to the West Wing
Week, your guide to everything that's
happening at 1600 Pennsylvania Ave. This
week, the President nominated a bipartisan
slate of leaders to key administration jobs,
and the Vice President met with a wide array
of organizations to talk about efforts to
reduce gun violence.
Two of my highest priorities as
FDA commissioner have been strengthening the scientific
foundation of FDA’s regulatory decisions and ensuring the
safety of an increasingly complex and global food supply.
That’s
why I take such pride in FDA’s proposal of two rules that
set science-based standards for the prevention of foodborne
illnesses. One will govern facilities that produce food, and
the other concerns the safety of produce.
The
Preventive Controls for Human Food rule
proposes that
food companies—whether they manufacture, process, pack or
store food— put in place controls to minimize and reduce the
risk of contamination. The
Produce Safety rule proposes that farms that grow,
harvest, pack or hold fruits and vegetables follow standards
aimed at preventing their contamination.
These rules represent the very heart of the
prevention-based reforms envisioned by the landmark
FDA Food Safety Modernization Act (FSMA)
and focus on
preventing food safety problems before they happen.
These two rules are also part of a larger, ongoing reform
effort, with other rules that set similarly high standards
for imported and animal foods to be released in the near
future.
In our interconnected world, FDA’s vigilance must extend
globally. About 15 percent of our food is imported, and in
some categories that percentage is much higher. For example,
half of our fruits and a fifth of our vegetables come from
abroad. We need a strategy that will address all of these
complexities and challenges.
In drafting the proposed rules, FDA conducted extensive
outreach and talked with key stakeholders, including
farmers, consumer groups, state and local officials, and the
research community. They build on existing voluntary
industry guidelines and best practices for food safety,
which many producers currently follow.
We want to continue to engage the public. So, I encourage
Americans to review and comment on these rules, which are
available for
public
comment for 120 days.
I believe this also showcases FDA’s adherence to solid
science in its policy- and decision-making. The new draft
rules recognize that the science of food safety is
constantly evolving and that our oversight must take into
account issues such as emerging disease-causing bacteria and
new understandings of how hazards can be introduced into
food processing.
FDA is committed to working with industry to provide the
support they need, especially the smallest businesses.
That’s why we are working with stakeholders through the
Produce Safety Alliance, the
Sprouts
Safety Alliance, and the
Preventive
Controls Alliance to continue outreach efforts and to
make educational and technical information readily available
to industry.
Meeting the public health demands of a global
marketplace. Bringing solid science to bear on our decision
making. And safeguarding the well-being of American families
with a prevention-focused food safety system. That’s FDA at
work in the 21st century.
Margaret Hamburg, M.D., is Commissioner of
the Food and Drug Administration
A simple checklist
may help women learn if they are at risk of ovarian cancer. Researchers
surveyed 1,200 women, ages 40 and older, at a primary care clinic. They
asked if they were experiencing certain symptoms on a frequent basis –
abdominal pain, pelvic pain, difficultly eating, bloating, or feeling
full quickly.
Full Title: Screening and Diagnosing Gestational
Diabetes Mellitus
November 2012
This review aims to identify the properties of
screening and diagnostic tests for gestational diabetes
mellitus (GDM), to evaluate the potential benefits and
harms of screening, to assess the effects of different
screening and diagnostic thresholds on outcomes for
mothers and their offspring, and to determine the
effects of treatment in modifying outcomes for women
diagnosed with GDM.
Background: There is uncertainty as
to the optimal approach for screening and diagnosis of
gestational diabetes mellitus (GDM). Based on systematic
reviews published in 2003 and 2008, the U.S. Preventive
Services Task Force concluded that there was
insufficient evidence upon which to make a
recommendation regarding routine screening of all
pregnant women.
Objectives:
Identify properties of screening tests for GDM.
Evaluate benefits and harms of screening for GDM.
Assess the effects of different screening and
diagnostic thresholds on outcomes for mothers and
their offspring.
Determine the benefits and harms of treatment
for a diagnosis of GDM.
Data Sources: We searched 15
electronic databases from 1995 to May 2012, including
MEDLINE® and Cochrane Central Register of Controlled
Trials (which contains the Cochrane Pregnancy and
Childbirth Group registry); gray literature; Web sites
of relevant organizations; trial registries; and
reference lists.
Methods: Two reviewers independently
conducted study selection and quality assessment. One
reviewer extracted data, and a second reviewer verified
the data. We included published randomized and
nonrandomized controlled trials and prospective and
retrospective cohort studies that compared any screening
or diagnostic test with any other screening or
diagnostic test; any screening with no screening; women
who met various thresholds for GDM with those who did
not meet various criteria, where women in both groups
did not receive treatment; any treatment for GDM with no
treatment. We conducted a descriptive analysis for all
studies and meta-analyses when appropriate. Key outcomes
included preeclampsia, maternal weight gain, birth
injury, shoulder dystocia, neonatal hypoglycemia,
macrosomia, and long-term metabolic outcomes for the
child and mother.
Results: The search identified
14,398 citations and included 97 studies (6 randomized
controlled trials, 63 prospective cohort studies, and 28
retrospective cohort studies).
Prevalence of GDM varied across studies and
diagnostic criteria: American Diabetes Association (75
g) 2 to 19 percent; Carpenter and Coustan 3.6 to 38
percent; National Diabetes Data Group 1.4 to 50 percent;
and World Health Organization 2 to 24.5 percent. Lack of
a gold standard for the diagnosis of GDM and little
evidence about the accuracy of screening strategies for
GDM remain problematic. The 50 g oral glucose challenge
test with a glucose threshold of 130 mg/dL versus 140
mg/dL improves sensitivity and reduces specificity. Both
thresholds have high negative predictive values (NPV)
but variable positive predictive values (PPVs) across a
range of prevalence. There was limited evidence for the
screening of GDM diagnosed less than 24 weeks' gestation
(three studies). One study compared the International
Association of Diabetes in Pregnancy Study Groups'
(IADPSG) diagnostic criteria with a two-step strategy.
Sensitivity was 82 percent, specificity was 94 percent.
Only two studies examined the effects on health
outcomes from screening for GDM. One retrospective
cohort study (n=1,000) showed more cesarean deliveries
in the screened group. A survey within a prospective
cohort study (n=93) found the same incidence of
macrosomia (≥4.3 kg) in screened and unscreened groups
(7 percent each group).
Thirty-eight studies examined health outcomes for
women who met different criteria for GDM and did not
undergo treatment. Methodologically strong studies
showed a continuous positive relationship between
increasing glucose levels and the incidence of primary
cesarean section and macrosomia. One of these studies
also found significantly fewer cases of preeclampsia,
cesarean section, shoulder dystocia and/or birth injury,
clinical neonatal hypoglycemia, and hyperbilirubinemia
for women without GDM compared with those meeting IADPSG
criteria. Among the other studies, fewer cases of
preeclampsia were observed for women with no GDM and
women who were false positive versus those meeting
Carpenter and Coustan criteria. For maternal weight
gain, few comparisons showed differences. For fetal
birth trauma, single studies showed no differences for
women with Carpenter and Coustan GDM and World Health
Organization impaired glucose tolerance versus women
without GDM. Women diagnosed based on National Diabetes
Data Group GDM had more fetal birth trauma compared with
women without GDM. Fewer cases of macrosomia were seen
in the group without GDM compared with Carpenter and
Coustan GDM, Carpenter and Coustan 1 abnormal oral
glucose tolerance test, National Diabetes Data Group GDM,
National Diabetes Data Group false positives, and World
Health Organization impaired glucose tolerance. Fewer
cases of neonatal hypoglycemia were found among patient
groups without GDM compared with those meeting Carpenter
and Coustan criteria. There was more childhood obesity
for Carpenter and Coustan GDM versus patient groups with
no GDM.
Eleven studies compared diet modification, glucose
monitoring, and insulin as needed with no treatment.
Moderate evidence showed fewer cases of preeclampsia in
the treated group. The evidence was insufficient for
maternal weight gain and birth injury. Moderate evidence
found less shoulder dystocia with treatment for GDM. Low
evidence showed no difference for neonatal hypoglycemia
between treated and untreated GDM. Moderate evidence
showed benefits of treatment for reduction of macrosomia
(>4,000 g). There was insufficient evidence for
long-term metabolic outcomes among offspring.
Five studies provided data on harms of treating GDM.
No difference was found for cesarean delivery, induction
of labor, small for gestational age, or admission to a
neonatal intensive care unit. There were significantly
more prenatal visits among those treated.
Conclusions: While evidence supports
a positive association with increasing plasma glucose on
a 75 g or 100 g oral glucose tolerance test and
macrosomia and primary cesarean section, clear
thresholds for increased risk were not found. The 50 g
oral glucose challenge test has high NPV but variable
PPV. Treatment of GDM results in less preeclampsia and
macrosomia. Current evidence does not show that
treatment of GDM has an effect on neonatal hypoglycemia
or future poor metabolic outcomes. There is little
evidence of short-term harm from treating GDM other than
an increased demand for services. Research is needed on
the long-term metabolic outcome for offspring as a
result of GDM and its treatment, and the "real world"
effects of GDM treatment on use of care.
Download Report
Screening and Diagnosing Gestational Diabetes
Mellitus
Evidence-based Practice Center:
University of Alberta
Current as of November 2012
Internet Citation:
Screening and Diagnosing
Gestational Diabetes Mellitus, Structured Abstract.
November 2012. Agency for Healthcare Research and
Quality, Rockville, MD. http://www.ahrq.gov/clinic/tp/gdmexuptp.htm
I’m a relative newcomer to government
work, joining FDA about 18 months ago after decades of being
a journalist. My job is to assign, write and edit FDA
Consumer Updates, news stories posted on fda.gov that are
designed to give consumers important information in language
that’s easy to understand. Not too technical or
bureaucratic.
To
endear myself to my new colleagues, I decided to write about
anything that we saw as boring, leaving them to write about
the hotter topics. I’m not easily bored, so I thought this
would work as a noble gesture.
Even with this resolve, my heart sank when I was asked to
write about regulatory science – one of FDA’s highest
priorities. Do you remember the character Chandler Bing from
the TV show “Friends”? I could hear his voice in my head:
“Could this BE more boring?”
But I resolutely set about my task and five Consumer
Updates later, I’m here to tell you that regulatory science
is NOT boring. Not even close.
The official definition: “Regulatory science is the
science of developing new tools, standards and approaches to
assess the safety, effectiveness, quality and performance of
FDA-regulated products.”
Ok. Put down the remote and give me a minute.
FDA has a huge impact on your daily life. Think about the
foods you eat, medicines you take, vaccines your kids are
given, the medical devices as commonplace as band-aids and
toothbrushes and as complicated as an artificial heart, the
foods and medicines you give your pets. FDA’s job is to make
sure that products like these, and many, many more, do what
they’re supposed to do —and do it safely.
Regulatory science is the proof that’s in the pudding, so
to speak. It’s how FDA collects the scientific evidence it
needs to determine if a regulated product will actually make
your life better. It’s how FDA collects the scientific
evidence it needs to ensure that the foods you eat at home
or in restaurants are safe to eat. (How they taste is not
our problem.)
Regulatory science identifies and tracks nasty bacteria
that contaminate food. It creates genetic tests to determine
if medication could work for you specifically—not just for
people who are like you in some way. It puts human cells on
a computer chip that mimic the function of organ systems,
thereby possibly reducing the need to test new drugs on
animals.
It’s the virtual family—a scary looking group of computer
models that scientists can use to see what medical devices
would work for their patients.
I especially liked meeting the scientists. Some of them
struck me as a bit eccentric, as you might expect. Others
are shy and reticent. What they have in common is a genuine
commitment to make the world a better place – a safer place.
So the next time that you read the words “regulatory
science,” take a second look. The work that goes on under
that banner could save your life someday.
Susan Kelly is the managing editor of
Consumer Health Information at FDA.
Drug shortages are two words that no
one wants to hear—not patients, not health care
professionals, and not me.
FDA
has been working hard to prevent and mitigate drug
shortages. In 2011, the number of medications in short
supply hit 251. Addressing drug shortages must be a top
priority for us at FDA because these are medications that
people need to stay healthy, to treat their illnesses, and
even, in some cases, to stay alive.
This year, we’ve taken significant
steps to expand our efforts and to engage in new ways with
industry. Between Jan. 1 and Sept. 30, 2012, FDA worked with
drug manufacturers to help avert the shortage of 145 drugs.
Many critical medicines used to treat cancer and conditions
such as attention deficit hyperactivity disorder (ADHD) are
no longer in short supply.
However, drug shortages are still a
serious problem, one that may be temporarily impacted by
Ameridose LLC’s voluntary recall of all of its unexpired
products. Ameridose, located in Westborough, Mass., is
managed by some of the same people as the New England
Compounding Center—which produced the drug that is
implicated in the deadly, multi-state outbreak of fungal
meningitis. An inspection of Ameridose was initiated as part
of FDA’s ongoing investigation of the outbreak.
FDA recommended that Ameridose
recall its sterile drugs because we could not be assured of
the sterility of those products. However, this recall may
affect supplies of certain life-saving drugs for some health
care systems. FDA has identified a number of Ameridose
products—including drugs used during surgery and to treat
medical conditions that include congestive heart
failure—that were on the current drug shortages list before
the recall.
We also know that the supply of
other drugs may be affected by the Ameridose recall. That’s
why FDA is taking proactive steps to minimize the impact
this recall may have on current drug shortages, and to
prevent other shortages from occurring.
For recalled medications on the
current drug shortages list, FDA is taking the same actions
it has used successfully to mitigate other shortages.
FDA is working with
manufacturers of these drugs, requesting that they ramp
up production if they are willing and able to do so.
For any manufacturers of these
drugs that may be experiencing manufacturing or quality
problems, FDA is offering assistance to enable them to
produce shortage drug products that are safe and high
quality.
As with shortages of any
critical products, FDA will expedite the reviews of any
pending applications that could help with addressing the
shortages.
FDA is identifying any
additional manufacturers willing to initiate or increase
production.
If manufacturers of critical
drugs are not able to meet U.S. patient needs, FDA will
explore overseas companies that are willing and able to
import foreign drugs to address the shortage. In these
instances, FDA evaluates the imported drug to ensure
that it is of adequate quality and that the drug does
not pose undue risks for U.S. patients.
Since the beginning of the year,
the number of advance notifications to FDA of potential
shortages has greatly increased. If we know that a problem
is on the horizon, we’re able to proactively work with
industry, organizations, patients and stakeholders to
address it. We have doubled the number of staff members who
work in drug shortage prevention and response.
We at FDA are committed to doing
everything we can, using all available tools, to prevent or
mitigate drug shortages and help keep critically needed
products on the market.
Margaret A. Hamburg,
M.D., is Commissioner of the U.S. Food and Drug
Administration.
You may think that FDA is simply an
organization that reviews medical products or works to keep
your food safe. But FDA’s broad public health mission
includes mobilizing to protect Americans when natural
disasters like Hurricane Sandy strike.
FDA
Commissioner Margaret A. Hamburg visits the
Emergency Operations Center at the agency’s
headquarters in Silver Spring, Md., where FDA
experts are monitoring, assessing, and responding to
the impact of Hurricane Sandy on FDA regulated
facilities and products. Mark Russo, acting director
of FDA’s Office of Crisis Management, and other
members of the FDA Incident Management Group brief
the commissioner on their progress. Click on the
photo to enlarge it.
We often think of major storms
like Sandy in terms of the risk to life and damage to
property. But at FDA we also have to focus on the
effects of natural disasters on the safety of the
products we regulate and that consumers and patients
depend on – everything from fresh produce to canned
foods to medicines and high-tech medical
devices. Flooding, extreme temperatures, and power
outages can create a multitude of safety problems for
those products and the facilities where they are made
and stored.
FDA’s preparation for hurricanes
begins even before the tropical season starts. Every year,
we use our Geographic Information System to create and
continuously update a set of maps and a list of
FDA-regulated facilities, sorted by the type of product the
facilities produce. This information prepares FDA offices
across the country to act immediately in the event of a
natural disaster by showing us the location of the affected
facilities.
FDA’s work during public health
emergencies is coordinated through our Emergency Operations
Center, which is in a constant state of readiness 24/7. The
EOC, as we call it, is staffed by FDA experts on such
subjects as emergency management and coordination,
investigation, epidemiology, public and environmental
health, the safety of food and medical products, imported
products, legal issues, and cartography.
To prepare for Hurricane Sandy, we
consulted with other public health and preparedness
agencies, received regular updates from the National
Hurricane Center, and conferred with sister agencies during
telephone conferences conducted by the Federal Emergency
Management Agency (FEMA). And to help the public prepare, we
posted information on our website about ensuring the safety
of food and medical supplies.
This map in FDA’s Emergency Operations Center shows
the concentration of FDA-regulated facilities in
each affected county. Combined with an overlay of
the projected rainfall amounts provided by the
National Weather Service, the FDA is able to tell at
a glance which facilities producing FDA-regulated
products would be impacted by Hurricane Sandy. Click
on the map to enlarge it.
As Sandy moved up the East
Coast, the experts in our EOC swung into action. We
created a series of maps for FDA field offices overlaid
with the predicted storm track and FDA-regulated
companies in the storm’s path to give us a picture of
Sandy’s potential impact. Monitoring reports from our
field offices, we produced situation reports, which we
fed to FEMA and other agencies. This awareness was
crucial in strengthening the agencies’ preparedness and
immediate response efforts.
In the wake of Hurricane Sandy,
some of our most important work is just beginning. FDA’s
district offices are reaching out to the affected states and
regulated industries to assess the full impact of this
devastating storm. Our offices are using detailed and
specialized maps, as well as historical information about
facilities, to decide which manufacturing plants to inspect
first.
The first priority might be a
damaged plant that manufactures complex monoclonal
antibodies to treat cancer, a flooded facility that produces
medical devices, or a cold storage food warehouse that has
lost power. As we assess the damage, we need to inspect
facilities and focus on situations that pose the greatest
risk to public health and safety.
The
Emergency Operations Center is staffed during a
disaster like Hurricane Sandy by a FDA Incident
Management Group comprised of personnel who are
expert in a variety of public health and regulatory
areas. They work with FDA Incident Management Teams
in the field to monitor the impact of the storm and
help shape the agency’s response. Click on the photo
to enlarge it.
In the case of an unprecedented
natural disaster like Sandy, state and local governments
may ask for help with tasks they normally perform, such
as inspecting restaurants, school and hospital
cafeterias, and facilities where diagnostic x-ray and
mammography equipment are installed. Working with our
parent Department of Health and Human Services and FEMA,
FDA can provide expert teams of inspectors with
specialized training to assess and help correct
problems.
Fortunately, storms like Sandy
occur rarely. But when they do, FDA employees are on the
job, dedicated to protecting the public health and working
to keep you safe.
Margaret Hamburg, M.D.,
is Commissioner of the U. S. Food and Drug Administration
The growth in drug development has
begun to bear fruit, particularly for the treatment of
breast cancer. As Commissioner Hamburg pointed out in her
blog earlier this month, 40 percent of all drug development
is in cancer research, and a significant part of that work
is focused on breast cancer. And we’ve learned a lot about
breast cancer in the last decade, including that one therapy
does not treat all. Despite many advances in treatment, the
need for new and effective therapies remains.
Accelerating
development of effective new drugs for breast cancer
patients has been a top FDA priority for some time. In
recent months, FDA has been examining the use of novel
anti-cancer therapies prior to surgery. This is known as
neoadjuvant therapy, which we believe has the potential
to advance drug therapy for breast cancer even further,
including the possibility of converting an inoperable breast
cancer tumor into an operable one. Preoperative therapy
could also make it possible to identify—early in
treatment—tumors that are resistant to chemotherapy,
enabling doctors to discontinue ineffective therapy and
better assess the likely course and outcome of the disease.
We’ve come a long way… but
there is still a ways to go
To continue to develop these new
preoperative therapies, we need new and innovative ways to
test their effectiveness and safety. To evaluate this
innovative approach, a new endpoint is needed — an
outcome from a clinical trial that FDA will accept as
evidence that the drug will be effective. This means some
new ways of thinking about what kind of information from
clinical studies constitutes enough evidence to consider a
drug both safe and effective.
FDA has shared its thoughts and
views with the pharmaceutical industry on this subject via a
document called a
draft guidance, which discusses
endpoints for clinical trials that may be considered when
studying new drugs intended for neoadjuvant therapy.
In the years ahead, patients may
have access to entirely new classes of drugs specifically
designed to treat their breast cancer while sparing them
some of the often harsh side effects of traditional
anti-cancer therapies. For our part, we are continuing to
learn all we can about the newest therapies being developed.
We are also working with both academic researchers and drug
makers on innovative clinical trial designs so that safe and
effective drugs can reach the public as soon as possible.
Robert Justice, M.D.,
M.S., is the director of the Division of Oncology Products 1
in the Office of Hematology and Oncology Products in FDA’s
Center for Drug Evaluation and Research
I have been with FDA for more than 20
years and an oncologist for 30 years. During this time, I
have witnessed an evolving change in our understanding of
cancer. We once viewed cancer as a single disease, such as
breast or lung cancer. Today we understand that most cancers
that arise in a single organ or area of the body are often a
genetically diverse group of cancers that have different
patterns of spread, different rates of growth, and different
responsiveness to treatment.
To
understand the progress we’ve made today in breast cancer,
one has to look back at how changes in treatment
expectations among oncologists, emerging scientific
discoveries, and greater influence and advocacy from
patients all fundamentally changed the nature of cancer drug
reviews at FDA.
The late 1980s and early 1990s
represented a dramatic shift in how oncologists began
thinking about what treatments could achieve. Before this
time, the effectiveness of a treatment was often measured by
its ability to shrink a tumor, rather than its ability to
extend a patient’s life or prevent the cancer from
spreading, which is a common expectation of treatment today.
In addition, effective drug treatment was often limited to
extremely toxic chemotherapies that generally killed healthy
cells and cancer cells indiscriminately, further
compromising the quality of life for patients with cancer.
During this time, independent
cancer experts tapped by FDA recommended that the oncology
community expect more from cancer treatments. They advised
FDA to approve a greater number of effective drugs,
including approvals based on a single study of efficacy—with
the understanding that, in some cases, the risks of the new
treatments may not be fully known at approval because fewer
total patients had been studied. This new way of thinking
about cancer care has had a profound effect on FDA’s
approach to guiding the clinical development of new cancer
treatments.
Arguably, no type of cancer
treatment has benefited from this shift in thinking more
than breast cancer. Before 1990, there were few effective
drugs for patients who developed metastatic disease, in
which the cancer has spread to other parts of the body.
However, the last decade of the 20th century saw
the approval of several new drugs and drug classes. One new
drug in particular, Herceptin (trastuzumab), would change
the landscape of breast cancer treatment and transform the
outcome of a particularly deadly type of the disease for
some patients.
Herceptin was approved in 1998 for
a specific type of breast cancer known as HER2-positive
metastatic breast cancer. It was just the second cancer drug
approval for a new category of drugs called monoclonal
antibodies and helped usher in the era of personalized
medicine in cancer treatment in which a patient’s tumor
cells are assessed to determine if a particular drug could
be an effective treatment. Herceptin’s complex molecules are
manufactured through biotechnology and work by binding to
the surface of cancer cells, where they prevent substances
in the blood from stimulating tumors to grow and make it
easier for the patient’s immune system to attack and kill
the cancer cell. While monoclonal antibodies, their
production methods, and the identification of patients who
might obtain the best results are much better understood
today, there was very little experience to draw from in the
mid-1990s.
Herceptin forced my fellow
reviewers and me to adapt quickly to a number of unexpected
findings during the clinical investigations and review of
the study results, including the limitations of animal
studies in predicting risks for patients. We had operated
under the assumption that Herceptin would have side effects
that were more like hormone therapies not considered to be
toxic. In reality, we learned that Herceptin had unique side
effects (i.e., damage to heart muscle) that patients had to
be informed of during their participation in these clinical
studies.
It was during this time we learned,
and better understood, how the amount of HER2 protein on the
surface of cancer cells could predict which patients would
or would not likely benefit from treatment. We also became
aware of the necessity of approving a reliable companion
diagnostic test to identify patients most likely to benefit
from the treatment, concurrent with approving the drug.
After more than a decade of
experience with the use of diagnostic tools to direct
patient management, physicians can give these targeted drugs
to patients whom they know have the genetic makeup that will
enable the drug to be effective.
Cancer advocacy has advanced
tremendously as well during the last two decades of the 20th
century. I distinctly remember that FDA had to balance the
excitement prompted by therapies then under development with
the reality that some women living with breast cancer
wouldn’t survive long enough to benefit from them, and the
need to encourage pharmaceutical companies to provide
patients with access to investigational drugs during the
drug review process. It was during this time that, through
the efforts of FDA’s Office of Special Health Issues and
especially the efforts of Patricia Delaney from that office,
my colleagues and I became well-acquainted with a
highly-organized and well-educated group of advocates, both
men and women, who fought tirelessly to get patients access
to drugs that are still being studied. They left an
indelible impression on each of us.
Today, progress continues.
Pharmaceutical companies, the medical oncology community,
and FDA have worked together on development of new drug
classes, better drug screening, and innovative research to
rapidly identify potentially effective new treatments. These
efforts have helped save the lives of many women world-wide.
While we still have far to go, the pace of change has been
rapid and the future of breast cancer drug development looks
much brighter!
Patricia Keegan, M.D.,
is the director of the Division of Oncology Products 2 in
the Office of Hematology and Oncology Products in FDA’s
Center for Drug Evaluation and Research
When there is a multi-state outbreak
of illnesses, what federal agencies are doing in response is
often the focus of attention. All too often, the dedicated
efforts of countless other public servants at the state,
county, and local levels aren’t acknowledged as much.
As
we all strive to resolve the tragic outbreak of fungal
meningitis tied to contaminated steroid injections, I want
to recognize the invaluable role of our colleagues across
the country. These frontline public health officials at all
levels of government work alongside the Food and Drug
Administration (FDA) and the Centers for Disease Control and
Prevention (CDC) every day, and even more closely in times
of crises.
State, county, and local health
officials are often the first to hear about a problem and
begin investigating. In this deadly outbreak of fungal
meningitis, the alarm was first sounded by the Tennessee
Department of Health. Tennessee has been one of the hardest
hit in this outbreak. The Tennessee health department was
told by a clinician on Sept. 18, 2012, about a patient with
culture-confirmed Aspergillus meningitis
By Sept. 27, Tennessee public
health officials, in collaboration with the CDC and the
North Carolina Department of Health and Human Services, had
identified eight additional patients with similar meningitis
symptoms, but lab results were not showing a clear
cause. With persistence, shoe-leather epidemiology and
amazing laboratory efforts, state and federal public health
officials worked quickly to narrow down the common exposure
of these patients. They ultimately identified a steroid
solution compounded at the New England Compounding Center
(NECC) in Framingham, Mass., as the likely source of the
outbreak. Conclusive evidence of fungal contamination was
confirmed on Oct. 3, when FDA identified fungus in sealed
NECC vials. CDC and state laboratories later pinpointed the
fungus, Exserohilumrostratum, in both
patients and also in unopened vials of the steroid
solution.
The FDA has been working closely
with the CDC and public health officials in Massachusetts
and other states to investigate the scope and cause of the
outbreak. In fact, both agencies have been working
hand-in-hand with our colleagues in every state affected by
this outbreak.
The demanding task of tracking down
the thousands of people who were potentially exposed to
medications from one of three implicated lots of
contaminated NECC medication has involved state, county and
local health officials, the CDC and health care providers.
So far almost all—97 percent—of the patients exposed to the
original three implicated lots have been contacted. Now, FDA
is urging healthcare providers to follow-up with patients
who were administered any NECC injectable product that was
shipped on or after May 21, 2012, including
an ophthalmic drug that is injectable or used in conjunction
with eye surgery, or a cardioplegic solution purchased from
or produced by NECC.
More legwork is being performed by
local, county and federal epidemiologists who are
interviewing patients to collect key data about their
experience while state public health officials are pitching
in to help FDA ensure that the recall of NECC products is
carried out in a timely and effective way, with no NECC
products remaining in distribution.
Nearly every day our counterparts
in the states play a role in helping the FDA fulfill its
mission of keeping Americans safe and healthy. We work
together, across state lines and levels of government,
whether the issue is foodborne illness, drug safety or other
concerns. Frankly, we are immensely grateful for their
expertise, professionalism and commitment to the people of
their states and beyond.
In the face of this current
tragedy, we are all working hard—together—to fully contain
the health risks associated with this outbreak as quickly as
possible to protect patients and the nation’s medical drug
supply.
Margaret A. Hamburg,
M.D., is the commissioner of the Food and Drug
Administration.
Clarification, November 5, 2012:
CFAST is a joint initiative of CDISC and the Critical Path
Institute. The FDA and TransCelerate Biopharma, Inc. are
partnering with CFAST in its
Therapeutic Area Standards Program.
A new partnership between the FDA,
the
Clinical Data Interchange Standards Consortium (CDISC),
and the
Critical Path Institute (C-Path)
was officially launched today at the CDISC International
Interchange in Baltimore. This partnership, called the
Coalition For Accelerating Standards and Therapies or CFAST,
will bring together clinical data experts from the FDA, the
pharmaceutical industry, and the information technology
sector, to develop and maintain data standards tailored to
individual diseases and therapeutic areas.
While
I was preparing my keynote address for the Interchange, I
began thinking of how history provides us lessons for the
future, and the Great Baltimore Fire of 1904 is a particular
example that stands out in my mind. In this tragedy,
thousands of firefighters from surrounding cities and states
responded to Baltimore’s call for help, but they were unable
to assist in putting out the fire because their hoses and
equipment were not compatible with the Baltimore hydrant
connections. This terrible event made the need for
standardized fire-fighting equipment and connections
devastatingly clear.
As part of the changing tide of
drug regulation, we are seeing ever-increasing streams of
data coming into the agency. However, much like standardized
fire-fighting equipment, we need to develop standardized
definitions for individual diseases and the therapeutic
approaches to treat them to be able to tap into this data
stream.
Standardized data elements that are
common to all clinical trials, such as age and gender, have
been established using CDISC terminology. However, data
elements that are unique for a particular disease or
therapeutic area still need to be developed so that the data
from multiple trials can be more easily grouped for
reporting and analysis.
In short, establishing common
standards for data reporting will provide new opportunities
to transform the massive amount of data from drug studies on
specific diseases into useful information to potentially
speed the delivery of new therapies to patients.
We at the FDA are excited to be a
member of this very important partnership. We believe that
CFAST will provide an important resource for drug
development and research that will result in enhancements in
the evaluation of safe and innovative therapies for the
public.
By: Marsha B. Henderson,
M.R.C.P. and Helen Barr, M.D.
Like millions of women, we go each
year to get a mammogram. For us the experience is not
just about healthy living. It is also a reminder of the
value of our hard work at FDA. Each time we see the FDA
certificate in our mammography facility showing that the
facility meets FDA’s high standards, we are reminded of
the commitment and dedication of FDA employees to
supporting mammography services.
Marsha B. Henderson, M.R.C.P. (left) and Helen Barr,
M.D.
Under the
Mammography Quality Standards Act and Program,
FDA employees work to ensure that women can go anywhere
in the country and expect to get reliable, high quality
breast images. We certify and inspect mammography
facilities establishing uniform standards for
mammography equipment and staff training. Thanks to
these efforts, there are over
8,600 certified mammography facilities
in rural and urban communities across the country.
We didn’t stop there. Early on, we
realized that regulation was only part of what was needed.
FDA recognized that it should also help raise awareness
about the importance of mammography. Through the
Pink Ribbon Sunday Program, we
formed outreach partnerships to teach women the facts about
mammography screening. When the Pink Ribbon Sunday Program
began in the 1990s, we targeted African American and Latino
women because they were least likely to get a mammogram.
However, the program quickly spread from minority churches
to businesses, sororities, health centers, and other
national organizations reaching women from all backgrounds.
Over the years, FDA has touched
millions of lives through our mammography initiatives. We
have chosen today – National Mammography Day – to thank our
colleagues at FDA and our partners in the health care
community and state and local governments for their
efforts. We also encourage you to help connect the women in
your community to
our free mammography resources.
Your efforts can help raise awareness, provide hope, and
maybe even save a life.
Marsha Henderson,
M.C.R.P., is FDA’s Assistant Commissioner for Women’s Health
in the Office of the Commissioner
Helen Barr, M.D., is
FDA’s Director of the Division of Mammography Quality
Standards at the Center for Devices and Radiological Health
It’s
October and the pink ribbons representing breast cancer
awareness month are again a common sighting. These ribbons
are reminders that breast cancer is still to be overcome.
Breast cancer remains the most common cancer among American
women, except for skin cancers. Just about everyone knows
someone affected by cancer in general, and many have been
touched by breast cancer in some way.
For many years, I worked at the
Government Accountability Office (GAO), where I became
familiar with FDA. I joined FDA’s
Office of Special Health Issues
(OSHI) in September 2008 because I wanted to be involved
more directly with patients again after working for years
during my earlier career with seriously ill patients and
their families as a neonatal nurse, research nurse, and
hospice volunteer.
Like a lot of people, I have
experience with cancer – personal, family members, and
friends. As the manager of OSHI’s Cancer Liaison Program,
I’ve had many experiences that have enhanced my compassion,
respect, and patience as I strive to explain FDA’s role in
medical product development and regulation to patients with
breast and other cancers.
FDA’s Cancer Liaison Program
interacts with many cancer patients and family members
asking for help. The program seeks to meet the needs of
patients and their families in three basic ways. Listening,
educating, and assisting.
First and foremost, we
listen to patients and caregivers. They tell
us their story – when they were diagnosed, treatments they
have tried, providers they have seen, and tests they have
been through. Often, they tell us they’re scared.
Some of these patients have been
dealing with cancer for a number of years, and they tell us
that the approved therapies have not worked or have stopped
working. Some have considered or joined a clinical trial of
an investigational therapy. Some call with the hope of
obtaining a “promising” new investigational product that
they have heard about in the news and are convinced may be
their last hope.
Secondly, we educate.
We spend a significant amount of time explaining to patients
and family members how cancer drug development, clinical
trials, and expanded access, (known in the community as
compassionate use) work. We explain FDA’s role, and what we
can and cannot do for patients, and try to guide patients
toward practical and appropriate options.
We help bridge the gap between
patients, their treating physicians, and FDA scientists who
are working to review and approve new treatment options for
patients. We strive to provide a human touch for each
patient or family member with whom we interact.
Finally, we assist
the patients. For example, we try to find potential clinical
trials for them, guide them through the
expanded access process when it’s
appropriate, and work with their healthcare providers
throughout the expanded access application process. We give
patients, family members, and healthcare providers our
contact information so they can reach us to work through
regulatory issues at any time, including evenings and
weekends. We periodically call them to see how they’re
doing.
And if access to investigational
drugs is not practical, we go back to listening. We listen
to patients’ expressions of their disappointment, anger,
frustration, and fears.
This month, I am thinking about the
many breast cancer patients I worked with during this past
year who benefited from FDA’s approval of Perjecta in June.
But I am equally mindful of the many other patients who did
not benefit from the drug and will be calling me,
desperately searching for something more.
Deborah Miller, Ph.D.,
M.P.H., R.N., is the manager of the Cancer Liaison Program
in FDA’s Office of Special Health Issues
The Drug Amendments of 1962, also
known as the Kefauver-Harris Drug Amendments, became law
five decades ago. But this law’s importance grows with each
passing year, making Americans safer than ever from unsafe
and ineffective medicines.
To
understand why this law stands today as a pillar of public
health in America, it helps to look at how our history
shaped it.
There was a system of drug controls
in place as early as 1905 that took effectiveness into
account, but it was voluntary and administered privately by
the American Medical Association. Congress passed laws that
required effectiveness from the early 1940s on, but only for
selected medicines, such as insulin and penicillin. In 1941,
FDA developed regulations to ensure good manufacturing
practices to ensure a product’s quality and purity, but only
for one drug category. Technically, the Federal Trade
Commission had been regulating drug advertising since 1938,
but there was little strength in its hold on this industry.
And the 1938 Food, Drug, and Cosmetic Act required evidence
of a drug’s safety, but the nature of that proof and
oversight over how it should be developed were not that
clear.
In 1959 Sen. Estes Kefauver began
hearings that focused on the high cost of
medicines—reflected in the comprehensive bill he introduced
in April 1961. But priorities shifted substantially in the
next year with the global thalidomide disaster, narrowly
averted here, in which a sedative used to treat morning
sickness caused thousands of birth defects around the world.
Substantial legislative input from FDA helped shape the law
that President Kennedy signed on October 10, 1962. And it
changed everything: requirements for therapeutic viability
of drugs, veracity in marketing, the proper conduct of
investigations, verifiable production controls, patient
protections, actual FDA assent to constitute approval, and
rigorous proof as the essential element of a drug
application.
FDA assembled clinical experts to
advise the Agency on drugs previously approved for safety
only. They reviewed the available evidence on the
effectiveness of those drugs and found that on average 4 out
of 10 drugs approved before 1962 and still
marketed—medicines that physicians prescribed to their sick
patients—either did not work or needed more—often much
more—evidence that they did. In the following years FDA
removed more than 1,000 of these from the market. At the
same time, the agency further called upon therapeutic
experts through the systematic use of advisory committees to
offer their insights into approval decisions, decisions that
still ultimately rested with FDA.
In sorting out this therapeutic
mess from the pre-1962 era, the investigational,
manufacturing, and regulatory communities reached an
understanding about what constituted acceptable evidence,
which generally meant randomized, well-controlled clinical
trials. While that definition shifted over the following
years to accommodate, for example, the needs of gravely ill
patients facing few if any treatment options, these changes
did not come at the expense of good clinical evidence.
Science remained the benchmark of Kefauver-Harris’s legacy.
So, the Drug Amendments of 1962
elevated medical practice, pharmaceutical manufacturing, and
public health by inserting a much greater degree of
certainty in the way drugs are tested, manufactured,
approved, advertised, prescribed, dispensed, and taken.
Hurricane Sandy caused untold destruction and
chaos up and down the east coast last week, and
as we now know, it was poised to hit New York
City and New Jersey with special ferocity.
But as the storm gathered strength in the
Atlantic last weekend, officials within the
New York
Harbor Health Care System and the Veterans
Integrated Service Network (VISN) 3 leadership
team made a crucial decision: get the patients
out of the Manhattan flood zone before the
storms reached the city. The VISN worked with
leadership on the ground to quickly and safely
coordinate the transfer of all patients and
staff to other hospitals in the network.
“The first priority in these situations is
always patient and employee safety,” said
Jennifer Sammartino, a public affairs officer
for the NY Harbor Healthcare system.
This isn’t the first time a VA hospital
director has been faced with a difficult
decision to evacuate patients before an
emergency situation. Hurricane Irene forced the
Manhattan facility to evacuate last year with no
issues, Sammartino said. The Hampton VA Medical
Center in Virginia also evacuated before the
storm, among other facilities.
VA social media continues to play a vital
role in getting accurate and timely news to
Veterans and employees affected by the chaotic
storm. Sammartino is continuing to update the
NY
Harbor Healthcare System Facebook page and
Twitter feed to keep Veterans and staff abreast
of developing conditions. The New Jersey Health
Care System has
also taken
to Twitter to alert Veterans on which
facilities are open or closed, allowing for
Veterans to pivot to other facilities.
Earlier today, VA’s New York Harbor
Healthcare System’s Manhattan facility announced
it would remain closed as damage assessment
continues. The Brooklyn VA Medical Center and
the St. Albans Community Living Center are open
and receiving patients. The New Jersey Health
Care System is also open with info about the
operations of clinics and local Community Based
Outpatient Clinics on their
website.
Veterans can call centralized scheduling at
1-877-877-9267 to schedule an
appointment at these and other facilities.
Here’s a list of telephone numbers for
Veterans to use for information on general
health questions, appointments, and for
medication refills:
For medical emergencies, please
dial 911.
Emergency prescription refills:
Go to a big chain drug store with your VA Id
card and prescription bottle and ask the
pharmacist to call Heritage Health Solutions
Customer Care Center at 1-866-265-0124,
representative will qualify the request by
asking a few questions. No controlled drugs
will be processed under this program. If a
controlled drug is needed, please contact
the Brooklyn VAMC Emergency Department.
VA Nurse Help Line: Call
1-866-940-2877 to speak to a registered
nurse if you experience any symptoms or have
any health related questions.
Centralized scheduling:
Call 1-877-877-9267 for questions about an
appointment at the Manhattan VA or to
schedule an appointment.
Mental health help desk:
718-836-6600 extension 3742
U.S. Army Veteran; Communications
Specialist, Veterans Benefits Administration
When Elizabeth and Joey were choosing a place to
call home for the next chapter of their lives, they
didn’t know that they would be the 20 millionth
family to receive a home loan guaranteed by VA.
U.S. Army Veteran; Communications
Specialist, Veterans Benefits Administration
Last week, VBA held a Twitter Town Hall on Home
Loans and Specially Adapted Housing. What would you
like to talk about in next months Twitter Town Hall?
There are now two million Veterans and service
members using the online tool eBenefits to access
information about their military and Veteran
benefits. This month, we launched even more
features.
Director, National Veterans Creative Arts
Festival
During the next week, hundreds of artists and
spectators will walk through the Great Hall of the
Massachusetts State House in Boston viewing
remarkable sculptures, paintings and carvings.
It’s football season, and that means tailgating,
whether you are at the game or in your own backyard.
Too often this means high calorie, high fat foods
and way too much of them.
U.S. Air Force Veteran; Communications
Specialist, Veterans Benefits Administration
More than 8 million women in the United States
have heart disease. So many in fact, that heart
disease is the number one killer of women, killing
nearly 500,000 every year.
Mark is a father. He’s also a Caregiver for
his son. “Each day is a blessing to have my son
with me.”
His love for his Veteran son is very evident
in this video.
And his message to other family caregivers
out there is: “Stay strong.”
VA recognizes the crucial role that family
caregivers play in helping Veterans recover from
injury and illness in the daily care of Veterans
in the community.
VA values the sacrifices family caregivers
make to help Veterans remain at home. Caregivers
are our partners and we are dedicated to
providing them with the support and services
they need.
VA has long provided services to support
family caregivers. The Caregivers and Veterans
Omnibus Health Services Act of 2010 has allowed
VA to provide additional unprecedented benefits
and services to family caregivers, including
enhanced benefits for family caregivers of
seriously injured post 9/11 Veterans.
Caregiver Support Coordinators
VA has Caregiver Support Coordinators at each
VA medical center who serve as the clinical
experts on caregiver issues. They know all about
VA and non-VA support services and benefits
available for Veterans of all eras and their
family caregivers.
Caregiver Support Coordinators can also
assist eligible Post 9/11 Veterans and their
caregivers in applying for additional services.
Caregivers are our partners. We are dedicated to
providing them with the support and services
they need.
VA’s National Caregiver Support Line —
855-260-3274 — is available to respond to
inquiries about caregiver services and is a
resource and referral center for caregivers,
Veterans and others seeking caregiver
information.
The Caregiver Support Line has received more
than 55,000 calls and responds to an average of
150 calls per day.
Stipend and Benefits Information
VA accepts applications for the Program of
Comprehensive Assistance for Family Caregivers
(for seriously injured post 9/11 Veterans) by
mail, telephone and online.
VA has paid out more than $87 million in
stipends to family caregivers in the program
since July 2011 when the first stipend payments
were made.
VA provides comprehensive family caregiver
training for eligible family caregivers in the
stipend program. To date, more than 7,800 family
caregivers have completed this training.
Caregiver Support Program Website
VA has a website dedicated to
family caregivers. The site provides
caregiver stories, resources, and a ZIP code
look up feature that allows caregivers to
identify their local Caregiver Support
Coordinator.
Hurricane Sandy reached the mid-Atlantic coast of the U.S. on
October 29, 2012.
EPA is continuing to assist FEMA in the Hurricane Sandy Response to
help ensure the protection of public health and the environment. We
are providing technical assistance to the states of New Jersey and
New York by assessing impacted drinking water and wastewater
facilities, assisting the U.S. Army Corps of Engineers and New York
City officials on dewatering activities of transportation
infrastructure, and evaluating requests for fuel waivers. We will
continue to provide updates and information on this site as
available.
As
East Coast residents begin the process of
rebuilding after Hurricane Sandy, we want to be
sure you know what to do if your benefits were
affected.
If you
have been displaced by Hurricane Sandy, you
should change your contact address with VA. You
can do this
within eBenefits,
by contacting your closest
VA Regional Office,
or calling 1-800-827-1000.
If you have a VA
Guaranteed Home Loan and that home received
storm damage, you should read
this fact sheet.
The fact sheet also contains information for
mortgage lenders and servicers regarding loans
for homes guaranteed by VA that might have been
damaged by Sandy.
If you receive monthly
payments from VA, such as disability
compensation, GI Bill living stipend, or others,
you should experience no delay in payment if you
receive an electronic funds transfer (EFT).
Benefits due on November 1 were distributed as
normal and should be available to you.
If you are in an
impacted area and receive a monthly paper check
through the mail, there is a possibility your
check could be delayed or undeliverable as a
result of storm damage. If you have not yet
received a scheduled payment, call our toll-free
number: 1-800-827-1000. Additionally, if you are
experiencing financial hardship, you can visit a
VA Regional Office
and obtain a replacement check. However, please
call our toll-free number and speak with a call
agent before visiting a regional office.
It’s important to
remember that obtaining a replacement check can
result in a duplicate payment. If you receive a
replacement check and then later receive your
original check, you should return the original
to the
U.S. Treasury.
Not returning the check could result in
non-payment of benefits the following month.
If you aren’t sure how
Hurricane Sandy may have affected the delivery
of your check, call the U.S. Postal Service at
1-800-ASK-USPS (1-800-275-8777) for the latest
information on post office services. Customers
can also get the latest post office service
information
on the web.
Health and Human Services (HHS) Secretary
Kathleen Sebelius today announced the final rule implementing the part
of the health care law that delivers higher payments to primary care
physicians serving Medicaid beneficiaries. The new rule raises rates to
ensure doctors are paid the same for treating Medicare and Medicaid
patients and does not raise costs for states.
USDA Mobilizes to Assist Those Affected by Hurricane Sandy
Department Moves to Support FEMA-Led Recovery Effort
WASHINGTON, Oct. 31, 2012--The U.S. Department of
Agriculture (USDA) is taking steps in coordination with the
Federal Emergency Management Agency (FEMA) to assist those
affected by Hurricane Sandy. In addition to working with
FEMA and other departments, agencies, state and local
governments, USDA is also reaching out to farmers and
ranchers in states affected by recent extreme weather.
In the aftermath of Hurricane Sandy, USDA personnel are
working in the following areas:
USDA Forest Service
(FS) wildfire suppression crews and incident management
teams are being mobilized and sent to the East Coast to
support state and local partners as they respond to
Hurricane Sandy. Currently, six incident management
teams and eleven wildfire suppression crews, a total of
more than 250 personnel, are staged in or en route to
New York, Pennsylvania, New Jersey, Massachusetts, and
Washington, D.C in coordination with local emergency
managers. Wildfire suppression crews and incident
management teams typically perform tasks such as
clearing downed trees from roads so that local
responders can conduct search and rescue missions;
assisting at Federal Emergency Management Agency (FEMA)
logistics facilities that provide water and other
commodities needed to sustain life; providing
communications equipment and support to local emergency
response agencies; and command and control support for
emergency response agencies.
USDA Rural Development
(RD) staff is reaching out to all telecommunications,
electric and water system borrowers in areas affected by
Hurricane Sandy to assess any damages and offer full and
immediate assistance where necessary. RD is working with
members of the National Rural Electric Cooperatives
Association (NRECA) to determine how to most effectively
meet requests for assistance to help restore power and
with the National Rural Water Association (through their
state associations) and 38 Circuit Riders funded through
an existing USDA contract, to help rural communities
assess water system outages and damages. Also, RD has
given approval for Circuit Riders in states that were
not affected to travel to the affected area to assist in
recovery efforts.
USDA Rural Development
(RD) has also updated its list of available housing
units suitable for emergency shelter and has provided
this information to FEMA.
USDA Natural Resources Conservation Service
(NRCS) also announced that it is advancing Emergency
Watershed Protection technical assistance funds to 10
States in the affected region to assist in disaster
recovery.
USDA Food and Nutrition Service
(FNS) has reached out to state partners to offer food
assistance to those in need in areas affected by a
disaster. At present, affected states are assessing
their needs and no formal requests for assistance have
been received. However, FNS fully expects to receive
requests from affected states as they complete their
assessments and determine what response best meets the
needs of their citizens. FNS will continue to work
closely with the affected states to provide support and
technical assistance as needed. FNS may provide food
assistance during disasters in the following ways:
providing USDA Foods to state agencies for distribution
to shelters and other mass feeding sites; providing USDA
Foods to state agencies for distribution directly to
households in need in certain limited situations; and
authorizing state agencies to issue Disaster
Supplemental Nutrition Assistance Program (D-SNAP)
benefits.
USDA Food Safety and Inspection Service
(FSIS) is monitoring the regulated meat, poultry, and
processed egg product industry to ensure FSIS' regulated
products are safe for consumers. FSIS has published food
safety messages for consumers.
USDA Animal and Plant Health Inspection Service
(APHIS) has deployed animal care experts to provide
pet-liaison services to FEMA in Philadelphia, as well as
a plant pest expert to the Massachusetts State Emergency
Operations Center to provide information and guidance on
Asian Long Horned Beetle quarantines to FEMA's Incident
Management Assistance Teams as they plan for debris
removal. APHIS Animal Care is coordinating with the
National Animal Rescue and Sheltering Coalition (NARSC)
and the National Alliance of State Animal and
Agriculture Emergency Programs (NASAAEP) who are staging
a distribution center at the State Fairgrounds in
Syracuse, NY with supplies for companion animals.
USDA Farm Service Agency
(FSA) today urged producers in need or those with
questions to contact their local county or state USDA
Service Center or Farm Service Agency office for
assistance and to keep thorough records of all losses,
including livestock death losses, as well as additional
expenses for such things as feed purchases and
extraordinary costs because of lost supplies and
temporary shelters or transportation. Producers with
damaged farmland should also contact their local FSA
office. The Emergency Conservation Program (ECP) may be
able to assist producers who need to repair farmland or
remove debris. FSA currently has $15.5 million available
for counties that received a Major Disaster declaration.
USDA's Risk Management Agency
reminds producers faced with questions on prevented
planting, replant, or crop losses to contact their crop
insurance agent for more information. USDA encourages
all farmers and ranchers to contact their crop insurance
companies and local USDA Farm Service Agency Service
Centers, as applicable, to report damages to crops or
livestock loss. More information about federal crop
insurance may be found at
www.rma.usda.gov.
Additional resources to help farmers and ranchers deal
with flooding and other damage may be found at
www.usda.gov/disaster.
USDA is an equal opportunity provider and employer. To file
a complaint of discrimination, write: USDA, Office of the
Assistant Secretary for Civil Rights, Office of
Adjudication, 1400 Independence Ave., SW, Washington, DC
20250-9410 or call (866) 632-9992 (Toll-free Customer
Service), (800) 877-8339 (Local or Federal relay), (866)
377-8642 (Relay voice users).
A Message to
Family Caregivers
from
Laura Taylor,
Director, National Caregiver Program
Deborah Amdur,
Chief Consultant, Care Management and Social Work Services
Department of
Veterans Affairs
Family
Caregivers Matter! November is National Family Caregivers Month; a time to
celebrate and recognize the multiple roles and responsibilities of so many
Family Caregivers of Veterans and the many ways in which you matter - to the
Veteran you care for, to your family and community, to your Veteran’s VA health
care team and to the nation.
Being a
Caregiver often means that you, the Family Caregiver, put your own needs last,
at the end of a never ending list of “things to do." This month, why not treat
yourself by putting an enjoyable activity, just for you, at the top of your
“to-do” list? Throughout the month, Caregiver Support Coordinators across the
country will be holding special events for Caregivers of Veterans to say thank
you for all you do and re-affirm the importance of the care you provide. Check
out the Family Caregiver month activities at your local VA Medical Center. You
can locate your Caregiver Support Coordinator (CSC) on the Caregiver Support
website
www.caregiver.va.gov
by simply entering your zip code. If you are not able to attend an event, the
website has information on “Staying Strong” and “Caring for Yourself." You will
find information on maintaining your physical and emotional well being including
instructions for, practicing mindfulness, deep breathing, meditating and
journaling to reduce stress.
In November,
we honor our Veterans and give thanks for our many blessings, it is fitting that
also in this month, we, as a nation, recognize the steadfast dedication of
Family Caregivers to the health and well being of the Veterans you care for.
Your body has its own network of tiny, coordinated biological
clocks that are responsible for our circadian rhythms.
Researchers are identifying the genes and proteins that run
these clocks and figuring out exactly how they help keep daily
rhythms in synch. Read more...
You received this message because you are subscribed to Inside
Life Science – a series that brings you inside the science of
health from the National Institute of General Medical Sciences.
US Federal Contractor Registration: Understanding No Bid Contracting No Bid Contracting is a “contract which is
given out on the basis of the contracting party’s beliefs that this
is the best contractor, best price, highest quality work to be had,
or because there is a networking connection between the contracting
party and the contractor.” In order for your business to become
registered for federal employment and be eligible to pick up no bid
contracts with FEMA, you must register for a DUNS number (Dun and
Bradstreet) and register under SAM (System for Awards Management).
Vendors must complete a FEMA Vendor Profile in addition to SAM
registration. US Federal Contractor Registration is currently
offering a free evaluation and review of vendors' government
registration, including their SAM registration. To receive this free
evaluation, interested businesses should contact the toll free
Contractor Helpline at (877) 252-2700 ext 1. Placement Specialists
can also answer questions contractors may have about the new System
for Award Management or current federal procurement opportunities.
The following have been posted to the EHC
Program Web site:
Draft Reports
The following draft reports are available for
comment until November 28, 2012:
Happy Halloween! Bats might be considered spooky by some, but there are a vital
part of our ecosystem. There are more than 1,100 species of bats and they can be
found on every continent except Antarctica. Only three species of bats suck
blood. Most eat insects – small bats can eat up to 2,000 insects every night,
saving many crops from being destroyed.
About 30 percent
of bat species eat fruit, pollen or nectar. Bananas, dates, coconut, cloves,
vanilla, Brazil nuts and avocados all depend on bats for pollination. Bats help
spread seeds for nuts, figs, allspice and cacao, from which chocolate is made.
Fruit bats eat the cacao fruit and discard the bean, which grows into a new
tree.
Alabama’s Fern Cave National Wildlife Refuge
is the largest known hibernation cave for gray bats. Between 800,000 and one
million gray bats winter here. Bat experts also believe as many as one million
Indiana bats may be using Fern Cave. Another 300,000 gray bats roost in Sauta Cave National Wildlife Refuge,
also in Alabama.
Photo: USFWS
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More tanning bed cancers
U.S. Dept. of Health & Human Services sent
this bulletin at 10/31/2012 10:11 AM EDT
Tanning beds can raise your risk of the
deadly skin cancer, melanoma – and,
researchers now say, your risk of other
forms of skin cancer – not as often deadly,
but damaging to your looks.
At the University of California, San
Francisco, Eleni Linos reviewed data from
articles involving about 80,000 people.
FDA-Funded Study Confirms Increased Risk of Blood Clots with Use of Yaz,
Yasmin and Other Drospirenone-Containing Birth Control Pills Parker Waichman LLP is notifying the public about
new research confirming the association between blood clots with the use
of drospirenone-based birth control pills such as Yaz and Yasmin. The
latest study, which was funded by the U.S. Food and Drug Administration
(FDA) and conducted at Kaiser Permanente Northern California Division of
Research, found that women who take these oral contraceptives are twice
as likely to suffer from arterial thrombotic events (ATE) and 77 percent
more likely to experience venous thromboembolic events (VTE). These
conditions have potentially fatal consequences, and are cited in
numerous Yaz and Yasmin personal injury lawsuits.
Bisnar | Chase: Monrovia Police Urge Residents to Follow Posted Speed
Limits in School Zones California pedestrian accident lawyer joins local
police agencies in encouraging residents to slow down and adhere to
posted speed limits in school zones. Taking much-needed safety measures
in school zones will greatly help reduce the number of tragic pedestrian
accidents that occur near or around our schools, says John Bisnar,
founder of the Bisnar | Chase personal injury law firm.
That’s
why I take such pride in FDA’s proposal of two rules that
set science-based standards for the prevention of foodborne
illnesses. One will govern facilities that produce food, and
the other concerns the safety of produce.
