CONTENTS:
- Medical Devices
- Drugs & Biologics
- Food & Dietary Supplements
- Tobacco
Medical Devices
Verax Biomedical gets FDA OK for platelet
PGD test
The FDA has granted Verax Biomedical clearance to label and market
its Platelet PGD test as a safety measure for blood platelet
transfusions. The $30 assay, which is being marketed by Fenwal
globally, takes less than 30 minutes to spot bacterial
contamination in platelets prior to transfusion.
Optos to acquire Opko's
instrumentation division for $17.5 million
Scotland-based Optos hopes to expand its product portfolio by
agreeing to buy Opko Health's ophthalmic instruments division
for $17.5 million, plus royalties. The buyout, which is expected to
be completed during the fourth quarter, will allow Optos to improve
its diagnostic systems by integrating its retinal imaging device
with Opko's OCT SLO technology.
Zoll Medical CEO talks about Medicare
payment change for LifeVest
A Medicare reimbursement change for Zoll Medical's LifeVest
wearable defibrillator would affect only 8% of the company's
total sales, CEO Richard Packer said at the recent UBS Global Life
Sciences Conference. Restricting doctors' access to the device,
which can prevent sudden cardiac arrest after a heart attack, would
remove "the only tool cardiologists have to maintain ICD
implants within guidelines," he said.
Cardiovascular diagnostics firm
restructures C-suite team
CardioDx has appointed Andrew Guggenhime, former chief financial
officer at Calistoga Pharmaceuticals, as its CFO and Mark Monane,
former executive at Needham, as chief medical officer. The Palo
Alto, Calif.-based company is the maker of the Corus CAD gene
expression assay designed to help doctors diagnose obstructive
coronary artery disease.
CDC backs nucleic-acid testing for organ
transplants
The CDC has released new draft guidelines aimed at preventing the
transmission of infectious diseases, including HIV and hepatitis,
through organ transplants. As part of the guidance, the agency has
recommended the use of nucleic-acid testing no more than seven days
before organ recovery. The guidelines also include a modified list
of donor risk factors.
Toshiba's M-Power interface secures
FDA clearance
Tustin, Calif.-based Toshiba America Medical Systems has obtained
FDA clearance for its M-Power interface, an MR system designed to
streamline the scanning process. The device will be used in
combination with Toshiba's Titan 3T, Vantage Atlas and Vantage
Titan 1.5 systems.
Kips Bay Medical hits regulatory bump for
surgical mesh
The FDA has asked Kips Bay Medical to submit additional data to
back its application for an investigational device exemption to
start clinical studies of its eSVS surgical mesh, which is designed
for use in coronary artery bypass operations. The company's
shares fell 34% on the news.
Medtronic wins $101.2 million in patent
infringement lawsuit
A California jury has awarded Medtronic $101.2 million in damages
as a result of a lawsuit filed against NuVasive for purportedly
infringing patents of Medtronic's spinal implants. NuVasive,
which will receive $660,000 in damages for Medtronic's alleged
infringement of one of its patents, pledged to challenge the
jury's verdict.
Varian Medical to acquire Calypso for $10
million
Calypso Medical Technologies, which develops real-time
tumor-monitoring software and devices, will be acquired by Varian
Medical Systems for $10 million in cash, plus earn-outs. The deal,
which is expected to close early next month, would boost growth for
Varian in the motion management technology arena, said Timothy
Guertin, company president and CEO.
Spinal device firm hopes to raise $20.1
million in stock offering
Wilmington, N.C.-based TranS1 is selling 6.2 million shares of its
stock for $3.25 apiece in an offering slated to close Monday. The
company seeks to obtain as much as $20.1 million from the offering,
which it will use to fund clinical studies of its surgical tools
designed to treat degenerative spinal disorders in the lower lumbar
region.
Former Wright Medical exec joins Intrinsic
as CEO
Intrinsic Therapeutics, a Woburn, Mass.-based maker of the
Barricaid spinal implant designed to treat herniated lumbar discs,
has appointed Cary Hagan as president and CEO. Hagan, a former
executive at Wright Medical, replaces Greg Lambrecht, who will
remain as Intrinsic's executive director.
GI Dynamics brings weight loss device to
Austria
GI Dynamics said its EndoBarrier gastrointestinal sleeve, which is
designed to treat obesity and type 2 diabetes, has been released in
Austria. The Lexington, Mass.-based firm also established the
Hallein Clinic and Barmherzige Brüder Hospital to serve as
"Centers of Excellence" for implanting the device.
Carl Zeiss Meditec to boost sales in Spain
with IMEX unit buy
Germany-based Carl Zeiss Meditec has agreed to buy the intraocular
lens and ophthalmic viscoelastic devices unit of IMEX for about $12
million, plus earn-outs. The acquisition will allow Carl Zeiss to
expand its sales, support and service operations in Spain.
MITA wins $200K grant to boost U.S.
imaging device exports
The Commerce Department has awarded the Medical Imaging &
Technology Alliance $200,000 to help boost U.S. exports of imaging
tools and allow entry into Chinese and Indian markets. The grant
will bolster MITA's ability "to bring innovative imaging
technologies to market, improve global access to life-saving
therapies and diagnostic equipment and create good-paying jobs
right here at home," said Dave Fisher, the alliance's
executive director.
Siemens launches adjustable fluoroscopy
device
Siemens has developed a device called Luminos Agile, an X-ray
system that features a dynamic flat detector and an adjustable
table. The device is designed to make it easier for providers to
carry out fluoroscopic and radiologic tests on patients with
mobility problems.
MedX Health gets FDA OK for skin imaging
system
The FDA has granted MedX Health approval to market its MoleMate
skin imaging tool, which utilizes a hand-held device that uses
light to allow doctors to view and examine lesions and suspicious
moles.
FDA workshop will spotlight MRI
safety
The FDA will hold a workshop on Oct. 25 and 26 to explore ways to
reduce risks associated with MRI use. The workshop, which will take
place in Silver Spring, Md., will cover topics such as screening
patients with therapeutic implants, the effect of advanced
technology on MRI safety and ferromagnetic sensors.
Maquet wins regulatory approvals for
Sensation Plus catheter
The FDA has given Maquet Cardiovascular the go-ahead to market its
Sensation Plus 50cc 8 French catheter. The British Standards
Institution also granted CE Mark approval for the device, which
uses intra-aortic balloon counterpulsation therapy to treat
patients with heart conditions.
Wash. congresswoman: Get rid of 2.3%
device excise tax
Rep. Cathy McMorris Rodgers, R-Wash., at the first Jobs and
Innovation Forum, called on her fellow legislators to push for the
repeal of the 2.3% medical device excise tax set to begin in 2013.
Rodgers also urged making the FDA more efficient in order to make
innovative tools that "can reduce the cost of health care,
improve patients' lives and sustain American jobs" readily
available in the U.S.
Global telehealth market to soar to $6.28
billion in 2020
An InMedica report forecasts that the global market for telehealth
tools will reach $990 million in 2015 and $6.28 billion in 2020.
Growth will be driven in large part by an aging population and
pressure to reduce costly hospital stays. The founder of a Boston
startup sees a large potential market for the remote monitoring of
devices such as glucose meters and blood pressure cuffs that are
used to track chronic conditions.
Coalition calls for speedy review of
device identifier rule
The Advancing Patient Safety Coalition has asked the Office of
Management and Budget to expedite its review of the FDA's
proposal to create a unique identifier system for medical devices.
"It is imperative that OMB work expeditiously to release the
proposed UDI rule, as the rule is critical to patient safety
improvement initiatives and medical error reduction," the
coalition said in a letter to Jacob Lew, the OMB's
director.
C.R. Bard offers to buy ClearStream for
$68.5 million
C.R. Bard said it offered to pay about $68.5 million to acquire
ClearStream Technologies, an Irish maker of catheters designed for
angioplasty operations. The acquisition would allow Bard to
strengthen its foothold in the vascular medical device arena, said
Timothy Ring, company chairman and CEO.
Imricor Medical hopes to obtain $3 million
in funding
Minnesota-based Imricor Medical Systems said in a regulatory filing
that it is hoping to secure $3 million. The company is working on
an MRI-safe catheter system that can be used for the treatment of
atrial fibrillation and other types of cardiac rhythm
disorders.
Wright Medical hires former ev3 executive
as CEO
Robert Palmisano, former president and CEO at endovascular device
company ev3, has been named CEO of Wright Medical. Palmisano
replaces interim CEO David Stevens, who will remain as Wright's
board chairman.
NeuroMetrix launches neuropathy test for
the diabetes market
NeuroMetrix has commercially released its NC-stat DPNCheck test, a
point-of-care assay used in assessing diabetic peripheral
neuropathy and other systemic neuropathies. Similarly, the
company's reverse stock split has allowed it to regain
compliance with the minimum share price requirement of the NASDAQ
stock exchange.
AdvaMed details objection to IOM's
findings on 510(k) process
AdvaMed has maintained its objection to the Institute of
Medicine's proposal to scrap the 510(k) clearance process for
medical devices. "We strongly disagree with its central
recommendation to abandon the current 510(k) program and to replace
it at some unknown date with an untried, unproven, and unspecified
new legal structure," AdvaMed's Janet Trunzo said in a
statement.
FDA panel to review Medtronic's
Ablation Frontiers cardiac device
An FDA panel will consider Medtronic's premarket approval
application for its Ablation Frontiers cardiac ablation device on
Oct. 27. Medtronic last year secured approval in Canada to market
the device, which is used for the treatment of atrial
fibrillation.
Health groups file brief in support of
FDA's graphic tobacco warnings
Several health groups, including the American Cancer Society and
the American Academy of Pediatrics, have expressed their support to
the FDA's requirement that cigarette packs carry graphic
warning labels about the risks of smoking. The federal government
has a strong interest in bringing effective messages about the risk
of smoking to consumers, and that the "current warnings fail
to change consumers' decisionmaking or behavior," the
groups wrote in their friend-of-the-court brief. The brief comes
ahead of today's hearing on the free speech lawsuit by tobacco
companies.
Missouri smokers seek up to $1 billion in
damages against Philip Morris
Lawyers representing Missouri smokers have begun presenting their
arguments in a class-action lawsuit that claims that Philip Morris
International marketed light cigarettes as safer than regular
cigarettes. The plaintiffs are seeking as much as $1 billion in
damages against the tobacco firm. The trial, which opened in St.
Louis, is expected to end by late November.
Health Canada adopts new mandatory problem
reports policy
Effective Oct. 3, device makers and importers in Canada will be
required to submit mandatory problem reports to Health Canada
Vigilance-Medical Device reporting program. The new procedure will
affect companies with Medical Device Establishment Licenses and
those that have been accredited with the Canadian Medical Devices
Conformity Assessment System.
Rapid diagnostic test device can detect
malaria, dengue
U.S. and Indian researchers have developed a rapid diagnostic test
device that can detect several diseases, including malaria and
dengue. The device has shown 100% accuracy in laboratories and
could be modified to detect HIV, researchers said. Clinical trials
of the device are set to begin within a month.
Natus boosts presence in sleep diagnostics
with Embla acquisition
Embla Systems, the largest developer of tools for diagnosing sleep
apnea, has been acquired by Natus Medical for $16.1 million in
cash. The acquisition should allow Natus to expand its footprint in
sleep apnea diagnostics and move to the number one spot in the
international market for these devices, the San Carlos,
Calif.-based firm said.
Austin venture capital firm raises $133.8
million
Sante Ventures said in a regulatory filing that it has secured
$133.8 million as part of a funding round targeted at $150 million.
Among the companies in the venture capital firm's investment
portfolio are Terapio, a biopharmaceutical firm, and BioStable
Science & Engineering, which makes cardiovascular implants.
Funding round brings in $8.27 million for
blood glucose tech firm
Glytec said in a regulatory filing that it has obtained $8.27
million in a round of Series A financing led by Sea Dragon
Healthcare Partners. The company, which markets real-time systems
to manage a patient's blood glucose levels, will use the
proceeds to conduct further research and development as well as
boost growth in the U.S. and overseas.
BioBehavioral Diagnostics pulls in $3.1
million in debt financing
BioBehavioral Diagnostics has raised about $3.1 million in its
third round of debt financing this year. The company, which aims to
secure a total of $5.5 million, sells the Quotient ADHD System, a
test that can help diagnose attention-deficit/hyperactivity
disorder in 15 minutes.
Former Millipore executive is named CEO of
Quanterix
Quanterix, a developer of tools for the life science research and
in vitro diagnostics markets, has appointed Martin Madaus as
permanent CEO. Formerly the CEO of Millipore, Madaus had been
serving as acting CEO at Quanterix since June and as chairman since
October.
GE expands footprint in Russia with two
development deals
General Electric has entered two agreements in Russia focused on
the health care and energy sectors, which it says could yield $10
billion to $15 billion in sales. The health care contract will
allow GE to develop and market CT scanners and other diagnostic
tools with Russian Technologies.
Abiomed starts patient enrollment in trial
of Impella cardiac pump
Abiomed has begun patient enrollment for a clinical study of its
Impella heart pump for use in treating patients with heart tissue
death, without the need for electric shock. The device, which will
be tested in 60 patients from up to five clinical sites, was
cleared by the FDA in June 2008.
Mako shares rise after commercial launch
of surgical robotic arm
Mako Surgical has commercially released its RIO robotic arm, a
device cleared in February last year for use in total hip
replacement operations. The product's launch has bumped the
company's shares to 7% on Monday.
Atricure's Synergy device slated for
FDA panel review next month
An FDA panel is scheduled Oct. 26 to consider AtriCure's
premarket approval application for the device firm's Synergy
cardiac ablation system for use in atrial fibrillation treatment.
The panel is expected to make its recommendation to the FDA on the
day of review, and a final decision is expected by mid-2012, said
Julie Piton, Atricure's chief financial officer.
FDA's device center reorganizes its
top tier
The FDA's device center has named David Kalins acting deputy
director for regulatory affairs at the Office of Compliance. Thomas
Gross also has been selected as interim deputy director of the
Office of Surveillance and Biometrics, while Isaac Chang has been
appointed director of the OSB's postmarket surveillance
unit.
Intestinal liner holds promise for
obesity, type 2 diabetes
A small study presented at the European Society for the Study of
Diabetes found that using a duodenal-jejunal bypass liner, an
implantable weight-loss device, helped improve weight and blood
glucose levels in obese patients with type 2 diabetes.
Drugs & Biologics
Court stops Mylan from marketing a generic
of antibiotic Doryx
A federal court issued a preliminary injunction that blocks the
launch of Mylan's generic version of 150-milligram antibiotic
Doryx, made by Warner Chilcott. Warner showed a reasonable
likelihood of success in proving that Mylan violated a patent
covering the dose, the court said.
EU panel urges limited use of Sanofi's
heart drug Multaq
A European Medicines Agency panel recommended that Sanofi's
Multaq be prescribed only to certain patients with heart disease or
"after alternative treatment options have been
considered." Multaq, or dronedarone, was tied to increased
lung, cardiovascular and liver risk. The panel acknowledged
Multaq's benefit for nonpermanent atrial fibrillation.
Shire aims to end impasse on
Proamatine's conditional approval
Shire will seek a public hearing to end an impasse over the
FDA's post-marketing requirement for blood pressure medicine
Proamatine. The agency approved Proamatine in 1996 but required
Shire to conduct follow-up efficacy studies. "We now believe
the fastest way to get the final approval for this medicine is to
present our data at a public hearing, thereby sparing patients the
additional hardships of clinical trials," said Jeffrey Jonas,
senior vice president of research and development.
EU will investigate liver injury tied to
obesity drug orlistat
The European Medicines Agency will evaluate rare and severe cases
of liver injury that could affect the risk-benefit profile of
orlistat-based obesity drugs, such as Roche Holding's Xenical.
The agency said orlistat's liver risk is widely known, and the
investigation aims to assess the strength of evidence.
Experts ask FDA to track side effects of
antipsychotics on children
A panel of pediatric experts voted 16-1 to recommend that the FDA
continuously monitor the safety of antipsychotic treatments. The
committee specifically urged the FDA to make antipsychotics'
labels clearer by emphasizing their health risks to children, such
as weight gain and diabetes. In the next few weeks, the FDA is set
to issue a revised label for Bristol-Myers Squibb and Otsuka
Pharmaceutical's Abilify, an antipsychotic approved for use in
children. The label will cite metabolic risk and the latest
clinical studies, among other data, said an FDA official.
FDA issues clinical hold on cancer drug by
Immunomedics
The FDA suspended a clinical trial of Immunomedics' drug
candidate for pancreatic cancer after one patient was given a
higher-than-recommended dose. Immunomedics said the patient
"remains on study with no critical toxicity."
Ruling protects Baxter from claims tied to
Teva's IV drug propofol
A Delaware judge upheld an arbitration panel's finding that
Teva Pharmaceutical Industries is obligated to indemnify Baxter
International for any legal action concerning IV sedative propofol.
As of July, there were 300 lawsuits alleging that reused vials of
propofol caused a 2008 hepatitis C outbreak in southern Nevada.
Baxter marketed Teva's product until 2009.
Roche ends patent rift with Mylan
regarding cancer drug Xelota
Roche Holding and Mylan entered a licensing agreement to resolve
patent litigation involving the former's cancer drug Xelota.
Roche sued Mylan in 2009 for attempting to launch a generic version
before patent expiration. The settlement is subject to review by
the Federal Trade Commission and the Justice Department.
Report promotes generic-drug use to boost
health care savings
Generic medicines accounted for $931 billion in health care savings
over the past 10 years, according to a report prepared by IMS
Health for the Generic Pharmaceutical Association. The report
outlines four policy goals to achieve greater savings through
generics use, including pursuing an approval pathway for
biosimilars and eliminating restrictions on patent settlements.
Servier founder is under French scrutiny
for Mediator-related deaths
France is investigating Les Laboratoires Servier founder and
President Jacques Servier on suspicion that the company and its
five units engaged in fraudulent practices related to diabetes
treatment Mediator. The drug, withdrawn from the French market in
November 2009, was associated with almost 2,000 deaths. Servier
must post bail of about $5.4 million plus a guarantee of about $8.1
million before Dec. 15.
VA ceases ophthalmic use of Avastin amid
infection reports
The Veterans Affairs Department stopped using Roche Holding's
Avastin to treat patients with wet age-related macular
degeneration, as officials investigate reports of increased
infection risk. Avastin, a cancer drug, is prescribed by some
clinicians as a low-cost alternative to Lucentis, also by Roche.
"Once the investigation is complete, VA will reassess how
Avastin and similar therapies may be made available for
ophthalmologic use and will issue further guidance," the
department said.
FDA tentatively OKs Matrix's 3-drug
package of generic HIV therapy
Matrix Laboratories' co-package of three anti-retroviral
medicines was tentatively approved by the FDA, under the
President's Emergency Plan for AIDS Relief. The drugs are
generic versions of Gilead Sciences' Viread, Boehringer
Ingelheim's Viramune and GlaxoSmithKline's Epivir.
Lupin gains FDA approval for generic of
contraceptive Nor-QD
The FDA granted Lupin marketing approval for a generic version of
Watson Pharmaceuticals' oral contraceptive Nor-QD. The generic,
norethindrone, is Lupin's first birth control pill. Lupin will
launch its product "shortly."
FTC seeks more info on 2 proposed
takeovers by Valeant
The Federal Trade Commission wants additional information about
Valeant Pharmaceuticals International's proposed takeover of
the dermatology units of Sanofi and Janssen Pharmaceuticals. Both
transactions are still expected to be finalized by year-end,
Valeant said.
EU approves Vertex's hepatitis C drug
Incivo
Vertex Pharmaceuticals partner Janssen Pharmaceutica received EU
approval to commercialize Incivo, a hepatitis C medicine intended
to be taken with ribavirin and pegylated interferon. Vertex markets
the drug in the U.S. as Incivek.
FDA awards $6.5 million grant to school
for food inspectors
The Michigan-based International Food Protection Training Institute
has secured a five-year $6.5 million grant from the FDA to help it
establish a network of training instructors as part of the
implementation of the food safety law. "The training being
done at IFPTI is preparing thousands of food safety professionals
who are on the front lines protecting our food supply and keeping
our families safe," said Sen. Debbie Stabenow, D-Mich.
Pharma opposes Obama's deficit-cutting
proposal
Drugmakers criticized health care provisions in President Barack
Obama's $3.6 trillion deficit-reduction plan. The cuts would
increase unemployment and limit patient access to the latest
therapies, said the Pharmaceutical Research and Manufacturers of
America. Matt Bennett, PhRMA's senior vice president, opposed
the proposal's intent to strengthen the Independent Payment
Advisory Board, saying it could hurt Medicare beneficiaries.
FDA issues new guidance on unapproved
drugs
Companies marketing unapproved drugs that change a formulation to
evade attention are high on the FDA's list for enforcement,
according to this article. The agency has issued a revised guidance on unapproved drugs.
"All unapproved drugs introduced onto the market after [Sept.
19, 2011] are subject to immediate enforcement action at any time,
without prior notice." the FDA said.
FDA expands approval of Amgen's bone
drug Prolia
The FDA approved Amgen's Prolia to prevent bone fractures in
patients with breast or prostate cancer who are undergoing certain
hormone therapies. Prolia was originally indicated for
postmenopausal women at high risk of osteoporotic fracture.
Sanofi obtains favorable ruling on
Eloxatin patent
A federal court upheld Sanofi's market exclusivity for
Eloxatin, a drug for colon cancer. The ruling prevents Sun
Pharmaceutical Industries and other generic-drug makers from
launching their versions through August.
Watson partner Amphastar gets FDA OK for
generic Lovenox
Watson Pharmaceuticals said partner Amphastar Pharmaceuticals
secured FDA approval for a generic version of Sanofi's
injectable anti-clotting drug Lovenox, or enoxaparin. Momenta
Pharmaceuticals and Novartis unit Sandoz exclusively co-marketed
enoxaparin during the past year. Teva Pharmaceutical Industries is
awaiting an FDA decision on its generic Lovenox.
Appeal filed in ruling on stem cell
funding
Two scientists challenging federal funding for studies involving
human embryonic stem cells filed an appeal against a July ruling by
a U.S. district judge that dismissed their lawsuit. The scientists
claim that such research channels funding away from adult stem cell
studies, such as theirs.
Obama proposes shorter market exclusivity
for branded biologics
President Barack Obama's deficit-reduction plan includes a
proposal to shorten market exclusivity for biologic drugs from 12
years to seven, allowing competitors to introduce potentially
cheaper biosimilar versions earlier.
Food safety: Home kitchens may be riskier
than restaurants
Restaurants sometimes get blamed for foodborne illnesses that
originate much closer to home; public-health officials say most
food-poisoning cases happen in our own kitchens. The Centers for
Disease Control and Prevention offers food safety tips for home
cooks looking to emulate the safety of restaurant kitchens as they
deal with newer, more dangerous pathogens in the food supply.
Chip would screen toxicity of drug
candidates
The NIH and the Defense Advanced Research Projects Agency will each
invest as much as $70 million over five years on a chip to test
compounds for toxicity before they are administered to humans. The
agencies will also coordinate with the FDA, which could utilize the
chip to accelerate the drug-approval process. "If things are
going to fail, you want them to fail early," said NIH Director
Francis Collins. "Now you'll be able to find out much
quicker if something isn't going to work."
Food & Dietary Supplements
Senator asks FDA to craft standards for
imported juices
Sen. Charles Schumer, D-N.Y., has asked the FDA to develop
standards for imported juices and intensify inspections of such
products from China and other countries. Schumer said more
precautions are needed because children frequently drink fruit
juices. The lawmaker's call is in response to a statement last
week by Dr. Mehmet Oz on his show that some apple juice brands
contain high levels of arsenic. The FDA said it has been monitoring
arsenic concentrations in fruit juices.
BPA level in canned food is considered
safe, study finds
A Breast Cancer Fund survey of canned food at supermarkets found a
level of bisphenol A, or BPA, in food packaging well below the
amount considered safe by the government. "The BPA exposure
levels cited in this latest supermarket survey are very consistent
with similar, but much broader, surveys of packaged food conducted
within the past year by government agencies, including the FDA and
Health Canada," said John Rost, chairman of the North American
Metal Packaging Alliance.
Del Monte Fresh seeks to resolve conflict
with FDA over cantaloupes
Del Monte Fresh Produce said it is in discussions with the FDA to
resolve a dispute on import restrictions on cantaloupes and expects
to reach an agreement soon. In August, Del Monte Fresh filed a
lawsuit against the agency to lift an import alert issued on a farm
in Guatemala that is owned by the company and was suspected to be
the source of cantaloupes that have been found to be contaminated.
The alert was used by inspectors to block imports of melons grown
on the farm.
Bachmann calls for fewer food safety
laws
Food safety regulations are placing burdens on processors and
should be eased, said Republican presidential candidate Michele
Bachmann. The Minnesota congresswoman did not specify which rules
she would like repealed, but said safety must be balanced with
common sense. "When they make it complicated, they make it
expensive and so then you can no longer stay in business," she
said.
FDA says tainted cantaloupe caused
listeria outbreak
The FDA confirmed that a listeria outbreak that killed four people
and infected 35 in 10 states was caused by contaminated cantaloupe
grown at a Colorado farm. Jensen Farms recalled the cantaloupe
after health officials in Colorado discovered the problem.
Tobacco
Hearing on FDA's graphic tobacco
warnings begins
Government attorneys and lawyers representing tobacco makers
presented their arguments during a hearing on the companies'
request for a preliminary injunction against the FDA's
requirement of graphic warning labels on cigarette packs. "If
you tell people what they already know over and over again, in
flashy letters and big color pictures, it doesn't cause a
reduction in smoking," said Noel Francisco, a lawyer for R.J.
Reynolds Tobacco. "The government's interest here is not
in preventing habits, it's in preventing death," said Mark
Stern of the Department of Justice.
Report: New York spends little on
anti-smoking programs
A report by the American Cancer Society revealed that only 4% of
$10 billion in tobacco taxes collected by New York state in the
past six years went to anti-smoking campaigns. The report also
showed that the state government's annual spending on tobacco
control initiatives declined from $85.5 million in 2007 to about
$27 million this year. "The money collected in New York goes
up in smoke," said Blair Horner, co-author of the study.
"Very little of it gets spent on anti-smoking
programs."
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