Food industry stakeholders were closely watching for details on the president's request for FDA because the agency, which oversees 80 percent of the food supply, is rolling out the one-year-old Food Safety Modernization Act, an initiative the Congressional Budget Office estimates will cost $1.4 billion over five years to implement.
For FY 2012, the FDA ended up receiving a $50 million boost, in large part to help fund food safety -- a somewhat miraculous feat in a tough budgetary environment. Under the Obama budget plan, FDA's discretionary budget would be essentially frozen at current levels for FY 2013, at $2.5 billion.
The plan calls for a $253 million increase for food safety, $220 million of which would come from industry fees. The request also seeks $10 million to improve FDA's cooperation with and capacity in China.
"The end result is that agencies like the FDA are more and more dependent on user fees raised by some of the same industries they oversee,"
Politico noted Friday. Forty-four percent of Obama's $4.5 billion request for FDA comes from various fees.
It is not clear what types of food facilities would pay fees, or whether the fees would extend to farms. The details have not yet been worked out, according to Patrick McGarey, Assistant Commissioner for Budget at FDA.
"This is a situation where we've characterized this as a food safety registration fee. The law defines who should register...that's a proposal that they're familiar with from years past," said McGarey, referring to the House version of the Food Safety Modernization Act, which did not become law.
"We're open to working with industry to shape a proposal that meets their objectives and our objectives and meets the public health needs of food safety," added McGarey. "We've not defined the registration fee yet as to which facility and at what amount the fee would be assessed."
"We're just open to alternative recommendations. If we're open minded about it, we get some constructive and creative proposals," he said. "We're eager to get comments and feedback from stakeholders."
What is clear is that a broad coalition of food industry groups
are vehemently opposed to food safety fees.
"Imposing new user fees on food makers is the wrong option for supporting food safety programs as businesses can ill afford new cost burdens, which ultimately would represent a new food safety tax on consumers," read an industry letter sent to the so-called supercommittee in October.
The Alliance for a Stronger FDA, a coalition of industry and consumer groups, reacted to the proposal with concern because it relies too heavily on fees.
"The FDA's essential role in protecting public health continues to grow to meet the demands of our time. With no other agency as fallback, we believe that FDA's funding should be increased to reflect the agency's vast responsibilities and increased workload," said Margaret Anderson, president of the Alliance and executive director of FasterCures. "Inadequate funding for the FDA has real and immediate consequences as it jeopardizes the public health."
"In this year of austerity, we appreciate that the President has proposed the same funding for FDA, even while many other agencies have been cut. However, this is not enough when the FDA mission is expanding and the agency is providing services and protections that Americans value," said Diane Dorman, of the National Organization for Rare Disorders, who serves as vice president of the Alliance.
Iowa has reported five cases, Missouri three, Kansas two, while Arkansas and Wisconsin have each reported one person infected with the outbreak strain, the CDC said in an
investigation report Wednesday.
Those sickened range in age from 9 to 49 years old. Median age is 25. All the victims are female. Two of the 12 have been hospitalized.
The CDC says the onset of their illnesses ranged from Dec. 25, 2011 to Jan. 15, 2012.
"Preliminary results of the epidemiologic and traceback investigations indicate eating raw clover sprouts at Jimmy John's restaurants is the likely cause of this outbreak," the CDC concluded in its report.
Raw sprouts served on sandwiches at Jimmy John's restaurants have been associated with multiple foodborne illness outbreaks in recent years.
In 2008, at least 19 E. coli O157:H7 cases were linked to alfalfa sprouts sold at Colorado Jimmy John's restaurants. In 2009, 228 people became ill in Nebraska, Iowa, South Dakota and Kansas after eating Salmonella-contaminated sprouts at several restaurants, including Jimmy John's outlets.
In late 2010, a 16-state Salmonella outbreak that struck 94 people was linked, in part, to alfalfa and spicy sprouts served at Jimmy John's restaurants, while a separate outbreak of Salmonella a month later, which sickened seven people in Oregon and Washington, was also tied to Jimmy John's sandwiches.
Following those outbreaks, the company announced it was switching from alfalfa sprouts to clover sprouts nationwide.
In this latest outbreak, there's strong epidemiologic evidence tying the illnesses to the Jimmy John's chain.
Among 11 of the ill people who gave information to investigators, 10 -- or 91 percent -- reported eating at a Jimmy John's restaurant in the week before they became sick. Among those 10, eight said they ate a sandwich containing sprouts and 9 reported eating a sandwich containing lettuce.
The ill people ate at nine different Jimmy John's locations in four states, the CDC reported.
A traceback investigation by the Food and Drug Administration (FDA continues, but the CDC said preliminary evidence points to a common lot of clover seeds used to germinate the sprouts served at the Jimmy John's outlets where the sick people ate.
"FDA and states conducted a traceback that identified two separate sprouting facilities; both used the same lot of seed to grow clover sprouts served at these Jimmy John's restaurant locations," the report stated. "On February 10, 2012, the seed supplier initiated notification of sprouting facilities that received this lot of clover seed to stop using it. Investigations are ongoing to identify other locations that may have sold clover sprouts grown from this seed lot."
At this time, the CDC said no other restaurants or grocery stores are associated with the outbreak.
PulseNet, the national surveillance system of foodborne illnesses, is being used to identify additional cases that might be part of the outbreak.
But the E. coli serotype in this latest outbreak is rare, and the genetic fingerprint pattern has never been seen before in PulseNet, the CDC said. The 026 serotype is among the so-called "Big Six" E. coli strains soon to be regulated in ground beef.
The CDC notes that because non-O157 E. coli strains are more difficult to identify than E. coli O157:H7, many clinical laboratories do not test stool specimens for them and therefore O26 infections may go undiagnosed and unreported.
When Jimmy John's began serving raw clover sprouts a year ago, it did so saying it hoped to decrease the chances of contamination. Clover seeds are smoother than alfalfa seeds, and presumably easier to sanitize.
Sprouts, which have been the cause of many foodborne epidemics, are considered a high-risk food because they have the potential to carry large amounts of pathogens. If the seeds used to germinate sprouts become contaminated with feces from domestic or wild animals - perhaps through contaminated water or improperly composted manure fertilizer - the sprouts will also be contaminated. The warm, moist conditions used to grow sprouts permit harmful bacteria to rapidly multiply.
Citing food safety concerns, Walmart stopped carrying sprouts in its stores in October 2010. Last month, the national restaurant chain Jason's Deli announced it would not serve sprouts for the remainder of 2012 and possibly 2013. Since 2000, sprouts have been linked to 30 foodborne illness outbreaks in North America, Europe and Australia, including last spring's outbreak of E. coli O104:H4 centered in Germany, which sickened 4,321 people and killed more than 50. That outbreak has been linked to sprouts grown from contaminated fenugreek seeds.
The continued use of raw sprouts in the face of multiple outbreaks has many baffled, including food safety attorney Bill Marler, publisher of Food Safety News. "As a business man I am left wondering why a company would continue to take this kind of financial and public relations risk," Marler said in a news release. "As a food safety advocate I am concerned that customer safety is not being taken seriously."
"When people think of sprouts, they think of a health food. They aren't thinking about serious illness, hospitalization, or worse," he said. "However, the track record for sprouts suggests that consumers ought to know the dangers. And, of course the onus for providing this information falls on those who are selling sprouts."
Marler has suggested that sprout growers include a warning label on their product that alerts consumers to the risks associated with consuming raw sprouts.
CDC Outbreak Map:
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James Andrews contributed to this report.
AMERICA'S Food and Drug Administration (FDA
announced late on February 14th that 19 medical practices had bought counterfeit Avastin, a popular cancer drug. The doctors and hospitals bought the bum drug from a foreign supplier, Quality Specialty Products.
As such scares go, this one could have been worse. Avastin, marketed in America by
Genentech, is an injected drug available only in hospitals and doctors’ offices. Presumably health professionals will spot rogue bottles more quickly than the average consumer would have. So far there have been no reports of dangerous reactions, unlike some past incidents—in 2008 a sham bloodthinner made in China killed several Americans and sickened many more.
But the news is alarming nonetheless. It is another reminder of how vulnerable the drug supply-chain remains. About 80% of ingredients for drugs bought in America are made elsewhere. Imports of drugs have grown by nearly 13% a year. Regulators have
done their best to keep up. The FDA has opened a series of offices abroad; inspections of foreign factories increased by 27% from 2007 to 2009. It is trying to foster
collaboration with foreign regulators—apparently Britain’s Medicines and Healthcare Products Regulatory Agency alerted the FDA to the counterfeit Avastin. More changes are on the way. Generic drug companies have agreed to pay the FDA a fee to increase foreign inspections, a deal that must still be approved by Congress. The FDA is also
asking the government for more money to expand its operations in China. But change, as the recent fiasco proves, is not coming fast enough.
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February 14, 2012
Editors The Pulse of Natural Health. Thisnewsletter is copyrighted material (© 2012 by Alliance for Natural Health USA but we hope you will forward, copy, or reprint it without prior authorization.Just remember to note the source and date, and please link to original contenton the ANH-USA website. The information in The Pulse of Natural Health is for educational purposes only and should not be construed as medical advice. Readers are advised to consult a qualified professional about any issue regarding their health and well-being. |
Follow ANH-USA on ANH-USA Vice President Deborah Ray has been bringing quality health information to radio listeners since 1982 and has been consistently named among the top 100 most important talk radio hosts in America by |
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The Centers for Disease Control and Prevention is collaborating with public health officials in multiple states and the U.S. Food and Drug Administration (FDA to investigate a multistate outbreak of Shiga toxin-producing
Escherichia coli
serogroup O26 (STEC O26 infections likely linked with eating raw clover sprouts. Public health investigators are using DNA "fingerprints" of
E. coli
bacteria obtained through diagnostic testing with pulsed-field gel electrophoresis, or PFGE, to identify cases of illness that may be part of this outbreak. They are using data from
PulseNet, the national subtyping network made up of state and local public health laboratories and federal food regulatory laboratories that performs molecular surveillance of foodborne infections.
The full notice can be found at:
http://www.cdc.gov/ecoli/2012/O26-02-12/index.html
The health care products giant Johnson & Johnson continued to market an artificial hip in Europe and elsewhere overseas after the Food and Drug Administration rejected its sale in the United States based on a review of company safety studies.During that period, the company also continued to sell in this country a related model, which earlier went on the market using a regulatory loophole that did not require a similar safety review.
It is not known how many people overseas received the replacement hip after the agency decided in 2009 not to approve it, nor the number who received the closely linked implant sold in this country. During some eight years on the market, the two implants were used in about 93,000 patients worldwide, about one-third of them in the United States. Both models were based on the same component, an all-metal hip socket cup that experts say was faulty in design.
The DePuy orthopedic division of Johnson & Johnson, citing declining sales, began phasing out both models of the device — formally known as an articular surface replacement device, which DePuy marketed under the name ASR — in November 2009 and formally recalled them in August 2010 amid reports in databases of orthopedic patients abroad showing they were failing prematurely at high rates.
But in a confidential letter, the F.D.A. told Johnson & Johnson in August 2009 that company studies and clinical data submitted to gain approval in the United States to sell the model available overseas were inadequate to determine the implant’s safety and effectiveness, according to a summary of the letter reviewed by The New York Times.
The agency also told the company it would need added clinical data to pursue the application, a process that would probably have taken a year or more. DePuy’s receipt of the notice came as regulators and surgeons abroad as well as doctors in this country were raising serious questions about growing failures of both models of the implant.
A spokeswoman for DePuy confirmed that the company had received the agency’s so-called nonapproval letter. But the spokeswoman, Mindy Tinsley, declined to release the letter or to respond to questions about when, or if, DePuy disclosed the ruling to doctors, patients, investors or regulators abroad.
A principal researcher on the clinical studies submitted by the company to the F.D.A. said he was not informed of the agency’s decision. Also, a review of publicly available information indicates that the company did not discuss the agency’s nonapproval letter in financial reports or in presentations to analysts while the device remained on the market.
There is no suggestion that Johnson & Johnson broke the law. Regulatory standards in other countries, like those in Europe, for approving the sale of medical devices are typically lower than here. A spokeswoman for a British regulatory agency, the Medicines and Healthcare Products Regulatory Agency, said that companies like Johnson & Johnson were not required to notify it when the F.D.A. refused to approve a product that was used in patients there.
However, the F.D.A.’s rejection may further deepen the company’s legal and financial problems surrounding the ASR. Last month, the company took a special $3 billion charge, much of it related to anticipated legal and medical expenses associated with the recall. An estimated 5,000 lawsuits involving the device are pending, including some from patients crippled by tiny particles of metallic debris shed by the implants.
William Vodra, a lawyer who specializes in F.D.A. regulation, said that, in general, drug and medical device makers typically disclose nonapproval letters if they might have a material impact on a company’s finances. Mr. Vodra added that apart from that financial calculation, there was no hard-and-fast rule about making such rulings public.
Mr. Vodra said that if a company decided to withhold a nonapproval letter that contained important safety information about a device used by doctors, it could face damage to its brand. “They have to think long and hard of the reputational impact,” he said.
The handling of the ASR highlights how the F.D.A., by keeping its approval process confidential, may affect the health and safety of patients. An agency spokesman, Morgan Liscinsky, declined to disclose the letter on the ASR, saying the agency had a policy of not releasing such notices because they might contain confidential business information.
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Fruit fly larvae and wasp
What’s the News: Fruit fly larvae have unusually high alcohol tolerance, which scientists used to think was because they happen to feed on yeast in rotting fruit. Turns out they’re in it for the alcohol, too—as medication. According to a
new study*, alcohol protects them from the wasp parasites that lay eggs in fruit fly larvae.
How the Heck
Drosophila melanogaster
(fruit fly larvae were fed food either with or without ethanol. Researchers observed that wasps are less likely to lay their eggs into larvae that have eaten alcoholic food. When the wasps did lay their eggs in the alcohol-fed fruit fly larvae, they were less likely to survive. Dissections revealed that wasp larvae developing in the alcoholic environmental had abnormalities like inverted body parts. Fruit fly larvae usually have a natural immune response to the parasite, but alcohol seems to be somehow suppressing that response while also killing the wasp parasite. When the fruit fly larvae get infected, they actually crawl over to the side of the petri dish with alcoholic food. It’s like going to the drug store when you get sick. There’s another neat twist to the experiment ...
Former Food and Drug Administration commissioner Andrew Von Eschenbach, who ran the agency from 2005 to 2009 and has now decamped to the conservative Manhattan Institute, had this advice for reforming the agency in this morning's
Wall Street Journal
:
(Reform means creating FDA pilot programs to bring promising therapies to patients more quickly by allowing them to be approved based on safety, with efficacy to be proven in later trials.
recently tested the top 400 lipsticks and found that all of them contain trace amounts of lead. Among the top 10 contaminated brands five are Maybelline and L’Oreal, owned by L’Oreal USA, two Cover Girl, two NARS lipsticks, and one from Stargazer, according to the FDA’s data. The lipstick with the highest concentration of lead was Maybelline’s Color Sensational “Pink Petal” with a concentration of 7.19 parts per million. But the average concentration out of the 400 lipsticks tested was 1.11 parts per million, well below the proposed limit of 10 parts per million. The Campaign for Safe Cosmetics raised concerns to the FDA urging them to set limits to the amount of lead allowable in cosmetic products. In 2007 the campaign tested 33 lipsticks and found two-thirds of them contained lead and one-third surpassed the FDA’s lead limit for candy, according to TheSpec.com.
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