FDA pledges openness on gene-altered products By RICARDO ALONSO-ZALDIVAR Associated Press
WASHINGTON – Federal health officials Thursday pledged a new,
open process for approving drugs and foods from genetically engineered animals.
Consumer groups complained the policy won't do enough to tell people if they're eating gene-altered animals and fails to
protect the environment. They urged the incoming Obama administration to reconsider it.
Genetic engineering, already widely used for crops, is on the threshold of producing animals that can grow faster or even
yield drugs that treat human illnesses. Although the potential benefits — and profits — are huge, many individuals
have qualms about manipulating the genetic code of other living creatures.
In issuing its long-awaited final policy, the Food and Drug Administration said it will not allow any products from genetically
engineered animals to be sold without first submitting them to scrutiny by independent advisers at a public meeting. The government
will allow exceptions for research animals, such as lab rats, and the FDA will post those on its Web site.
Genetically engineered — or GE — animals are not clones, which the FDA has already said are safe to eat. Clones
are exact copies of an animal. With GE animals, their DNA has been altered to produce a desirable characteristic.
"We will not approve any application until we are convinced of the safety and effectiveness," said FDA biotechnology expert
Larisa Rudenko, who has been working on the complex issue since 1989. "The public should rest assured that we are not going
to be rushing any decisions."
But consumer groups said the FDA's policy will not require all genetically engineered foods to be labeled as such. And
they said the government has not done enough to examine the potential impact of genetically engineered animals on the environment,
particularly if some escape and begin to mate with animals in nature.
"They are completely ignoring consumers' overwhelming desire for labeling," said Michael Hansen, a senior scientist with
Consumers Union, publisher of Consumer Reports. FDA officials said genetically engineered foods will be labeled if they are
different in some important way from natural foods, for example, no-fat filet mignon.
The FDA also failed to require a cradle-to-grave tracking system for genetically engineered animals, said Gregory Jaffe,
who heads the biotechnology project at the Center for Science in the Public Interest. He's particularly concerned about animals
that are not supposed to enter the food supply chain.
"The FDA has made some small but important changes to increase the transparency of this process," said Jaffe. "It helps,
but the devil is in the details."
While not calling for a repeal of the FDA policy, Jaffe urged the incoming Obama administration to work with Congress on
a new law that specifically addresses the genetic engineering issue. The FDA based its policy on older laws that apply to
animal drugs.
Drugs and foods from GE animals will become increasingly common in the next five to ten years. For example, an FDA advisory
committee last week considered approval of an anti-clotting drug produced from the milk of GE goats. The scientific advisers
concluded that the drug — ATryn — appears to be safe and effective. A final FDA decision is pending. And a Massachusetts
company hopes to win FDA approval this year for a faster-growing salmon.
The biotechnology industry welcomed the FDA's announcement.
"This system will ensure the products made available through this science will go through a rigorous and transparent review
process before being approved for the marketplace," said Barbara Glenn, a senior scientific adviser with the Biotechnology
Industry Organization.
Govt Pays Millions for Unapproved Drugs By RICARDO ALONSO-ZALDIVAR and FRANK BASS Associated Press
WASHINGTON – Taxpayers have shelled out at least $200 million
since 2004 for medications that have never been reviewed by the government for safety and effectiveness but are still covered
under Medicaid, an Associated Press analysis of federal data has found. Millions of private patients are taking such drugs,
as well.
The availability of unapproved prescription drugs to the public may create a dangerous false sense of security. Dozens
of deaths have been linked to them.
The medications date back decades, before the Food and Drug Administration tightened its review of drugs in the early 1960s.
The FDA says it is trying to squeeze them from the market, but conflicting federal laws allow the Medicaid health program
for low-income people to pay for them.
The AP analysis found that Medicaid paid nearly $198 million from 2004 to 2007 for more than 100 unapproved drugs, mostly
for common conditions such as colds and pain. Data for 2008 were not available but unapproved drugs still are being sold.
The AP checked the medications against FDA databases, using agency guidelines to determine if they were unapproved. The FDA
says there may be thousands of such drugs on the market.
Medicaid officials acknowledge the problem, but say they need help from Congress to fix it. The FDA and Medicaid are part
of the Health and Human Services Department, but the FDA has yet to compile a master list of unapproved drugs, and Medicaid
— which may be the biggest purchaser — keeps paying.
"I think this is something we ought to look at very hard, and we ought to fix it," said Medicaid chief Herb Kuhn. "It raises
a whole set of questions, not only in terms of safety, but in the efficiency of the program — to make sure we are getting
the right set of services for beneficiaries."
At a time when families, businesses and government are struggling with health care costs and 46 million people are uninsured,
payments for questionable medications amount to an unplugged leak in the system.
Sen. Charles Grassley, R-Iowa, has asked the HHS inspector general to investigate.
That unapproved prescription drugs can be sold in the United States surprises even doctors and pharmacists. But the FDA
estimates they account for 2 percent of all prescriptions filled by U.S. pharmacies, about 72 million scripts a year. Private
insurance plans also cover them.
The roots of the problem go back in time, tangled in layers of legalese.
It wasn't until 1962 that Congress ordered the FDA to review all new medications for effectiveness. Thousands of drugs
already on the market were also supposed to be evaluated. But some manufacturers claimed their medications were "grandfathered"
under earlier laws, and even under the 1962 bill.
Then, in the early 1980s, a safety scandal erupted over one of those medications. E-Ferol, a high potency vitamin E injection,
was linked to serious reactions in some 100 premature babies, 40 of whom died.
In response, the FDA started a program to weed out drugs it had never reviewed scientifically. Yet some medications continued
to escape scrutiny.
Sometimes, the medications do not help patients. In other cases, the FDA says, they have made people sicker, maybe even
killed them. This year, for example, the FDA banned injectable versions of a gout drug called colchicine after receiving reports
of 23 deaths. Investigators found the unapproved drug had a very narrow margin of safety, and patients easily could receive
a toxic dose leading to complications such as organ failure.
Critics say the FDA's case-by-case enforcement approach is not working.
"The FDA does not appear to have a systematic mechanism to report these drugs out," said Jon Glaudemans, senior vice president
of Avalere Health, a health care industry information company, "and there doesn't seem to be a systematic process by which
health insurance programs can validate their status. And everyone is pointing the finger at someone else as to why we can't
get there."
In most cases, doctors, pharmacists and patients are not aware the drugs are unapproved.
"Over the years, they have become fully entrenched in the system," said Patti Manolakis, a Charlotte, N.C., pharmacist
who has studied the issue. Only a few unapproved drugs are truly essential and should remain on the market, she added.
Tackling the problem is made harder by confusing — and sometimes conflicting — laws, regulations and responsibilities
that pertain to different government agencies.
Medicaid officials said their program, which serves the poor and disabled, is allowed to pay for unapproved drugs until
the FDA orders a specific medication off the market. But that can take years.
Compare that with Medicare, the health care program for older people.
Medicare's prescription program is not supposed to cover unapproved drugs. Medicare has purged hundreds of such medications
from its coverage lists, but continues to find others.
It might be easier to sort things out if the FDA compiled a master list of unapproved drugs, but the agency hasn't. FDA
officials say that would be difficult because many manufacturers do not list unapproved products with the agency. Yet, the
AP found many that were listed — a possible starting point for a list.
Among the drugs the AP's research identified were Carbofed, for colds and flu; Hylira, a dry skin ointment; Andehist, a
decongestant, and ICAR Prenatal, a vitamin tablet. Medicaid data show the program paid $7.3 million for Carbofed products
from 2004 to 2007; $146,000 for Hylira; $4.8 million for Andehist products, and $900,000 for ICAR.
Grassley said the system is failing taxpayers and consumers.
"The problem I see is bureaucrats don't want to make a decision," Grassley said. "There is no reason why this should be
such a house of mirrors when so much public money is being spent." Grassley is considering introducing legislation to ensure
that consumers are told when a medication is unapproved.
FDA officials say they tell Medicaid and Medicare when the agency moves to ban an unapproved drug, so the programs can
stop paying.
"The situation is complicated by the fact that Medicaid and Medicare have a different regulatory regime than FDA does,"
said FDA compliance lawyer Michael Levy. "There are products that we may consider to be illegally marketed that could be legally
reimbursed under their law."
The FDA began its latest crackdown on unapproved drugs two years ago and has taken action against nine types of medications
and dozens of companies. Typically, the agency orders manufacturers to stop making and shipping drugs, and it also has seized
millions of dollars' worth of medications. But federal law does not provide fines for selling unapproved drugs, and criminal
prosecutions are rare.
Some manufacturers of unapproved drugs say their products predate FDA regulation and are "grandfathered in."
"These are drugs that don't require an FDA approval," said Bill Peters, chief financial officer of Hi-Tech Pharmacal in
Amityville, N.Y. "These are products with active ingredients that have been on the market for a long time." The company is
moving away from older products, Peters said, and its new market offerings are FDA-approved.
Levy said the FDA is skeptical that any drugs now being sold are entitled to "grandfather" status. To qualify, they would
have to be identical to medications sold decades ago in formulation and other important aspects.
The agency is targeting drugs linked to fraud, ones that do not work and, above all, those with safety risks. While the
crackdown has helped, it does not appear to have solved the problem.
The gout drug banned by the FDA this February is not the only recent case involving safety problems.
Last year, the FDA banned unapproved cough medicines containing hydrocodone, a potent narcotic. Some had directions for
medicating children as young as age 2, although no hydrocodone cough products have been shown to be safe and effective for
children under 6.
In a 2006 case, the agency received 21 reports of children younger than 2 who died after taking unapproved cold and allergy
medications containing carbinoxamine, an allergy drug that also acts as a powerful sedative. Regulators banned all products
that contained carbinoxamine in combination with other cold medicines.
"We as Americans have a belief that all the prescription drugs that are available to us have been reviewed and approved
by the FDA," said Manolakis, the pharmacist. "I think the presence of these drugs shows we have a false sense of security."
Milk off shelves as China's safety scandal grows By GILLIAN WONG Associated Press
China's food safety crisis widened Friday after the industrial chemical
melamine was found in milk produced by three of the country's leading dairy companies — prompting stores, including
Starbucks, to yank milk from their shelves.
The recalls come as evidence is mounting that adding chemicals to watered-down milk was a widespread practice in China's
dairy industry.
Sipping from a carton of milk at a news conference, the chief financial officer of one of the companies, Mengniu, apologized
for the tainted milk. But he insisted only a small portion of the company's inventory had been contaminated and said the tainted
milk came from small-scale dairy farmers.
"Large-scale milk farms are very disciplined. They won't take the risk to do something like that," Yao Tongshan told reporters
in Hong Kong.
The crisis was initially thought to have been confined to tainted milk powder, used to make baby formula that has been
blamed in the deaths of four infants and for sickening 6,200 other children.
But tests found melamine in samples of liquid milk taken from China's two largest dairy producers, Mengniu Dairy Group
Co. and Yili Industrial Group Co., as well as Shanghai-based Bright Dairy. The chemical, which is used in plastics and fertilizers,
can cause kidney stones and lead to kidney failure.
All batches that tested positive were being recalled, China's product safety watchdog said in a report on its Web site.
It pledged to "severely punish those who are responsible."
Melamine, which is high in nitrogen, makes products with it appear higher in protein. Suppliers trying to cut costs are
believed to have added it to watered-down milk to cover up the resulting protein deficiency.
No tainted infant formula has turned up in the United States, where authorities have inspected more than 1,000 retail markets
mainly serving Asian communities. China is an importer of liquid milk, so it's unlikely that milk from that country would
have been shipped to the U.S.
But the Food and Drug Administration said it is stepping up inspections at ports as a precaution. Inspectors will be sampling
bulk shipments of food ingredients from Asia that are derived from milk, such as milk powder and whey powder. The FDA also
plans to issue a consumer alert warning people not to buy milk products from China on the Internet.
A senior dairy analyst said Chinese farmers were cutting corners to cope with rising costs for feed and labor.
"Before the melamine incident, I know they could have been adding organic stuff, say animal urine or skin," said Chen Lianfang
of Beijing Orient Agribusiness Consultant Co. "Basically, anything that can boost the protein reading."
But he and others expressed skepticism that so many farmers would know to add melamine to milk. The chemical is not water-soluble
and must be mixed with formaldehyde or another chemical before it can be dissolved in milk.
"Farmers can't be well-educated enough to think of melamine," Chen said. "There must be people from chemical companies
contacting them and telling them it's a good idea."
The product safety agency and the Health Ministry declined to answer questions Friday about how widespread the practice
of adding melamine to milk was believed to be.
"I don't know if this is an industrywide problem, but it is definitely not a single case. It is on a massive scale," said
E.R. Hong, an executive of Hua Xia Dairy Ltd., a U.S.-owned dairy farm east of Beijing that has not been accused of supplying
tainted milk.
The crisis highlights the growing influence of dairy products in the Chinese diet. Milk is not part of the traditional
Chinese diet, but the country's economic growth and the increased availability of refrigeration have brought about a wide
range of products, with flavored milk and sweetened yogurts among the most popular.
Though per capita consumption of dairy products in China is still low at 1.5 ounces per day, increasingly affluent Chinese
consumers are paying more attention to their health and view milk as highly nutritious, particularly for children.
The crisis has raised questions about the effectiveness of tighter controls China promised after a series of food safety
scares in recent years over contaminated seafood, toothpaste and a pet food ingredient tainted with melamine that was blamed
for the deaths of dogs and cats in the United States. In 2004, more than 200 Chinese infants suffered malnutrition and at
least 12 died after being fed phony formula that contained no nutrients.
Reactions to the latest recalls were immediate.
Starbucks Corp. said its 300 cafes in mainland China were pulling all milk supplied by Mengniu, though the Seattle-based
company said no employees or customers had fallen ill from the milk.
Major Hong Kong grocery chains PARKnSHOP and Wellcome ordered Mengniu liquid milk removed from their shelves Friday, a
day after products made by Yili, including milk, yogurt and ice cream, were taken off. Singapore suspended the sale and import
of all Chinese milk and dairy products Friday.
Meanwhile, two distributors of Sanlu baby formula said the company ordered them to pull its products off shelves in early
July, weeks before it announced its milk powder was contaminated.
The statements raised further questions about when the company and government knew the formula was contaminated.
Sanlu received complaints as early as March and tests in early August found the milk powder contained melamine. However,
no recall was ordered until Sept. 11, after its New Zealand stakeholder told the New Zealand government, which then informed
the Chinese officials.
One of the distributors, Zhang Youqiang, said Sanlu ordered all formula with production dates from 2007 to July 2008 be
yanked from shelves.
"Then things got weird. In early August, they came to us again and said all the new Sanlu baby milk powder we had just
put on the shelves" did not meet a government standard unrelated to product quality, said Zhang, who declined to name the
distributor he works for in Hebei province.
Another distributor, Liang Jianqiang, said he also took Sanlu baby milk powder out of stores in July. "They told me there
would be a new formula that's better quality. They did this again in August and September," he said.
Phone calls to Sanlu rang unanswered Friday, and its Web site was not working. China's quality watchdog did not respond
after asking that questions be faxed over.
Warning on Certain Types of Raw Red Tomatoes
The Food and Drug Administration (FDA) is alerting consumers in New Mexico and Texas that a salmonellosis
outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes.
The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella.
Salmonella can cause serious and sometimes fatal infections particularly in young children,
frail or elderly people, and those with weakened immune systems. Healthy people often experience fever, diarrhea (which may
be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, the organism can get into the bloodstream and produce
more severe illnesses.
Preliminary Data
The specific type and source of tomatoes are under investigation. However, preliminary
data suggest that raw red plum, red Roma, or round red tomatoes are the cause.
There have been 57 reported cases of salmonellosis caused by Salmonella Saintpaul in New Mexico
and Texas, including 17 hospitalizations. Approximately 30 reports of illness in Arizona, Colorado, Idaho, Illinois,
Indiana, Kansas, and Utah are currently being investigated to determine whether they are also linked to tomatoes. There are
no reported deaths.
Advice for Consumers
At this time, consumers in New Mexico and Texas should limit their tomato consumption to tomatoes
that have not been implicated in the outbreak. These include cherry tomatoes, grape tomatoes, tomatoes sold with the vine
still attached, and tomatoes grown at home.
Consumers in New Mexico and Texas who have recently eaten raw tomatoes or foods containing raw tomatoes
and are experiencing any of these symptoms should contact their health care provider. All Salmonella infections should
be reported to state or local health authorities.
Investigation Continues
FDA recognizes that the source of the contaminated tomatoes may be limited to a single
grower or packer or tomatoes from a specific geographic area. FDA also recognizes that there are many tomato crops across
the country and in foreign countries that are just becoming ready for harvest or will become ready in the coming months.
To ensure that consumers can continue to enjoy tomatoes that are safe to eat, FDA is working diligently
with the states, the Centers for Disease Control and Prevention, the Indian Health Service, and various food industry trade
associations to quickly determine the source and type of the contaminated tomatoes. As more information becomes available,
FDA will update this warning.
The Food and Drug Administration (FDA), about a week ago announced that the milk and meat from Cloned
animals is safe to eat and drink. The FDA said that the milk and the meat are “indistinguishable” from animals
that are bred and raised in conventional methods. The decision removes the last big U.S. regulatory hurdle to marketing products
from cloned livestock such as Cow and Pigs.
So why has the FDA rushed the approval?
The FDA in their normal haste to appease manufacturers
so they can get their products to market has again favored another industry over the concerns of the consumer.
Companies like ViaGen, a subsidiary of Exeter Life Sciences
in Austin, Texas, and Cyagra, which offer livestock-cloning services to ranchers for replicating their most elite sires and
dams, have been waiting several years for a final say from the FDA.
In 2001, the FDA put a voluntary suspension on the sale
of these items, so they could begin their study of the risks that may be associated with food from Cloned animals.
The findings by the FDA Center for Veterinary Medicine
will be published and made available, and states that none of their studies show,”any remarkable nutritionally or toxicologically
important differences” in the meat and milk from Cloned animals. The only problem with that is that the industry is
new and no long term studies have been made, because they can’t.
I'll have a Clone Burger with Fries to Go
Coming to you soon (a couple of years until they get
the costs down) you may be eating a clone burger with your fries, and you won’t even know it, because the FDA will not
require any labels that say, “From Cloned Animals.”
The FDA is saying that a glass of milk and a hamburger
from a Cloned animal, will taste exactly the same as those from naturally bred animals, and that there are no differences.
But there are differences, big differences; a Clone
is created in a lab, to be an exact duplicate of an existing conventionally bred animal.
With cloning also come ethical concerns that are not
found in the conventional process of breeding. The process itself has a very high risk of birth defects, and the mere fact
that it is created in a lab, would make many wonder if this is morally acceptable.
Many soon will be faced with a choice, do I want to
eat and drink products from Cloned animals, or just avoid them altogether because of ethical reasons, or some other personal
reason.
The FDA says that you the consumer will not have the
option of knowing whether your meat and milk are from Cloned animals. The FDA said that they have NO plans, for the requirement
of labels. The FDA is saying that, if you, the consumer have an ethical or moral problem with Clones, they also don’t
care.
As a consumer of meat and milk by-products, I personally
want to know what kind of food I am putting in my mouth, and where it comes from, or at least I want the option of being able
to know, and I think that there are millions of people that feel that same as I do.
I urge everyone who cares about what they eat or that
may have an ethical or moral problem with Cloned milk and meats, to contact their elected officials, and tell them to have
the FDA require Labels.
David Phillips is a Vietnam Era Veteran, a Democratic Party Activist,
and David is also the Publisher and Editor of the online political magazine YodasWorld.org
You can also read David’s weekly column in the Santa Ynez Valley Journal or you can go to
their web site: www.Syvjournal.com
FDA Expected To Declare Cloned Meat And Milk Safe By staff reporter
The Food and Drug Administration is expected to declare
that meat and milk from cloned animals safe to enter the American food supply, according to the Wall Street Journal.
The announcement of an amendment to the Farm Bill (H.R. 2419) at the end of last year suggested that approval for cloned
food was far away. Moreover, the FDA had previously asked cloned animal producers not to sell animals until it announces the
results of its ruling on safety, said the Journal.
But an unnamed source indicated to the Wall Street Journal that the FDA is set to declare the meat and dairy of the animals
safe as early as next week.
FDA in December issued its assessment of the available scientific evidence surrounding cloning, which concluded that there
were no additional safety risks posed by the technology when compared to other assisted reproductive technologies currently
in use in US agriculture.
However, Senators Barbara Mikulski and Arlen Specter proposed amendment 3524 to address concerns that the US Food and Drug
Administration's (FDA) risk assessment of the controversial technology was flawed.
Furthermore, the Center for Food Safety (CFS), a non-profit science-based public interest group, released a review of the
FDA's risk assessment agreeing with the senators, stating that FDA's assessment was based on "flawed assumptions and misrepresented
findings", and claimed that FDA found virtually no scientific evidence to support the commercial release of these experimental
foods.
"Animal cloning is a new technology with potentially severe risks for food safety. Defects in clones are common, and cloning
scientists warn that even small imbalances in clones could lead to hidden food safety problems in clones' milk or meat. There
are few studies on the risks of food from clones, and no long-term food safety studies have been done," the group states on
its website.
Despite new noises indicating an imminent safety green light, it could be between three and five years before meat and
milk from cloned animals reaches the shelves and consumers' mouths, according to the Wall Street Journal. This is because
of the costs involved in producing a cloned animal - reported to be between $15,000 and $20,000 per animal.
Results of a consumer survey in July 2007 showed that 50 percent of American consumers have an unfavorable view of cloning,
while 28 percent remain neutral. The national survey, commissioned by the International Food Information Council (IFIC), reported
that only 22 percent of the 1,000 people interviewed viewed animal cloning in a favorable light.
However, the survey did find that if FDA determined that foods from cloned animals are safe, 46 percent of consumers would
view the technology favorably, with 49 percent saying they would likely purchase such products if safety determinations were
offered.
FDA News
FOR IMMEDIATE RELEASE November 16, 2007
Media Inquiries: Brad A. Swezey, 301-827-6242 Consumer
Inquiries: 888-INFO-FDA
Approximately $2 Million of Potentially Harmful "Cosmetic"
Eye Product Seized Product contains drug ingredient, makes unapproved drug claims, could damage
eye
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized today 12,682 applicator
tubes of Age Intervention Eyelash, a product that may, in some users, lead to decreased vision. Authorities said the sales
value of the seized tubes is approximately $2 million.
Age Intervention Eyelash is sold and distributed by Jan Marini Skin Research, Inc., of San Jose, Calif.
The FDA considers Age Intervention Eyelash to be an unapproved and misbranded drug because Jan Marini
Skin Research has promoted the product to increase eyelash growth. Before a new drug product may be legally marketed, it must
be shown to be safe and effective, and approved by FDA. The agency takes seriously its responsibility to protect Americans
from unapproved drugs.
FDA also considers the seized Age Intervention Eyelash to be an adulterated cosmetic. The product contains
bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (elevated pressure inside
the eye).
For patients using the prescription drug, using the Age Intervention Eyelash in addition to the drug
may increase the risk of optic nerve damage because the extra dose of bimatoprost may decrease the prescription drug's effectiveness.
Damage to the optic nerve may lead to decreased vision and possibly blindness.
In addition, use of Age Intervention Eyelash may cause other adverse effects in certain people due
to the bimatoprost, including macular edema (swelling of the retina) and uveitis (inflammation in the eye), which may lead
to decreased vision.
The U.S. Attorney's Office for the Northern District of California filed the complaint requesting the
seizure, and coordinated with the FDA. The California Department of Public Health‘s Food and Drug Branch had previously
embargoed the seized products at the San Jose facility. Jan Marini Skin Research has notified FDA that the company ceased
manufacturing and shipping any Age Intervention Eyelash product containing bimatoprost last year.
The FDA recommends that consumers, dermatologists, and estheticians who may still have Age Intervention
Eyelash discontinue using it and discard any remaining product. FDA also recommends that consumers consult their health care
provider if they have experienced any adverse events that they suspect are related to the product's use.
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