FDA Is Criticized for Training Deals.

http://online.wsj.com/article/SB10001424052748704865104575588312774998510.html?mod=WSJ_hpp_sections_health


The FDA"s bogus waste of YOUR tax dollars.
Why is there a backlog of generic drug apps?
Because big Pharma wants it that way, they have no desire to have those apps approved because it takes money out of their pocket.
So through the use of lobbyists, they ensure through the buying off of political positions, so that their bottom line is never touched, and those bought off political positions ensure that your tax dollars are wasted by the bogus misdirection of the given appropriations to ease the problem in the first place.
Here is a prime example.
Lobbyism is nothing more than the insurance for a totally corrupt government.


"Why on earth are FDA managers spending money for a consultant to tell them why they have a backlog of generic drug applications?" said Rep. Joe Barton of Texas, the top Republican on the House Energy and Commerce Committee.

An FDA spokeswoman said McKinsey's work for the generic-drug office was only a small part of the firm's overall contract with the FDA set up earlier this year.

According to government documents, the goal of the contract is to "ensure that the decisions made by the FDA can be tracked through and supported by clearly communicated and documented processes."

McKinsey declined to comment, saying it doesn't discuss clients.

It isn't the first time an outside contract for FDA management training has raised concerns in Congress. In 2008, the agency held a $1.5 million seminar for 500 senior employees who were shown a slideshow comparing Dr. Woodcock with such leaders as Gandhi and Golda Meir.

F.D.A. Unveils Graphic Warning Labels for Cigarettes

http://www.nytimes.com/2010/11/11/health/policy/11tobacco.html?ref=us

Time to invest in cigarette cases kids.
It gonna be the next new trend.
What a ridiculous waste of money by the "Morality Police"
I wonder if they'll put rotten livers on all alcohol products, and brain tumors on cell phones or a rotted stomach on toothpaste for the fluoride warning? I could go on but I won't, because I'm sure you get my drift.
But I do have one question that needs answering!
Who the fuck is running this country anymore and just who the do they think they are?
God?

Federal drug regulators unveiled 36 proposed warning labels for cigarette packages on Wednesday, including some that are striking pictures of smoking’s effects.

Designed to cover half of a pack’s surface area, the new labels are intended to spur smokers to quit by providing graphic reminders of tobacco’s dangers. The labels are required under a law passed last year that gave the Food and Drug Administration the power to regulate tobacco products for the first time

FDA in Rare Reversal of Approval of Medical Device

http://www.allgov.com/Controversies/ViewNews/FDA_in_Rare_Reversal_of_Approval_of_Medical_Device_101017

Lobbying while on duty for the state of New Jersey?
Hey they're supposed to do that AFTER they leave office
Heree's your government America
What was approved in your medicine cabinet and who got bought off put it there?
Do you ever listen to those drug ads on TV and the side effects that have been reported for that particular drug of the ad?
My favorite one is Advair, my husband and I laugh and laugh every time it comes on.
Here's why:
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use Advair:

a food or drug allergy;

heart disease or high blood pressure;

epilepsy or other seizure disorder;

an infection of any kind;

a weak immune system;

diabetes;

glaucoma;

tuberculosis;

osteoporosis;

a thyroid disorder; or

liver disease.
FDA pregnancy category C. It is not known whether Advair is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether fluticasone and salmeterol passes into breast milk or if it could harm a nursing baby. Do not use Advair without telling your doctor if you are breast-feeding a baby.

See also: Pregnancy and breastfeeding warnings in more detail

Advair can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Do not give this medication to a child younger than 4 years old.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis.




Read more: http://www.drugs.com/advair.html#ixzz1312xrFa7

Well now you know how it got to be for sale.


The Food and Drug Administration has changed its mind about a patch for injured knees, and withdrawn its approval for the product that was originally allowed on the market after four politicians from New Jersey pressured regulators into making their decision.

The about-face on Menaflex was a first in many ways for the FDA.

According to The New York Times, the agency “had never before admitted that it approved a drug or device mistakenly, never rescinded such an approval without citing new information about the product, never admitted that a regulatory decision was influenced by politics, and never accused a former commissioner of questionable conduct.”

FDA scientists said they did not recommend Menaflex for approval. But higher-ups overruled the expert opinions after four Democrats from New Jersey—Senators Robert Menendez and Frank R. Lautenberg and Representatives Frank Pallone Jr. and Steven R. Rothman—lobbied the FDA on the company’s behalf, and it was approved in December 2008

CRA petitions FDA for high fructose corn syrup name change

http://www.foodnavigator-usa.com/Financial-Industry/CRA-petitions-FDA-for-high-fructose-corn-syrup-name-change/?c=TJ6pZf%2BpD7ccYz9WI0MGPw%3D%3D&utm_source=newsletter_daily&utm_medium=email&utm_campaign=Newsletter%2BDaily

Lol You didn't think they were just going to go away did you.

The Corn Refiners Association has petitioned the Food and Drug Administration (FDA) asking it to allow the term ‘corn sugar’ as an alternative label declaration for high fructose corn syrup (HFCS).

HFCS has suffered from a spate of bad publicity in recent years, and food and beverage manufacturers have been increasingly switching it out of their products in preference for beet or cane sugar (sucrose).

The Corn Refiners Association (CRA) has said that the reason it filed a petition with the FDA was to be clear with consumers about what HFCS is: A sugar made from corn. The CRA – a trade association that represents the corn refining industry in the United States – has repeatedly stressed that HFCS is not high in fructose, even though that is what the name may suggest. In fact it contains proportions of fructose and glucose that are similar to sucrose.

Farms fell short on safety, FDA chief says

http://www.cnn.com/2010/HEALTH/08/22/eggs.salmonella/index.html?iref=NS1

The question is whose job is it to make sure that those farms don't fall down on safety, because they didn't do their job, and now the public is suffering for it. The public deserves better than this and the kicker is I know we pay as taxpayers for the position to ensure it does get done.
Perhaps it's time to restructure some of those priorities at the FDA, that kept them from ensuring that this kind of thing, doesn't happen again.



The companies that have recalled more than half a billion eggs following a salmonella outbreak fell short of safety standards at their farms, FDA Commissioner Margaret Hamburg said Sunday.

"There's no question these farms involved in the recall were not operating with the standards of practice we consider responsible," Hamburg told CNN.

She said "about 1,000" people have been sickened by a salmonella outbreak that federal regulators have traced back to two Iowa egg producers

Tylenol recall

http://money.cnn.com/2010/05/25/news/companies/tylenol_recall_adverse_consumer_complaints/index.htm

I just can't get past the low level of quality control.
It's everywhere I turn.
Politicians,Banks,Oil spills,Pharma, Autos,Insurance, ect....ect......
It would seem nothing is working properly anymore

The Food and Drug Administration is looking into reports of at least 775 serious side effects from drugs recalled by McNeil, a division of Johnson & Johnson, according to a source close to a Congressional investigation.

Included in the reports were 30 deaths, nearly all of which were found to not be tied to McNeil's recall of Tylenol, Motrin and Benadryl drugs from Jan. 1, 2008 through April 30, 2010, according to another source close to the investigation.


The FDA is also investigating reports of several hundred serious side effects -- or "adverse events" -- and seven deaths since May 1, when McNeil recalled 50 children's versions of these non-prescription medicines because of serious quality and safety concerns.

FDA approves Glaxo's cervical cancer vaccine

http://finance.yahoo.com/news/FDA-approves-Glaxos-cervical-apf-2176177020.html?x=0&sec=topStories&pos=3&asset=&ccode=

Injection age starts at 8 now for boys and girls for a virus that is spread primarily by sexual contact for a disease that shows up in women in their 50's.
How much sense does it make to shoot this poison into a child?
Actually none unless your on the monetary receiving end of Pharma, which then makes it a "life saver".

HPV infects about 6 million people in the U.S. each year, and is spread mainly through sexual contact. It usually causes no symptoms and goes away within two years, although rare cases can develop into warts and cancer in both men and women.

Last year, nearly 4,000 women died of cervical cancer in the U.S., less than 1 percent of all deaths from cancer

FDA Panel OKs HPV Vaccine Gardasil for Boys

http://www.webmd.com/sexual-conditions/hpv-genital-warts/news/20090909/fda-panel-oks-gardasil-for-boys

How many times has your child fainted from an injection? Merck says this is quite a common occurrence in adolescence.
One truly has to wonder how many 9 year olds have had exposure to sexually transmitted diseases for them to be able to make a claim that it's 89% effective, or were they exposed to genital warts purposely to enable Merck to validate their findings?


An FDA advisory committee voted to recommend approval of the vaccine Gardasil for males ages 9 to 26 to prevent genital warts.

Gardasil targets four strains of human papillomavirus, commonly called HPV. Males can carry HPV and transmit it sexually to their partners.

HPV can cause genital warts and penile and anal cancer in men. Each year, about 200 out of 100,000 males are newly diagnosed with genital warts, according to background information cited by the FDA. Penile cancer and anal cancer are much rarer.

Gardasil already has FDA approval for use in females ages 9 to 26. In females, HPV can cause cervical cancer.

The FDA advisory committee ruled 7 to 0, with one abstaining vote, that Gardasil's clinical trial data support the vaccine's effectiveness at preventing genital warts in males ages 9 to 26. And in a 7 to 1 vote, the advisory committee ruled that the data show Gardasil to be safe for males in that age range.

The FDA advisory committeereviewed three studies of Gardasil that together included more than 5,000 males ages 9 to 26 in various countries including the U.S.

Participants got a total of three shots of Gardasil or a placebo spread over six months. They also got checkups and tests to check for HPV infection.

Gardasil was 89% effective in preventing genital warts. The vaccine was less effective in participants who had already been exposed to HPV.

No serious side effects were seen, according to information posted on the FDA's web site.
------------------------------------------------------------------------------
http://www.cdc.gov/vaccinesafety/vaers/gardasil.htm

Non-serious adverse event reports

VAERS defines non-serious adverse events as those other than hospitalization, death, permanent disability, and life-threatening illness.

The vast majority (93%) of the adverse events reports following Gardasil have been non-serious. Reports of non-serious adverse events after Gardasil vaccination have included fainting, pain and swelling at the injection site (the arm), headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries, which can be prevented by closely observing the vaccinated person for 15 minutes after vaccination.

Serious adverse event reports

VAERS defines serious adverse events as adverse events that involve hospitalization, permanent disability, life-threatening illness, and death. As with all VAERS reports, serious events may or may not have been caused by the vaccine

Breast cancer 'wonder drug' increases risk of rare tumour by 440%

http://www.dailymail.co.uk/health/article-1208966/Breast-cancer-wonder-drug-increases-risk-rare-tumour-440.html

And rather than admit this drug to be the failure that it is, they will create a new drug to eradicate the more dangerous tumors that it creates as a secondary cancer from it's use.
I ask you America and the world for that matter, How much longer will you put up with this treatment of abuse?
It's clearly obvious that you are nothing more than a cow to be milked by the medical community and big pharma.


Breast cancer patients given tamoxifen are more than four times more likely to develop a more aggressive tumour than those not prescribed the drug, scientists have warned.

A study of over 1,000 patients found the oestrogen blocking drug reduced the risk of the most common, easy to treat cancer recurring by 60 per cent.

But the chances of a rarer type not sensitive to the female hormone appearing in the opposite breast increased by an alarming 440 per cent.

These are known as ER negative tumours, as opposed to ER positive, and are much more dangerous as there are no drugs that specifically target them.



Read more: http://www.dailymail.co.uk/health/article-1208966/Breast-cancer-wonder-drug-increases-risk-rare-tumour-440.html#ixzz0PLX0xoVR

Monsanto's choice to run food safety for the FDA

http://crooksandliars.com/susie-madrak/fox-guard-henhouse-former-monsanto-vp

Seriously do you still think your government isn't bought off


Obama's considering appointing a former Monsanto vice president, Mike Taylor, to head the Food Safety Working Group at the FDA.

As Jill Richardson writes at LaVidaLocavore at the link above, Taylor thinks the FDA wastes too much time on food safety inspections at meat packing plants. Further, he believes that one of their main problems is that they have to slow down their line speed too much.

Everyone who's read anything about the horrendous working conditions at US meatpacking plants knows that incomplete kills before slaughter and worker injuries increase dramatically when line speeds increase.

FDA panel to vote on painkiller restrictions

http://finance.yahoo.com/news/FDA-pa...sset=&cc ode=

No it's not killer drugs they want to pull, it's everything you'd need to combat a cold or the flu. Interesting to say the least don't you think.
Timing is everything

Government experts are scheduled to vote on whether Nyquil and other combination cold medications should be pulled from the market to help curb deadly overdoses.

The Food and Drug Administration has assembled more than 35 experts for a two-day meeting to discuss and vote on ways to prevent overdose with acetaminophen -- the pain-relieving, fever-reducing ingredient in Tylenol and dozens of other prescription and over-the-counter medications.

Despite years of educational campaigns and other federal actions, acetaminophen remains the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA. There are about 200 acetaminophen-related deaths each year.

"It can happen to anybody, but it's very rare," said Dr. Lee Simon, an associate professor at Harvard Medical School, who attended Monday's meeting. "Obviously it's important that we improve the communication about these products because they are ubiquitous, and we still see people inadvertently overdosing."

The drugs that could be pulled off shelves are combination medications, such as Procter & Gamble's NyQuil or Novartis' Theraflu, which mix acetaminophen with other ingredients that treat cough and runny nose.

The FDA is not required to follow the advice of its panels, though it usually does. The panel vote is

The Risks of Genetically Modified Foods

http://www.brasschecktv.com/page/647.html

At 3 minutes and 51 seconds into this video it becomes riveting.


"They knew and didn't tell"

We all know how utterly corrupt the FDA is, but sometimes the full significance of this fact doesn't resonate.

This video is a major wake up call.

Short version:

The FDA gave Monsanto and it friends a free pass on genetically modified organisms.

They've helped suppress the science that shows food produced this way is dangerous.

Here are the foods that are genetically modified: milk, corn, soybeans, canola oil and cottonseed oil.

One simple way to protect yourself is to stop eating these foods unless they come from a certified organic source.

For more information on how to protect yourself from the corporate/government criminals that are selling garbage and poison and calling it food, go here:

http://www.TheRealFoodChannel.com

Ritalin ADHD Drug Linked to 500 Percent Increased Risk of Sudden Death in Children

http://www.naturalnews.com/026459_ad...s_ritalin.html

Just how dangerous are the amphetamine stimulant drugs prescribed for children with so-called ADHD? According to scientific research funded by the FDA and the National Institute of Mental Health, drugs such as Ritalin increase the risk of sudden death by five hundred percent among children and teens.

In these cases of sudden death, the child suddenly collapses and dies, only to be discovered later by parents or siblings. That's what happened to Matthew Hohmann in 2004 (http://abcnews.go.com/Health/MindMo...), and according to this new research, it keeps happening to more and more children at a rate that's 500 percent higher than would be considered typical for children of a similar age and health status.

ADHD drugs like Ritalin are, of course, amphetamine stimulants. They used to be sold on the street as "speed," but now they're prescribed by psychiatrists to children after a subjective diagnosis of a fictitious disease: ADHD -- a "disorder" which has no measurable biological symptoms whatsoever.

Interestingly, the FDA banned ephedra, an herbal stimulant, after a handful of consumers died from consuming huge amounts of the herb in a desperate effort to lose weight. In that case, in banning the herb, the FDA announced "the risks outweigh the benefits," declaring that "ephedra is not safe at any dose."

In great contrast to that, even as children are literally dropping dead after taking ADHD drugs, the FDA is now insisting "the benefits are worth the risks."

FDA says Zicam nasal spray can cause loss of smell

http://finance.yahoo.com/news/FDA-says-Zicam-nasal-spray-apf-15537702.html

Didn't the FDA pass this drug for consumer use in the first place? Why yes it did.
So one would have to assume that long term effects were studied and taken into account or discount as the case may be.
Greed kills. Do you think it's a good idea to allow a potentially mandatory flu vaccine to be fast tracked without the rigors of Zicam's testing to be approved?

The Food and Drug Administration says Zicam nasal spray can permanently damage users' sense of smell.

The FDA says consumers should stop using Zicam Cold Remedy nasal gel and related products immediately. All the over-the-counter products contain zinc. Scientists say that ingredient may damage nerves in the nose needed for smell.

The FDA says about 130
are you to take a fast tracked flu vaccine?

The Food and Drug Administration says Zicam nasal spray can permanently damage users' sense of smell.

The FDA says consumers should stop using Zicam Cold Remedy nasal gel and related products immediately. All the over-the-counter products contain zinc. Scientists say that ingredient may damage nerves in the nose needed for smell.

The FDA says about 130