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Tuesday November 10, 2009 |
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NEWS: BUSINESS
1107 Online flu seminar
for business to prepare for impact of H1N1 flu [Scotland]--Help
to enable Scottish businesses prepare for the impacts of
swine flu will be offered through an innovative,
free-to-access, online seminar.
1107 Digital 'plaster'
for monitoring vital signs undergoes first clinical trials
[London England]--A wireless digital 'plaster'
that can monitor vital signs continuously and remotely is
being tried out with patients and healthy volunteers at
Imperial College Healthcare NHS Trust, in a new clinical
trial run by Imperial College London researchers.
1103 FDA publishes guidance on diagnostic tests for H1N1 flu virus [United States]--The U.S. Food and Drug Administration today published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic, manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA).
If granted, the EUA will allow
the test to be used during the national public health
emergency declared by Department of Health and Human
Services Secretary Kathleen Sebelius in April. This guidance
document outlines what information the FDA recommends that
manufacturers include in these EUA requests. The EUA
authority allows the FDA to authorize use of unapproved or uncleared medical
products or unapproved or uncleared uses of approved or cleared medical
products following a declaration of emergency, when certain criteria are
met. The authorization ends when the declaration of emergency is terminated
or the authorization is revoked by the FDA. The EUA authority is part of Project BioShield, which became law in July
2004. While the FDA encourages manufacturers to submit appropriate premarket
applications for these tests, the agency also recognizes that it may not be
possible to generate complete clinical validation data that would normally
be included in an application. However, this guidance outlines information
the FDA recommends be included, and the FDA gives these requests thorough
and careful review to protect the public health. During this declared public health emergency, manufacturers of 2009 H1N1
influenza virus tests that are unable to submit a complete premarket
notification may use the guidance to submit a request for an EUA. The guidance document is part of the FDA’s ongoing efforts to provide
public health authorities managing the pandemic with reliable and accessible
diagnostic tests. The guidance is
available online and will
remain in effect throughout the public health emergency. For more information: The FDA’ Emergency Use Authorization of Medical Products
1023 Got the flu? Now
is not the time for a sick note: Ontario's doctors [Toronto
ON]--In advance of what is shaping up to be an
unprecedented flu season, Ontario's doctors are encouraging
employers to reconsider asking their employees for a sick
note from a physician because of an absence from work. While
Ontario's doctors are asking employers to trust their
employees, they are stressing that employees shouldn't take
advantage of this year's flu situation as an opportunity to
simply take a day off.
1020 FDA approves
seasonal flu vax Fluarix for pediatric use [Rockville MD]--The
U.S. Food and Drug Administration today approved use of the
seasonal influenza vaccine Fluarix for children ages 3 years
to 17 years. Previously, this vaccine, which contains
inactivated (killed) influenza A and B viruses, had been
approved for use in adults, ages 18 years and older. The
safety and effectiveness of Fluarix for use in children ages 3 years and
older is documented by a U.S. study comparing 2,115 children who received
Fluarix with 1,210 children who received Fluzone, a different influenza
vaccine already licensed by the FDA for use in children ages 6 months and
older. Study results showed that children 3 years and older vaccinated with
Fluarix and Fluzone produced similar amounts of antibodies in the blood at
levels considered likely to be protective against seasonal influenza. Fluarix is a seasonal influenza vaccine not intended to protect against
the 2009 H1N1 influenza virus. "This approval of an additional seasonal influenza vaccine for children
provides help in protecting them against influenza,” said Karen Midthun,
M.D., acting director of the FDA’s Center for Biologics Evaluation and
Research. “Children are very vulnerable to the influenza virus and are more
likely to be hospitalized for associated problems.” With today’s approval, there are now four companies approved by the FDA
to manufacture seasonal influenza vaccine for use in children. Influenza is far more dangerous than the common cold for children, who
often require medical care, especially if they are younger than 5 years. It
is best to vaccinate children each fall, but vaccination also can occur in
the winter months when influenza season often peaks. Common adverse events experienced after administration of Fluarix are
typical of those for flu shots and include pain, redness, and swelling at
the injection site as well as irritability, loss of appetite, and
drowsiness. Because Fluarix contains a small amount of egg protein, it should not be
administered to anyone allergic to eggs or egg products. Fluarix is manufactured by GlaxoSmithKline Biologicals of Dresden,
Germany. For more information: FDA Web site on Influenza Virus Vaccine Safety and Availability
1020 FDA, FTC issue
joint warning letter to website offering fraudulent H1N1 flu
supplements [Washington DC]--On October 15, 2009,
the U.S. Food and Drug Administration (FDA) and the Federal
Trade Commission (FTC) issued a joint warning letter to a
Web site marketing fraudulent supplements that claim to help
prevent the spread of the 2009 H1N1 influenza virus. The
warning letter, the first to be issued jointly by the agencies, advises the
owners of the site that they must discontinue the fraudulent marketing of
their product or face legal action. The letter further advises the owners of
the site that they have 48 hours to give the agencies a plan to discontinue
their fraudulent marketing. The FDA and the FTC remind consumers to be cautious of promotions or
Internet sites offering products for sale that claim to diagnose, prevent,
mitigate, treat or cure the 2009 H1N1 influenza virus. Fraudulent H1N1
influenza products come in many varieties, including dietary supplements, as
well as products purporting to be drugs, medical devices or vaccines. Since
May 2009, the FDA has warned more than 75 Web sites to stop the sale of more
than 135 products with fraudulent H1N1 influenza virus claims. “Products that are offered for sale with claims to diagnose, prevent,
mitigate, treat or cure the 2009 H1N1 influenza virus must be carefully
evaluated,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D.
“Unless these products are proven to be safe and effective for the claims
that are made, it is not known whether they will prevent the transmission of
the virus or offer effective remedies against infection. Furthermore, they
can make matters worse by providing consumers with a false sense of
protection.” The FDA and the FTC also warn consumers to take extreme care when buying
products over the Internet that claim to diagnose, prevent, treat or cure
the H1N1 influenza virus because, in addition to being fraudulent, they
could be dangerous. In collaboration with the FTC, the FDA will continue to work aggressively
to identify, investigate and take regulatory action against individuals or
businesses that wrongfully promote purported 2009 H1N1 influenza products. This will include taking joint action, when appropriate, such as the
issuance of last Thursday's warning letter. Additional legal action could
include an injunction or issuance of an administrative order by the FTC or
seizure of products, an injunction or criminal prosecution by the FDA. “The FDA continues to consider the sale and promotion of fraudulent H1N1
influenza products to be a possible threat to the public health and in
violation of the Federal Food Drug and Cosmetic Act,” said Michael Chappell,
acting associate commissioner for regulatory affairs. “The FDA has an
aggressive surveillance program to detect fraudulent H1N1-related products
and will take prompt action to stop the marketing of fraudulent H1N1
influenza products and will hold those who are responsible for doing so
accountable.” To view the warning letters, visit: There are two antiviral drugs approved by the FDA for treatment and prophylaxis of the 2009 H1N1 influenza virus – Tamiflu (oseltamivir phosphate) and Relenza (zanamivir). Tamiflu and Relenza, in addition to their approved labeling, have been issued Emergency Use Authorizations by the FDA that describe specific authorized uses during this public health emergency. H1N1 Flu Fraud Widget This week, the FDA enhanced its efforts to warn the public about potentially deceptive H1N1 influenza products and to report suspected criminal activity with the release of an H1N1 flu fraud widget. The portable application, embedded in a Web page that can be copied onto any other Web site or blog, will allow the public to play an active role in preventing flu fraud, and is available at http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm186340.htm Consumers are urged to report any suspected fraudulent products or criminal activity relating to FDA-regulated products associated with H1N1 influenza virus, including the names of Web sites that may be offering these products for sale, to the FDA by visiting: http://www.accessdata.fda.gov/scripts/email/oc/oci/flucontact.cfm Consumers are urged to purchase and consume only FDA-approved or authorized medical products to diagnose, treat, prevent, or cure infections caused by the H1N1 virus. Consumers also are urged to contact their health care provider if they have any questions or concerns about medical products or personal protective equipment. For more information: FDA 2009 H1N1 (Swine) Flu Page Centers for Disease Control and Prevention
– 2009 H1N1 Flu (Swine Flu) Fraudulent 2009 H1N1 Influenza Products
List Influenza Antiviral Drugs and Related
Information The Federal Government’s Influenza Web site FTC Warns Internet Peddlers that
Potentially Bogus H1N1 Influenza Products May Violate Federal Law—Press
Release, May 5, 2009
1017 DHSS offers online education webinar for H1N1 [New Jersey]--Beginning today, the Department of Health and Senior Services (DHSS) has added to its website a free, online pandemic influenza webinar to educate individuals on pandemic influenza preparations. The webinar is available in both English and Spanish on the DHSS website at www.nj.gov/health/training/panflu.
"Learning the facts about pandemics and planning ahead are important elements of pandemic flu preparedness," said Health and Senior Services Commissioner Heather Howard.
“As we continue to monitor the resurgence of
H1N1 influenza this fall, it’s important that all
While appropriate for all New Jerseyans, the webinar specifically targets employees and employers. It can be taken as an online course, downloaded onto CDs or an organization’s intranet, or by printed copy.
Upon completion of the webinar users should: · Understand the impact a flu pandemic may have in a community and what community leaders may need to do to reduce the impact · Be able to develop a Pandemic Flu Personal Emergency Plan · Know how to reduce your risk of getting the flu and spreading it to others · Know how to provide flu care at home · Understand where you can get help for the emotional stress a flu pandemic may cause · Know how to identify reliable sources of public health information
The webinar was funded by the New Jersey
Office of Homeland Security and developed by DHSS and
1015 DHS Sec announces
new proposed standards for private sector preparedness [USA]--Department
of Homeland Security (DHS) Secretary Janet Napolitano today
announced new proposed standards for a 9/11
Commission-recommended program for the private sector to
improve preparedness for disasters and emergencies.
"Preparedness is a shared responsibility and everyone—including businesses,
universities and non-profit organizations—has a role to play," said
Secretary Napolitano. "Ensuring our private sector partners have the
information and training they need to respond to disasters will strengthen
our efforts to build a culture of preparedness nationwide." DHS published a notice in the Federal Register today seeking public
comment on three new standards identified for adoption under the Voluntary
Private Sector Preparedness Accreditation and Certification Program
(PS-Prep). PS-Prep is a partnership between DHS and the private sector that
enables private entities—including businesses, non-profit organizations and
universities—to receive emergency preparedness certification from a DHS
accreditation system created in coordination with the private sector. The notice proposes new PS-Prep standards to enhance operational
resilience, business continuity management, and disaster and emergency
management among participating private sector partners. The proposed standards, developed by the National Fire Protection
Association, the British Standards Institution and the ASIS International,
were selected based on their scalability, balance of interest and relevance
to PS-Prep from a group of 25 standards proposed for consideration following
the publication of a Federal Register notice in December 2008 announcing the
program. In addition to the standards in the notice posted today, DHS is
establishing classifications and methods of certifications that recognize
the unique needs and characteristics of small businesses. Individuals wishing to submit comments on the proposed standards,
recommend additional standards for consideration or comment on other
programmatic aspects of PS-Prep may obtain a comment form and instructions
for submission online at For more information, visit http://www.fema.gov/privatesectorpreparedness/.
1009 H1N1 Govt helping
workplaces prepare [Saskatchewan]--Beginning
today, the government is distributing a new guide to
workplace pandemic influenza preparedness. Hard copies of the guide can be requested from Occupational Health and
Safety. The guide is also available online. "Employers and workers have an important role in preparing for and
preventing the spread of pandemic influenza in their workplaces," Advanced
Education, Employment and Labour Minister Rob Norris said. "This guide
identifies the practical steps employers and workers can take together to
prepare for and prevent pandemic influenza in their workplaces." The guide was adapted from a similar guide produced in Alberta with input
from their ministries responsible for Occupational Health and Safety and for
public health. Saskatchewan partners consulted in the development of this guide include
the Ministry of Health, Regional Health Authorities, and the Occupational
Health and Safety Council. To order copies, or for more information on H1NI influenza and
Occupational Health and Safety in Saskatchewan, call toll-free at
1-800-567-7233 or visit
1009 H1N1 Flu
communication toolkit for businesses presented [Virginia]--State
Health Commissioner Karen Remley, MD, MBA addressed an
audience of 725 Human Resource professionals at the Virginia
Society for Human Resource Managers (SHRM) conference in
Virginia Beach where she presented a novel H1N1
communication toolkit for businesses. Joining Dr. Remley was
Cindy Hale, President of Virginia SHRM. Dr. Remley said
“It is difficult to predict the severity of illness the novel H1N1 flu will
cause, therefore businesses should plan to respond in a flexible way and be
prepared to take additional steps to decrease the spread of flu in the
workplace.” Dr. Remley also stated, “Public health communicators realize
that in addition to traditional fact sheets, posters and brochures, various
forms of templated social media tools such as text messages, eCards,
e-mails, and website widgets are needed to meet the demands of today’s
audiences.” “Employers, in general, play a key role in protecting employees' health
and safety, as well as in limiting the negative impact of influenza
outbreaks on the individual, the community, and the nation’s economy,”
stated Ms. Hale. “Employers who have developed pandemic plans should review
and revise their plans as outlined in the toolkit in light of the current
novel H1N1 influenza outbreak,” she added. Consistent messaging is important and the Department of Health cannot
reach everyone to raise awareness of this issue. “We see it as our
obligation as Human Resource professionals to use the recommendations
provided in the toolkit to ensure a minimal impact to our staff and our
community,” remarked Ms. Hale. Actions employers should take include:
Encourage your employees to get their seasonal flu vaccination now and their
novel H1N1 vaccination when it becomes available. Commissioner Remley added, “We need to remain vigilant against the spread
of the disease. We are focused on monitoring the activity of the virus in
our state and on reducing its impact, especially among those at highest risk
for complications.” For more information, go to:
Virginia Department of Health – H1N1
Hotline: 1-877-ASK-VDH3 (1-877-275-8343) Communication Toolkit for Businesses and Employers 2009 H1N1 Flu Resources for Businesses and Employers
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Headlines link directly to articles: 1107 Online flu seminar for business to prepare for impact of H1N1 flu [Scotland] 1107 Digital 'plaster' for monitoring vital signs undergoes first clinical trials [London England] 1103 FDA publishes guidance on diagnostic tests for H1N1 flu virus [United States] 1023 Got the flu? Now is not the time for a sick note: Ontario's doctors [Toronto ON] 1020 FDA approves seasonal flu vax Fluarix for pediatric use [Rockville MD] 1017 DHSS offers online education webinar for H1N1 [New Jersey] 1015 DHS Sec announces new proposed standards for private sector preparedness [USA] 1009 H1N1 Govt helping workplaces prepare [Saskatchewan] 1009 H1N1 Flu communication toolkit for businesses presented [Virginia] |
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