CONTENTS:
BioControl to name epilepsy treatment spinoff as
Cerebral Rx
BioControl Medical said it plans to retain its business that
specializes in developing heart attack treatments, but will spin
off its epilepsy treatment unit into a new firm, Cerebral RX.
BioControl said its CardioFit system, which can treat symptoms of
heart failure by electrically stimulating the vagus nerve, also
holds promise for treating epilepsy.
Study raises questions on CRT device treatment
guidelines
A U.S. study published in the Archives of Internal Medicine found
that 38% of patients with a QRS duration between 120 to 150
milliseconds don't benefit from cardiac resynchronization
therapy devices even if they are considered candidates for such
devices as per treatment guidelines. The study also found that CRT
devices reduced by 60% the risk of death and adverse events in
patients with a QRS of 150 milliseconds or longer. Heart Rhythm
Society President Dr. Bruce Wilkoff cautioned drawing immediate
conclusions from the study, saying more in-depth research is needed
before guidelines should be modified.
FDA issues permanent injunction against 2
pharmaceutical firms
A permanent injunction filed by the FDA prohibits H&P
Industries and Triad Group from manufacturing pharmaceutical
products until the firms prove they comply with the agency's
safety standards. Two months ago, authorities confiscated products
worth more than $6 million at a Wisconsin facility. "This
action is necessary to ensure that the companies operate in full
compliance with federal quality standards and do not pose a risk to
patients," said FDA official Dara Corrigan.
Medical providers warned of Victoza's
serious risks by FDA
The FDA urged health care professionals to closely monitor patients
treated with injectable diabetes medicine liraglutide for symptoms
of acute pancreatitis or thyroid C-cell tumors. Novo Nordisk sells
the drug as Victoza.
Conditional approval given for anti-epileptic drug
Potiga
The FDA approved GlaxoSmithKline and Valeant Pharmaceuticals
International's Potiga, or ezogabine, as adjunctive therapy for
partial-onset seizures in patients older than 18. However, the
agency recommended that Potiga be considered a controlled
substance. "Final classification is still under review by the
federal Drug Enforcement Administration, and ezogabine will not be
available until this process is complete," the drugmakers
said.
Teva says Apotex's generic Azilect infringes
U.S. patents
Teva Pharmaceutical Industries filed a lawsuit claiming that
Apotex's proposed generic of Azilect infringes U.S. patents
that last through February 2017. The drug is indicated for
Parkinson's disease. Last year, Teva sued Watson
Pharmaceuticals and Orchid Chemicals & Pharmaceuticals for the
same issue.
FTC's "second request" delays
Teva-Cephalon merger
The Federal Trade Commission is seeking more information about Teva
Pharmaceutical Industries' proposed $6.8 billion takeover of
Cephalon. The agency's "second request" delays
antitrust clearance for 30 days. The firms remain optimistic that
the acquisition will be completed next quarter.
Study backs use of hA1c in diagnosis, management of
diabetes
The hemoglobin A1c test can be used to help diagnose and manage
diabetes, according to the evidence-based guidelines approved by
the American Diabetes Association published in the journal Diabetes
Care. The hA1c test helps measure venous plasma glucose and
monitors glycemic index, while alternative tests including
urine-albumine and genetic testing show minimal clinical
significance, experts said.
Experts produce laser light using bioengineered
cells
U.S. scientists were able to produce unidirectional laser light
after they genetically engineered cells derived from human kidneys
to generate green fluorescent proteins. The technique, published in
the journal Nature Photonics, may someday be used to improve
microscopic imaging.
Konica Minolta gets FDA clearance for tabletop CR
reader
The FDA has granted 510(k) clearance to Konica Minolta Medical
Imaging for its Regius Sigma tabletop CR reader, which is designed
for use in low-volume clinics.
Accuray completes $277 million purchase of
TomoTherapy
Accuray has completed its acquisition of TomoTherapy, a maker of
radiation treatment devices for cancer, for $277 million. Under the
deal, Accuray will incorporate TomoTherapy into its Jaguar
Acquisition unit.
PerkinElmer expands medical imaging portfolio with
Dexela purchase
PerkinElmer has bought Dexela, a London-based firm that provides
X-ray detection systems and related services, for an undisclosed
amount. PerkinElmer said its purchase of Dexela would allow it to
broaden its pipeline of medical imaging systems in surgery,
cardiology and mammography, among other areas.
J&J orthopedic unit names industry veteran as
president
DePuy Orthopedics, a Johnson & Johnson unit, has appointed
industry veteran Andrew Ekdahl as its president. Ekdahl succeeds
David Floyd, who left his post in March.
AngioDynamics announces resignation of
CEO
AngioDynamics said President and CEO Jan Keltjens has resigned,
effective immediately, and will leave his post as a member of the
firm's board of directors. Scott Solano, AngioDynamics'
chief technology officer, will take over as acting CEO.
Physicist to get MIT prize for biointegrated
electronics
John Rogers, a physicist and materials scientist at the University
of Illinois, is slated to receive the $500,000 Lemelson-MIT Prize
for his research into biointegrated electronics, among other
technology areas. One of Rogers' inventions is a biointegrated
electronics catheter that can monitor and zap faulty heart
tissue.
Immucor announces CEO resignation, names new chief
exec
Immucor President and Chief Executive Gioacchino De Chirico is
resigning but will stay on during the transition period, the
company announced. Joshua H. Levine, Mentor's former president
and CEO, will immediately assume De Chirico's
responsibilities.
Thoratec CFO leaves post
Thoratec Chief Financial Officer David Smith, who has been with the
company since December 2006, has resigned from his post, effective
June 10. Roxanne Oulma, the device firm's vice president of
finance, will serve as acting CFO.
Siemens gets FDA approval for Biograph mMR
system
Siemens has received FDA approval for its Biograph mMR system,
which allows for simultaneous scanning using positron emission
tomography and MRI. "Minimizing changes in a patient's
position between tests allows physicians to compare images more
easily and helps them get the most accurate information
possible," said Alberto Gutierrez of the FDA's Center for
Devices and Radiological Health. The device was cleared by European
regulators earlier this month.
FDA releases draft guidance for
nanotechnology
The FDA has released draft guidelines for the regulation and
supervision of nanotechnology. Products for premarket review will
be evaluated using the criteria presented in the draft guidelines,
the FDA said.
Tengion gets orphan-drug status for
urinary-diversion tool
The FDA has granted an orphan-drug status to Tengion for its
Neo-Urinary Conduit, a technology that can produce functional
tissues that can be used to divert the flow of urine into an
external, disposable bag. The system, which is designed for
patients who have had a bladder removal surgery due to bladder
cancer, is being tested in an early-stage clinical trial.
NanoLogix CEO expects FDA to clear diagnostic
tests for bacteria
NanoLogix CEO Bret Barnhizer said the Ohio-based company expects to
secure in the next few months FDA clearances for several diagnostic
tests, which can rapidly detect a wide range of bacteria. One of
the company's products is BioNanoPore technology, which is
being tested in two clinical trials to determine its ability to
spot Group B Streptococcus.
Task force presents recommendations for reading
hybrid images
A task force of SNM and American College of Radiology members has
drawn up six recommendations for improving the way physicians,
radiologists and nuclear medicine specialists read cross-modality
images. The six recommendations, published in the Journal of
Nuclear Medicine, highlight the need for more training in anatomic
and functional imaging.
Wisconsin patient files lawsuit against device
firm, hospital
A male patient in Wisconsin has sued Medtronic claiming that he
suffered partial facial paralysis after the firm's nerve
monitoring device failed to work during a tumor removal surgery.
The patient also said that the hospital and surgeon failed to
notify him of the risks linked to the surgery. The patient is
seeking $300,000 in damages.
GE Healthcare gets FDA clearance for visualization
software
The FDA has cleared GE Healthcare's AngioViz visualization
software, which can project vascular flow images as observed in the
Digital Subtraction Angiography imaging.
Lilly forms orthopedic partnership with
Synthes
Eli Lilly and Co. and Synthes agreed to jointly develop and
commercialize therapies for orthopedic conditions. The companies
also will co-promote Lilly's osteoporosis medicine Forteo
domestically and explore additional indications for the drug.
Synthes, a medical-device maker, has rights to Lilly's
early-stage pipeline of bone treatments.
CAS Medical attracts $15 million investment for
blood monitors
CAS Medical Systems has secured an investment worth $15 million
from Thomas, McNerney & Partners. The company will use $13.7
million to support the development of its Fore-Sight tissue
oximeters and other monitoring hardware, said Thomas M. Patton, CAS
Medical's president and CEO.
Source BioScience collaborates to develop genetic
test for cancer
Source BioScience has partnered with Illumina and London-based
Barts Cancer Institute to develop a genetic diagnostic test that
could be used in classifying different types of tumors and
tailoring treatments to patients. Illumina will use its DNA
sequencing tool to profile specimens from Barts' tissue bank
that will be used by Source BioScience as a basis for the
development of the test.
Access Scientific pulls in $10 million in equity
financing
Access Scientific has secured $10 million in a round of equity
financing led by CAC, a private equity firm. The San Diego-based
company specializes in developing IV catheters, including the
FDA-cleared Power Wand device.
Health Canada gets "unsatisfactory" mark
on device regulation
The Office of the Auditor General of Canada gave Health Canada an
"unsatisfactory" mark for failing to properly address
problems cited in two previous audits and assess how much effort it
needs to exert on surveillance and inspections in order to ensure
the safety and efficacy of medical devices. "According to
Health Canada, this problem is due to a funding shortfall caused by
rapid growth in medical device technology and increasingly complex
submissions," according to the audit.
Eucomed wants same classification for
blood-processing devices
Eucomed, a device trade group in Europe, has released a document
supporting the current classification of devices used for
collecting and storing blood components and provided information on
a new connector design aimed at preventing the risk of faulty
connections in such devices. The position paper comes as regulatory
bodies consider revising the classification of blood-processing
products.
Senators want inquiry into physician-owned
distributorships
The inspector general of HHS has been asked by a bipartisan group
of five U.S. senators to conduct an inquiry into physician-owned
distributorships, which serve as intermediaries between hospitals
and medical device firms, to determine if they violate
anti-kickback laws and other regulations. A Senate report says
surgeons investing in PODs can get a commission for the sale of
devices to hospitals. The senators have set an Aug. 12 deadline for
the inspector general's preliminary report on the
investigation.
Army test for parasitic disease wins FDA
clearance
The SMART Leish PCR assay, which uses polymerase chain reaction to
help detect cutaneous leishmaniasis, has received FDA clearance.
Among the developers of the qualitative test are Cepheid USA and
the Army Medical Research and Materiel Command.
Study: More inappropriate SPECT MPI tests
conducted in women
A study published in the Journal of Nuclear Cardiology found that
68% of inappropriate SPECT MPI studies and 82% of uncertain studies
were conducted in women. The researchers employed appropriate use
criteria to review 314 MPI studies conducted by cardiologists and
primary care physicians to determine whether gender disparities can
be seen in such tests. The study "indicates a continuing need
for education among PCPs for appropriate test ordering,
particularly for women," the U.S.-based researchers said.
Miramar Labs pulls in $35.8 million in
financing
Miramar Labs has secured $35.8 million in a round of Series C
financing. The California-based firm will use the money to bring to
market its miraDry, a laser-based device that was cleared by the
FDA to treat excessive underarm sweat.
AxoGen merges with LecTec
AxoGen has merged with LecTec, a health care investment firm, in a
deal that will allow AxoGen to operate as a wholly owned unit of
LecTec. AxoGen said the merger will enable it to bolster the sales
of its nerve repair products, including Avance nerve graft and
AxoGuard nerve protector.
Advanced Cardiac's ablation catheter gets
approval in Europe
Advanced Cardiac Therapeutics has been given CE Mark approval for
its Tempasure cardiac ablation catheter for use in the treatment of
atrial fibrillation and other forms of arrhythmias. The company
plans to introduce the device, which is equipped with a
temperature-sensing technology, later this year.
Teleflex Medical to bring 80 jobs to
Ireland
Teleflex Medical, which makes catheter and tubing devices,
announced plans to generate 80 jobs in Limerick, Ireland, as part
of its expansion.
NICE issues draft approval for Allergan's
implant for macular edema
The U.K. National Institute for Health and Clinical Excellence has
recommended the use of Ozurdex, Allergan's drug-eluting
intravitreal implant, for the treatment of macular edema after
central retinal vein occlusion and, in some cases, branch retinal
vein occlusion. NICE is expected to release its final guidance on
the product in July.
Study: PET/CT better than SPECT in diagnosing
pediatric sarcoma
PET/CT showed 100% sensitivity, specificity and accuracy in
diagnosing pediatric sarcoma, thus performing better than SPECT
bone scans in diagnosing the disease, according to a study
presented at the SNM annual meeting in San Antonio, Texas.
"The results of this study strongly suggest that pediatric
sarcoma patients who undergo PET/CT do not benefit from an
additional Tc-99m MDP bone scan," said lead study author Dr.
Franziska Walter, of the University of California, Los
Angeles.
Experts develop new artificial pancreas for
patients with type 1 diabetes
A closed-loop artificial pancreas system is being developed to help
lessen the demands of blood glucose monitoring in patients with
type 1 diabetes, according to researchers at the Rensselaer
Polytechnic Institute. Experts said the new artificial pancreas
will be combined with a blood sugar monitor that will test the
patient's glucose levels while simultaneously adjusting the
amount of insulin delivered to the body.
FDA warns Compass International over stereotactic
systems
Compass International Innovations, a maker of stereotactic position
devices, is the subject of a warning letter from the FDA saying the
company failed to set up procedures for validating software used in
its surgical systems, among other violations. Compass President Jon
Rousu was not available for comment.
Venture capitalists seek clearer regulatory
pathway for devices
Venture capitalists in the medical device industry are asking the
U.S. government to create a clearer regulatory pathway for medical
technologies as more companies prefer going abroad to seek approval
and market their products, said Mike Carusi, a member of the
Medical Device Venture Council. In this interview with The Wall
Street Journal, Carusi said investors who went to Washington, D.C.,
to air their concerns to Senate panels want the federal government
to "seek external expertise, and be better
informed."
Consulting an attorney can help doctors protect
invention rights
Physician inventors seeking to protect their intellectual property
for a medical device should ask a witness to sign and date the
information about an invention on a lab book and ask an attorney
specializing in intellectual property law to provide preliminary
recommendations, among other measures. "At the end of the day,
if you take basic steps in protecting your idea and understand that
providing clinical expertise does not make you an inventor, you
will avoid most conflicts and feelings of mistreatment,"
according to this article.
FDA panel schedules review for Edwards
Lifesciences' cardiac valve
An FDA panel is set to meet July 20 to evaluate Edwards
Lifesciences' Sapien transcatheter aortic valve, which can be
implanted without the need for open-heart surgery, the company
said. "Given the high mortality benefit seen in Partner Cohort
B, we expect a positive panel recommendation and ultimately FDA
approval of Sapien," said Larry Biegelsen, a Wells Fargo
Securities analyst.
Ximedica opens third office in
Minneapolis
Ximedica has opened an office in Minneapolis that will house
employees involved in the firm's human factors, industrial
design and engineering operations. The company also plans to expand
its headquarters in Providence, R.I., to accommodate its growing
product development operations.
Torax Medical pulls in $4 million in debt
financing
Torax Medical said in a regulatory filing that it has secured $4
million in debt financing and is looking to raise an additional $4
million. The Minnesota-based company already has filed a premarket
approval application with the FDA for its Linx Anti-Reflux device,
which currently is marketed in Europe.
Philips recalls infant- and neonatal-sized
ventilation devices
Philips Healthcare has voluntarily recalled certain lots of its
ventilation devices for infants after finding that plastic strands
from the device have the potential to dislodge and be inhaled by
patients, which could lead to serious illness or death. The company
said it already has informed users to get rid of the devices
affected by the recall and that it hasn't received any reports
of injuries associated with the problem.
FDA gives OK to Canadian company's celiac
tests
SQI Diagnostics' automated technology and assays for celiac
disease testing have been cleared for U.S. sales by the FDA, the
company said. The celiac tests already were approved in
Canada.
Carclo sets up diagnostic firm to license
point-of-care testing platform
U.K.-based Carclo has set up Carclo Diagnostic Solutions in order
to secure licensing deals for microPOC, a disposable electronic
testing technology. The new company already has signed a
partnership deal with EKF Diagnostics, which intends to bring to
market its kidney markers through the microPOC format.
St. Jude Medical launches clinical trial of heart
valve in Canada
St. Jude Medical has started a clinical trial in Canada to measure
the safety and efficacy of Portico, its transcatheter heart valve
made of bovine pericardial tissue, in patients with severe aortic
stenosis. The company also plans to conduct a European clinical
study of the device later this year.
Breast density bill makes headway in 2
states
A bill in Texas that would require women be educated on the density
of their breast tissue has passed the House of Representatives and
is awaiting Gov. Rick Perry's signature. A similar measure in
California has passed the Senate and is set to be reviewed by the
Assembly. The bill would mandate that women be informed of their
breast density, as well as the methods in additional mammogram that
they may seek to use for disease screening.
Regeneron and Bayer seek European OK for VEGF
Trap-Eye
Bayer and Regeneron Pharmaceuticals filed a marketing application
in Europe for VEGF Trap-Eye, or aflibercept, to treat patients with
wet age-related macular degeneration. VEGF Trap-Eye, undergoing
priority review in the U.S., is also being developed for diabetic
macular edema, central retinal vein occlusion and myopic choroidal
neovascularization.
EU regulators OK Biogen's injectable pen for
Avonex
European regulators have given Biogen Idec approval to market an
injectable pen used for administering Avonex, a multiple sclerosis
drug. The pen is equipped with a protective guard and a safety lock
designed to prevent injection mistakes, among other
features.
Bolivia proposes expansion of biotech crop
adoption
The administration of Bolivian President Evo Morales has proposed a
bill in Congress that would expand the adoption of biotech crops in
the country in an attempt to boost food production, said Cabinet
Minister Carlos Romero. However, a government panel needs to
conduct health and environmental impact assessments prior to the
crops' adoption.
GE Healthcare secures FDA clearance for SPECT
scanner
GE Healthcare announced it has obtained FDA clearance for its
Discovery NM630 SPECT scanner, which it said can be modified
on-site to function as a SPECT/CT system. The company said during
the SNM annual meeting that the system is designed to handle
heavyweight patients and can reduce radiation exposure by as much
as 50%. The company also launched its Optima PET/CT 560 scanner,
which offers skin and bone imaging.
Increase in doctors' complaints adds to
scrutiny of drug promotion
The FDA has received 328 complaints since last year's launch of
the Bad Ad Program, which encourages health care professionals to
report misleading drug marketing. "The program has been
immensely successful," said FDA official Thomas Abrams.
"I'm very pleased to see such an overwhelmingly positive
response from the health care community."
U.S. investigates Gilead's drug manufacturing
and distribution
The Justice Department subpoenaed Gilead Sciences for information
related to production and distribution of several products,
including HIV drug Atripla and lung medicine Letairis. Gilead said
it is cooperating with the investigation.
Merck redesigns drug labels to prevent dispensing
error
The FDA cleared revised labels for diabetes medicine Januvia,
allergy drug Singulair and 14 other oral treatments from Merck
& Co. The drugmaker used a standardized format to improve
readability and dosage differentiation. "This was no small
undertaking, and we are hopeful that Merck's new standardized
labels will aid in reducing pharmacy selection errors," said
FDA official Janet Woodcock.
Novo agrees to resolve marketing claims for $26.7
million
Novo Nordisk's U.S. subsidiary will pay $25 million to end a
federal investigation and civil litigation regarding off-label
promotion of bleeding-disorder drug NovoSeven. The unit will also
pay $1.73 million to settle claims that sales representatives
sought confidential patient data and submitted false reports to
Medicaid concerning diabetes medicines Novolog and Novolin.
FDA allows clinical testing of Ziopharm drug for
melanoma
The FDA approved Ziopharm Oncology's request to begin a Phase I
trial of ZIN ATI-001, a drug candidate for melanoma. The product is
the second cancer compound developed as part of Ziopharm's
collaboration with Intrexon.
FDA approves Aurobindo's generic of heart
medicine Altace
The FDA authorized Aurobindo Pharma to manufacture and sell
ramipril, a generic version of King Pharmaceuticals' heart drug
Altace. The approval covers 1.25-, 2.5-, 5- and 10-milligram
capsules.
Bristol addresses manufacturing violations at
Puerto Rican facility
The FDA said Bristol-Myers Squibb sufficiently corrected
manufacturing deficiencies at a Manati, Puerto Rico, facility.
Bristol's corrective action clears the way for the FDA to
approve kidney-transplant drug belatacept and a formulation of
rheumatoid arthritis medicine Orencia, both to be made at the
plant.
Germany and France pull Takeda's diabetes pill
Actos from market
French and German regulators are banning Takeda
Pharmaceutical's diabetes medicine Actos in light of an
epidemiological study linking the drug, also known as pioglitazone,
to an increased risk of bladder cancer. U.S. officials did not
indicate a plan to follow suit, Takeda said.
FDA warns of serious cancer risk in some prostate
drugs
The FDA said it strengthened the warning label of 5-alpha reductase
inhibitors, a class of medicines designed to treat enlarged
prostate, after a review of two large studies indicated that men
taking the treatment are more likely to develop high-grade prostate
cancer. "This risk appears to be low, but health care
professionals should be aware of this safety information, and weigh
the known benefits against the potential risks when deciding to
start or continue treatment with 5-ARIs in men," according to
the agency's website.
UCB unit is penalized for off-label marketing of
Keppra
A U.S. subsidiary of UCB pleaded guilty to a misdemeanor charge
regarding the promotion of anti-epileptic medicine Keppra for
unapproved use, according to the Justice Department. The company
will pay about $34 million in asset forfeiture and criminal and
civil fines, the department said.
Sources: FTC looks to bypass courts and Congress
on pay-for-delay
The Federal Trade Commission reportedly is considering exercising
its rule-making authority to restrict deals that delay a generic
drug's market entry. Such agreements are made between makers of
brand-name drugs and generic-drug makers. "There are few
competitive problems that harm consumers as much as the
pay-for-delay settlements," said attorney David Balto, who
represents consumer groups on this issue. "This is an endemic
problem that needs a comprehensive solution."
Updated label for Lilly's insulin Humalog is
approved by FDA
The FDA approved an updated label of Eli Lilly and Co.'s
insulin Humalog that includes notice for children's use. The
company also said that for patients with type 1 diabetes who use an
insulin pump, the pump reservoir and insertion site should be
changed every three days, instead of two.
FDA limits use of high-dose Zocor because of
myopathy risk
The FDA recommended that 80 milligrams of Merck & Co.'s
cholesterol-lowering drug Zocor, or simvastatin, no longer be given
to patients unless they have taken the medicine for more than a
year without muscle pain. Data from a seven-year study confirm that
80-milligram Zocor poses a greater risk of myopathy than a lower
dose or other statins, the agency said. The FDA also issued a
safety alert for simvastatin-containing medicines Vytorin and
Simcor.
Court sides with Lilly in diabetes dispute with
Amylin
A federal court in Southern California lifted a restraining order
that prohibited Eli Lilly and Co. from designating the same
marketing personnel to Amylin Pharmaceuticals' Byetta and
Boehringer Ingelheim's Bydureon, which are injectable
treatments for diabetes. The court also declined to grant Amylin a
preliminary injunction. "We have complied with our contractual
obligations under our agreements with Amylin, and done so in a
manner fully consistent with all applicable laws," said Robert
Armitage, Lilly's general counsel.
Watson's generic of contraceptive Lybrel gets
FDA OK
Watson Laboratories received FDA approval to launch a generic
version of Lybrel, Pfizer's birth control pill. The
contraceptive contains 0.09 milligram of levonorgestrel and 0.02
milligram of ethinyl estradiol.
FDA grants Aurobindo marketing approval for
generic Xanax XR
The FDA is allowing Aurobindo Pharma to produce and sell multiple
doses of extended-release alprazolam, a treatment for panic
disorder. The product is a generic version of Pfizer's Xanax
XR.
Edison secures orphan-drug status for
genetic-disorder therapy
The FDA gave Edison Pharmaceuticals' EPI-743 orphan-drug
designation as a treatment for inherited respiratory chain
disorders of the mitochondria.
FDA's decision on Lannett morphine is expected
by June 23
The FDA is scheduled to decide by June 23 whether to allow the
relaunch of Lannett's morphine sulfate oral solution, a generic
painkiller. Last year, Lannett was forced to halt sales because of
a crackdown on products launched before the FDA implemented
regulatory requirements.
Incyte asks FDA to accelerate review of blood
cancer drug
Incyte said it is seeking FDA priority evaluation of ruxolitinib, a
drug candidate for myelofibrosis. Partner Novartis plans to submit
ruxolitinib this month for EU review.
House bill on FDA action would harm consumers,
agency says
An amendment approved by the House Appropriations Committee would
require the FDA to wait until people are harmed by unsafe drugs or
food before taking action, the agency said. "FDA must
sometimes act when there are credible risks, but before the weight
of scientific evidence has been established," the agency said
in documents on the amendment.
Advocates push Congress and NIH to boost
orphan-drug development
Since the Orphan Drug Act was signed in 1983, 2,400 drugs have
received orphan designation and 367 have been approved. The
National Organization for Rare Disorders and other advocates are
encouraging Congress to pass or renew legislation that would boost
orphan-drug development. Meanwhile, President Barack Obama's
proposed budget for fiscal 2012 would create an NIH institute for
translational medicine that would centralize research.
USDA kicks off plans to curb salmonella
infection
The USDA last month made several changes to its recommendations for
safely cooking meat, including pork and steak, in an effort to
prevent salmonella poisoning and other food-borne infections. The
agency also is set to unveil this summer a national multimedia
campaign designed to promote safe food preparation.
Prevalence of pesticide residue puts apples atop
"Dirty Dozen"
The Environmental Working Group has ranked apples No. 1 in its
"Dirty Dozen" list, which is set to be released today,
after the USDA found pesticide residues in 98% of apple samples.
The consumer advocacy group, however, didn't advise consumers
to avoid the foods in its list because the "health benefits of
a diet rich in fruits and vegetables outweigh the risks of
pesticide exposure," said Sonya Lunder, an analyst for the
group.
FDA deserves credit for enforcing dietary
supplement policies
The FDA deserves to be applauded for issuing warning letters and
initiating recalls, among other actions, that show it is increasing
its attention to dietary supplements, writes Stephen Daniells.
"It is also pleasing to see responsible companies reacting
quickly to potential issues," Daniells writes.
U.S. Commerce Department agency unveils
aquaculture policies
The National Oceanic and Atmospheric Administration has introduced
policies that would promote the aquaculture industry in the U.S. by
setting up a National Shellfish Initiative, among other plans. Only
a small portion of aquaculture imports to the U.S. are inspected. A
NOAA official said the policies will promote a sustainable source
of seafood, but one consumer group said the plans open the Gulf of
Mexico to "factory fish farms."
FDA says some chickens may contain arsenic from
feed ingredient
The FDA said that in its study of 100 chickens, those that ate feed
with an ingredient called Roxarsone showed higher levels of
inorganic arsenic in their livers compared with chickens that were
not given the feed ingredient. The FDA, however, said that the
arsenic amount is too small to harm people who consume the affected
chickens. Pfizer, which makes the feed ingredient, said it will
pull it from the U.S. market.
Senator seeks to intensify screening of meat
supply for E. coli
Sen. Kirsten Gillibrand, D-N.Y., has proposed a bill that would
require meat production facilities to test their products for
high-risk pathogens and E. coli strains in an effort to curb
food-borne illnesses. Gillibrand also has asked the USDA to
classify additional E. coli strains as contaminants.
Salmonella cases are up despite drops in other
foodborne infections
The CDC's FoodNet system reported a 50% drop in E. coli O157
cases in the past 15 years and a 23% drop in infections from six
other foodborne illnesses in 2010, but it also found that
salmonella infections rose by 10%. According to the report, nine
foodborne infections resulted in about 20,000 reported illnesses,
4,200 reported hospitalizations and 68 reported deaths in
2010.
EU farm chief raises aid offer and FDA consults
with Germany
Dacian Ciolos, the European Union's farm commissioner, has
proposed compensation worth $306 million to European vegetable
farmers who are incurring losses as a result of the E. coli
outbreak. The offer of financial aid, which would cover losses
through the end of this month, was increased from $219 million
after the governments of Spain, Italy and France demanded more
help. Meanwhile, CDC Director Thomas Frieden said the agency has
offered its help in Europe and has had "informal discussions
and consultations" with German authorities about the
outbreak.
Audit: Virginia spends tobacco money on
unproductive projects
Virginia's Tobacco Indemnification and Community Revitalization
Commission invested too much money from a tobacco settlement on
projects that failed to create jobs, according to an audit. Del.
Terry G. Kilgore, R-Scott, the commission's chairman, said the
commission has begun addressing the issues raised in the
report.
Ex-FDA official to oversee Lorillard's
compliance with tobacco law
Lorillard has appointed Neil Wilcox, a former science policy
analyst at the FDA, as its senior vice president and chief
compliance officer. Wilcox will help Lorillard comply with the
Family Smoking Prevention and Tobacco Control Act, among his other
duties, the company said.
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