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.
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.
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, GlaxoSmithKline, and others, as clients, John Jenkins, one of the FDA’s deputies, flippantly said, “I think it’s quite silly to bring that up as a point.”
What is the Point, Then?
The point is, the FDA just doesn’t “get it”. 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.”
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 “safe” 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. David 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 Paul is the constitutionalist Congressman that I interviewed just a few weeks ago. Dr. Paul 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. Paul 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 John 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.”
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 Paul’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.”
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. Paul 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.”
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. Paul’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 Morris. Not only that, Philip Morris 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 Morris 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.”
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.”
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.”
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 Health”. 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.