FDA is the Only Government Agency

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FDA is the Only Government Agency to Get Budget INCREASE

Posted by Dr. Mercola | March 06 2010 | 14,953 views

The Food and Drug Administration is a major exception to the Obama

administration’s freeze on discretionary spending in the 2011 budget.

Overall, the FDA budget could grow by as much as 23 percent, to just over $4

billion. But this will require Congress to authorize more than a quarter-billion

dollars of new fees on food facilities and generic drug makers.

The increase is a testament to the FDA’s increasingly complex

responsibilities, as well as a perception that the agency has been underfunded

for many years. The increased spending would allow the FDA to add 1,200 jobs,

expanding its workforce by 10 percent.

Key boosts in spending would include $318 million to improve food safety, $215

million for anti-smoking programs and $100 million to improve the safety of

drugs and medical devices.

More than one-third of the 2011 budget would come from user fees paid by

businesses that make payments for FDA services such as evaluating new

applications for drugs and medical devices.

Source:   Los Angeles Times February 2, 2010

 

At first glance, this may strike many as good news. And it could be, were it not

for the fact that this budget increase will likely place the FDA even further

into the drug industry’s pocket.

Why?

Because as mentioned in the article, a very large chunk of the 2011 budget

increase will come from user fees paid by the drug industry. And this is one of

the main reasons why the FDA’s track record for keeping you safely out of

harm’s way has failed so miserably over the years.

As I’ve said before, the FDA under its current configuration does more to look

out for itself and to protect its clients – the drug industry – than it does

to protect you, the consumer. And from the looks of this budget, the coming year

is only going to continue the status quo, if not add to the problem.

For example, the FDA’s 604-page budget proposal (it’s not official until

it’s approved by Congress) includes almost $11 million for cost-of-living pay

raises for FDA staff – a perk that I’m positive many Americans wish they

were getting this year.

This me-first attitude is reminiscent of the shenanigans the FDA pulled in 2007

right after it published a 60-page report, admitting that it lacks the

competency and capacity to keep up with scientific advances.

The report was a response to a 332-page analysis of the FDA by the Institute of

Medicine, which basically said the same thing – that the FDA was drowning in

too much to do, with too little money. The IOM faulted the division for

sometimes ignoring FDA scientists' concerns about drug safety, including their

complaints that the division tilts toward industry in decision-making.

So what did FDA officials do to rectify this situation? They hired a consultant

to the tune of $1.5 million, to give morale-boosting seminars to 500 of the

agency’s managers over a two-day period.

No wonder this agency doesn’t have enough money to keep up with its work!

Wouldn’t we all like to go off on a mood-enhancing retreat every time we get

criticized? Once Congress heard about this, enough legislators were fuming to

order an inquiry into the consultant’s contract.

The FDA, though, as reported in The Wall Street Journal, was unrepentant: Even

when confronted with the fact that the consultant also had drug giants Merck,

Pfizer, Novartis, GlaxoKline, and others, as clients, , one of

the FDA’s deputies, flippantly said, “I think it’s quite silly to bring

that up as a point.â€

What is the Point, Then?

The point is, the FDA just doesn’t “get itâ€. Here they are complaining

about not having enough money, so instead of looking for places to cut back,

they go off and spend $1.5 million to help them feel better about it. Where’s

the sense in that?

Likewise, where’s the sense in spending 10 times that much for another

feel-good experience in 2011 in the form of pay increases? But if you take a

look at the budget, you’ll find it only gets better. Throughout the proposal,

pay increases are tied to rent, utilities and other facility costs, as if you

couldn’t have one without the other.

The additional cost of all rent activities, according to the budget, is $22.1

million. Repeatedly, the FDA says, “If FDA does not receive the full amount

necessary to pay the higher pay costs for its employees and higher rent cost for

its facilities, FDA must reduce the professional staff that performs the FDA

mission.â€

Dire warnings of what might happen to the nation’s food supply or to your

personal health and safety without FDA pay raises and facility costs follow this

statement in every instance.

Without knowing exactly what the rent costs are – the General Services

Administration is the landlord – I can’t speculate on what might be inflated

or unnecessary, and therefore possibly cut back.

But I am concerned about the scare tactics the FDA is using to sell its goals

and missions on food safety which, as you will see, are crafted to favor a

multi-national drug cartel giants that most often are more concerned about their

bottom line than you.

The FDA’s Tainted Track Record

There are so many problems with the FDA, it could easily fill an entire book.

Their failure to protect American consumers include whammies like:

the approval of the antibiotic Ketek, despite the fact that the study was so

fraught with fabricated data it led to arrests and prison terms

the deadly Vioxx debacle

antidepressants found to incite murderous and suicidal episodes

lead tainted toys

toxic pet food

And that’s barely scratching the surface.

It should be clear to anyone who has followed the numerous scandals the FDA has

created over the past several years that the FDA main concern is not to protect

you -- they’re interested in protecting the pharmaceutical industry.

And if user fees from the food industry will also become a major source of

funding the FDA’s food safety initiative, you can almost bet that food safety

will deteriorate as quickly and as badly as drug safety has.

A Case of the Fox Guarding the Hen House

The user fees from drug companies, enacted in the 90s, allowed the drug industry

to have major leverage over the FDA, and their control has increased

exponentially ever since.

Back in 2007, when the FDA used increased user fees to fund its expanding

budget, user fees accounted for two-thirds or more of their drug review budget.

As a result, we’ve seen a number of toxic and lethal drugs deemed “safeâ€

and released to market with disastrous results.

The FDA has clearly shown, again and again, that it will stop at nothing to

protect the hand that feeds it.

For example, in January last year, the FDA opted to protect the health and

welfare of big business over the health and welfare of pregnant women and their

unborn babies by claiming that the benefits of eating more than 12 ounces a week

of fatty fish like tuna outweigh the health hazards of mercury.

But they didn’t stop there.

They also had the audacity to claim that mercury is completely harmless!

You may remember this ongoing story. The FDA issued a final regulation

classifying dental amalgam as class II devices (meaning they deem it harmless),

and did not require stringent precautions for pregnant women and children.

This despite the fact that a recent court settlement, filed by the Consumers for

Dental Choice, required the FDA to withdraw claims of mercury amalgam's safety

from its Web site and issue an advisory indicating that:

" Dental amalgams contain mercury, which may have neurotoxic effects on the

nervous systems of developing children and fetuses. "

Their decision stood in direct contradiction of the conclusions of both the

International Academy of Oral Medicine and Toxicology (IAOMT), and the FDA's own

panel of scientific experts! But this was just business as usual at the FDA,

which has a consistent track record of ignoring their own medical and scientific

experts, going as far as firing or harassing them into submission.

For a long list of other FDA debacles through the years, just put “FDA†into

my search engine.

Conflict of Interest Run Rampant at the FDA

One thing is clear, it’s simply not wise to receive a majority of the funding

from the very companies the FDA is seeking to monitor and evaluate and protect

the consumer from. That just violates any shred of common sense.

Rather than increasing drug safety, the FDA has progressively morphed into a

mere pawn and instrument of the drug industry, which has little to do with drug

safety and everything to do with maximizing profits.

The entire operation is fraught with conflict of interest, as their top

officials shuttle back and forth between jobs in government and the industry

they're supposed to be regulating.

If you want to read one of the most fascinating interviews I’ve ever posted on

this site, read the detailed expose by FDA whistle-blower Dr. Graham, the

FDA insider who informed the nation about the Vioxx scandal. His candid remarks

provide amazing insights into just how scandalous the situation really is over

there. A situation that has shown no signs of change.

FDA: We Want Your Dietary Supplements

Another main funding priority for the FDA, introduced early in the budget, is

“Transforming Food Safety.†Now who could be against that? Certainly, I am

one of the strongest proponents of safe foods you’ll ever meet. So what’s

wrong with the FDA making this a top issue?

On the surface, nothing – except that, even though it has a past history of

not being able to take care of the jobs already on its platter, the FDA now

wants another job: regulating wholesome dietary supplements that you may have

setting on your kitchen counter right now.

But where does it say that in this budget? It doesn’t, in so many words. But

with the help of an act of Congress, along with this massive budget increase,

the FDA can, and will, take control of the very vitamins and minerals you may

choose to help maintain your own good health.

Dr. Ron is the constitutionalist Congressman that I interviewed just a few

weeks ago. Dr. believes in a minimalist government that allows its citizens

the freedom of choice when it comes to your own bodies.

For that reason he opposes legislation that gives the FDA more and more legal

powers to take YOUR choice away. To that end, Dr. opposes the Dietary

Supplement Safety Act of 2010 – an act that, if passed, adds dietary

supplements to food safety, thus giving the FDA broad powers to ban dietary

supplements in all forms – and to include the ability to do this under its

transforming food safety budget next year.

This bill originated with a supposedly good cause, in response to the use of

steroids by baseball players. Sponsored by Senator McCain, it’s being

sold as a necessary power the FDA needs for stopping things like steroid abuse.

The only thing is, the FDA already had that power – and it failed to do its

job! Instead, it has been concentrating on activities like regulating labels on

supplements and vitamins, so that the packages on these products cannot tell you

what good they do.

For example, the FDA has banned information about scientifically proven health

benefits of cherries from appearing on both labels and websites. It also barred

health claims about the benefits of omega-3 fats for heart, cancer, depression,

body pain, and various other conditions until a drug company pays a great deal

of money to go through the approval process. (To see an FDA list of just a few

of these charges it assesses for the “privilege†of being approved by the

FDA, go here.)

A few years ago, this agency also stopped a form of Vitamin B6, pyridoxamine,

from being sold – after a pharmaceutical company discovered that a drug it had

invented contained pyridoxamine, which had been available for years, very

cheaply over the counter.

The FDA responded to the industry pressure by banning the sale of pyridoxamine

as a supplement. As I reported in this article, the FDA defended this decision

by saying,

“To allow such an article to be marketed as a dietary supplement would not be

fair to the pharmaceutical company that brought, or intends to bring, the drug

to market.â€

So there you have it, in their own words: the FDA is looking out for its

“clients†– the people they collect user fees from – rather than for

your right to choose a naturally-occurring supplement that has been around for

years before a drug company “invented†it.

Ron ’s Message

The FDA prefaces many of its reports with its mission statement:

“The FDA is responsible for protecting the public health by assuring the

safety, efficacy, and security of human and veterinary drugs, biological

products, medical devices, our nation’s food supply, cosmetics, and products

that emit radiation.

“The FDA is also responsible for advancing the public health by helping to

speed innovations that make medicines and foods more effective, safer, and more

affordable; and helping the public get the accurate, science-based information

they need to use medicines and foods to improve their health.â€

In its own words, the FDA describes this as a “profound†mission. The only

problem is, this federal agency, perhaps more than any other, not only has let

its powers go to its head, but has relinquished some of them to the very

entities it is supposed to be monitoring.

Dr. talks about the FDA Vitamin B6 fiasco from time to time on his website.

His message about how this pertains to the current dietary supplement bill is

clear: if the bill passes, it will make it far easier for pharmaceutical

companies to file use patents on what are now inexpensive dietary supplements

and convert them into outrageously priced “drugs.â€

A prime example of this is the fish oil pill that many cardiologists prescribe

these days, Lovasa. It can cost upwards of $300 a month, depending on whether

you have insurance, and what your plan is – seven times as much as what you

pay, right now, over the counter for the same thing.

Pass the 2010 supplement bill, though – and you will see those

over-the-counter fish oil pills, as well as many others, stripped from the

shelves as the FDA’s pharma friends/clients request it.

And that is Dr. ’s message: you may not be able to stop the FDA’s new

budget from being funded, but you CAN stop the dietary supplement bill.

You can do this by contacting your state legislators, right now, today and

letting them know that the FDA has enough power to play with, and that they

should get rid of this bill while they can.

Why Does the FDA Want Something Else to Regulate?

Another key component of the FDA’s new budget is higher user fees on the

companies and industries they regulate. One of those industries is tobacco, a

group that got pushed under the FDA umbrella a year ago, when President Obama

signed into law the Smoking Prevention and Tobacco Control Act.

This, too, was a bill that, on the surface, seemed like it could only be good.

It was supposed to put the FDA in a position to monitor tobacco in such a way

that it could help prevent young people from starting smoking, and to help

adults stop.

The thing is, it was backed by the largest tobacco company of them all, Philip

. Not only that, Philip helped draft the legislation!

Outed by US Senator Mike Enzi, it turns out the tobacco giant played a key role

in outlining the FDA’s powers for this bill. And in the end, the law put

Philip at a distinct market advantage, while the FDA was loaded with

another job and not enough money to do it.

Numerous people have published protests on this PM-friendly law, such as Bill

Godshall of Smokefree Pennsylvania, who pointed out that “it protects the most

hazardous tobacco product (cigarettes) from market competition by the least

hazardous (smokefree) tobacco products.â€

In other words, this is another example of the fox helping to guard the hen

house – and another way for a big industry to have its way with the

beleaguered FDA.

But now the FDA says it can’t do this job without more money.

The only question left to ask, then, is why does the FDA need to add the

regulation of dietary supplements to its platter?

A Better Budget Would Streamline, not Inflate

In the shadow of several federal agencies releasing their budget proposals

simultaneously, something else happened recently with the FDA with very little

fanfare. On February 24, the National Institutes of Health announced that they

were partnering with the FDA on some new projects to “fast-track innovations

to the public.â€

Touting innovative medical therapies and products, FDA Commissioner Margaret

Hamburg and HHS Secretary Kathleen Sebelius said this collaborative “will go a

long way to foster access to the safest and most effective therapies for the

American people.â€

So what does this have to do with the FDA’s budget?

It’s written in that 604-page monster, with $25 million earmarked for it under

“Advancing Regulatory Science for Public Healthâ€. On page 30, the FDA

explains this funding will allow it to focus on developing tools to properly

assess the safety, effectiveness and quality of products that are being

developed or are already in the market.

Those products include both foods and medical products – and will include your

daily vitamin supplement, as well, if the Dietary Supplement Safety Act is

passed.

Aside from establishing new agencies within the FDA, such as the Office of

Science and Innovation and the Office of the Chief Scientist, which will all

mean more rent and more employees with more pay, this is just a small part of

what the new collaboration will do.

You would have to read the whole document and a lot of related materials to

understand it, but the truth is there: the FDA wants more money to create more

layers of bureaucracy.

So I ask again, just exactly how will adding more layers to an already

over-burdened agency help the FDA do a better job?

Other Agencies are Getting a Boost, Too

In a February 17, 2010 newsletter on its website, the National Institute for

Allergies and Infectious Diseases announced that it is planning on a raise, too,

through the NIH:

“At this early stage in the annual budget cycle, NIH is positioned to avoid

the budget freeze that many other agencies will likely face,†the website

says.

Then, if you take a look at the NIH budget, you will see that a number of

agencies are in line with the NIAID for budget increases. Some of this money is

to accelerate the development of new vaccines – certainly an enhancement to

the FDA’s 2011 budget plans to “fast-track†new medical devices and drugs.

The bottom line is, with the federal deficit promising to reach at least $1.27

trillion in FY 2011, President Obama has opened the doors for a select group of

government agencies to expand their budgets, rather than tightening their belts.

But overall, the FDA is getting the biggest boost to its budget in what the

President calls a budget freeze year. However, it’s highly unlikely we’ll

end up with an agency willing or capable of protecting your health in any way.

Keep Yourself Safe By You, NOT the FDA, Taking Control of Your Health!

The real solution isn't minor changes to the existing structure, but a complete

reform of the FDA. But as long as a significant portion of the FDA's budget is

being funded by the very companies they are supposedly regulating, real change

is virtually impossible.

So it’s a catch-22 that has no clear end in sight.

So, until real change takes place, please don't risk your money or your life on

a paradigm designed to profit from your ill health. Instead, switch to natural

methods that will allow your body to heal itself without the need for the deadly

drugs being pushed on you by the drug companies and the FDA.

 

Man will ultimately be governed by God or by tyrants.

Make yourselves sheep and the wolves will eat you.

Beer is living proof that God loves us and wants us to be happy.

Ben lin