FDA Wants More Money, Claims They Are a "Bargain"
May 01, 2013
By Dr. Mercola
The US Food and Drug Administration (FDA) is looking to increase their budget by $821 million next year, which would make their proposed 2014 budget a hefty $4.7 billion.
The additional money would help the FDA improve food safety, monitor imports and create measures to protect against chemical and biological threats, FDA Commissioner Margaret Hamburg told Congress, outrageously noting that:1
“FDA is a true bargain among federal agencies.”
This has to be one of the biggest delusions of the 21st century.This is one “bargain” that is not such a good deal for Americans’ health, as the FDA is also the federal agency responsible for a growing list of policy decisions that favor big industry at the expense of public health.
And if their nearly $1-billion budget increase is approved, they stand to fall even further into the drug companies’ trenches …
94 Percent of the FDA’s Budget Increase Funded by Drug Companies
Out of the extra $821 million the FDA is seeking, 94 percent, or $770 million, would come from user fees paid by the drug industry. While some of the FDA is funded by taxpayers, most of their budget comes from such user fees, which are paid by the drug companies to hasten the review and approval of their products.
Industry user fees were first introduced in the early 1990s in an effort to help speed up the FDA's approval process; prior to that, the FDA had been funded entirely by Congress.
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 user fees allow the drug industry to have major leverage over the FDA, and that control is continuing to increase year after year.
The FDA is even trying to have about $83 million in industry user fees exempted from the sequester (mandatory budget cuts to federal agencies that began in 2013), as these fees are supposed to be withheld due to the sequestration. Yet, with a budget already surpassing the $4-billion mark, the FDA has done little to keep Americans safe from dangerous foods and drugs. Instead, they:
- Quietly withdrew their intent to ban low-dose antibiotics in animal feed, allowing the spread of antibiotic-resistant “super-germs” linked to this practice to continue unabated
- Approved the first genetically modified plant intended for the treatment of a human disease, opening the door for biotech companies such as Monsanto, which also has vested interests in the pharmaceutical industry, to design more drugs created from genetically engineered plants and/or animals
- Is considering allowing the unlabeled use of the artificial sweetener aspartame in dairy products
- Approved a generic version of Actos – the brand name for a drug used to treat type 2 diabetes – even though it is presently embroiled in thousands of lawsuits alleging that the drug causes severe side effects including heart failure, macular edema and bladder cancer
- Attempting to regulate stem cell procedures at a Colorado clinic, even though the stem cells being used in the procedure come from the patient’s own body, which means they are essentially claiming that they can regulate a part of your body
FDA Allows Drugs to Remain on Market Despite Uncovering Fraudulent Safety Data
What do you get when the federal agency in charge of monitoring drug safety is funded largely by the companies producing those very same drugs? A massive conflict of interest and an agency that is more interested in serving the drug industry than the American public.
This is not speculation; it’s been shown to be the truth, time and time again. In 2011, the FDA found out that many studies conducted at Cetero Research, a major drug research lab, from 2005 to 2009 were fraudulent, involving manipulated data and tampered records.2 About 100 drugs were already on the market, approved, at least in part, based on these fraudulent studies.
Yet, the FDA made no warnings to the public, instead allowing the potentially dangerous drugs to remain on the market while it quietly ordered re-testing to be done. In Europe, however, multiple drugs were pulled from the market following the revelation. Even today, the FDA has never released a list of the affected drugs, saying this would reveal trade secrets.
Unfortunately, this wasn’t an isolated case. As Scientific American and ProPublica reported:3
“Turns out that wasn't an anomaly: The agency's slow, secretive response in the Cetero case mirrors how it handled an earlier instance of scientific misconduct at another contract research organization, MDS Pharma Services.”
When the FDA found that four years’ worth of data produced by two MDS facilities were potentially fraudulent, it again refused to post a public list of the 217 affected drugs, some of which were already being sold. Despite requiring re-testing of many of the medications, the FDA assured the public that the drugs were safe – an impossible truth since they were approved, in part, based on faulty research. At least five of MDS’ senior executives later went to work for Cetero Research.
Scientific American continued:4
“In January 2007, three and a half years after first finding problems at MDS, the FDA informed drug makers that studies done by MDS between 2000 and 2004 needed to be reevaluated. FDA officials told the media that 217 generic drugs were potentially implicated, 140 of which were already approved for sale.
The agency was unsure how many new drugs might have relied on studies carried out by MDS, according to news accounts, so it asked the manufacturers of every new drug approved between 2000 and 2004 -- some 900 medicines -- to check to see if MDS had conducted any relevant tests. 2The FDA made no effort to warn doctors or patients that it now had doubts about the data underlying some of the drugs it had approved. Instead, the agency sounded a public 'all clear.'”
The FDA Is Failing at Its Stated Mission
Now, with the FDA requesting even more money from the drug industry, it’s likely that such egregious biases in favor of the industry are only going to continue. They simply cannot risk biting the proverbial hand that feeds them …The FDA's mission statement reads as follows:
"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 2007, a report bearing the revealing title "FDA Science and Mission at Risk" by the Subcommittee on Science and Technology,5 detailed how the FDA cannot fulfill its stated mission because:
- Its scientific base has eroded and its scientific organizational structure is weak
- Its scientific workforce does not have sufficient capacity and capability, and
- Its information technology (IT) infrastructure is inadequate
Furthermore, the report found that "the development of medical products based on 'new science' cannot be adequately regulated by the FDA, and that the agency does not have the capacity to carry out risk assessment and analysis. Additionally, the agency's science agenda "lacks coherent structure and vision, as well as effective coordination and prioritization."
The fact that the FDA does not have its ducks in a row, so to speak, has sorely misplaced its priorities, and is not working to fulfill its mission is clearly evidenced in the numerous cases where hundreds and sometimes thousands of complaints about dangerous drugs (like Vioxx and Avandia), vaccines (like Gardasil), and additives (like aspartame) are stubbornly ignored, while SWAT-style teams armed to the teeth are sent to raid supplement makers, whole food businesses, organic farmers, and raw dairies when oftentimes not a single incidence of harm can be attributed to their products.
Hospitals Make More Money From Surgical Complications
The FDA has little incentive to change its current structure or work harder to uncover drug dangers, lest they put billions of dollars of their funding at risk. Likewise, a revealing new JAMA study found that major surgical complications actually earn hospitals more money on privately insured or Medicare-covered patients.6
This isn’t exactly shocking, of course, since the more complications suffered, the longer the hospital stay and the more associated medications, tests and procedures that will be ordered. Hospitals are a business, after all, and the more “services” used by any one patient, the more money they make.
Where money is concerned, a hospital therefore has no incentive to reduce surgical errors and other medical mishaps, which may actually be a key moneymaker for them. And, as the Health Business Blog astutely reported,7 unlike most businesses, which suffer financially when mistakes occur, hospitals get to charge you even more money to treat you for avoidable complications or mistakes they make. Decreasing surgical complications may therefore have adverse financial consequences for many hospitals, the researchers concluded.
More Reason to Take Control of Your Health
Minor changes to the existing structure will not be enough to change the current medical paradigm, which is designed to profit from your ill health. A complete reform of the system would instead be needed, and there are powerful forces at play that do not want this to happen.
As much as possible, be proactive in using a healthy lifestyle to support and protect your health and, if illness does occur, use 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.