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Legalized Bribery Alive And Well In Washington As Congress Reapproves FDA User Fees For Drug Companies

Despite the howls of protest about the evils of regulation that constantly emanate from multination corporations and their mouthpieces, in most cases the regulatory agencies of the federal government actually have a very cozy and incestuous relationship with the industries they have been assigned to monitor. This “you scratch my back and I’ll scratch yours” quid pro quo system clearly benefits both sides, as corporations and other powerful economic actors are largely given carte blanche to dictate how the rules will be written, while government bureaucrats know that once they leave government, they will always have plush jobs waiting for them with the companies they are supposedly regulating, as long as they go along with the program and don’t make waves. Small business owners, small farmers, and other individual contractors may find government regulations stifling, arbitrary, and frustrating, but what many fail to understand is that the system has been intentionally designed to work this way. Government bureaucracies exist to protect entrenched interests from competition, not to protect the interests of the public as they so often claim, and the rules they create are intended to preserve the status quo and protect the privileged positions of wealthy, powerful elites.

Trying to select the most dishonest and disreputable United States government agency would be a daunting task indeed. But the Food and Drug Administration would have to be considered a strong contender for that dubious distinction. Allegedly created to make sure the foods we eat and the drugs we take are safe, the FDA long ago abandoned its mission in order to more effectively promote the interests of agribusiness and the pharmaceutical companies. While some – but not all – of the scientists who work for the organization are honest, the bureaucrats who make the final decisions at the FDA are mostly concerned with protecting the profit margins of the industries they are allegedly regulating. As a result of this corruption, the food companies are left free to inundate the market place with nutritionally empty, additive-laden, overly processed junk food. Even more egregiously, the pharmaceutical companies are given a free hand to sell drugs whose side effects lead to the premature deaths of over 100,000 Americans each year.

But remember, this is a quid pro quo relationship we are talking about here, and in return for their cooperation the FDA requires the drug companies, along with the manufacturers of medical devices, to pay what are referred to as “user fees.” Ostensibly, these fees are paid to cover the costs of the testing and review process that the FDA must undertake before allowing any new drug to enter the marketplace, but critics charge these payments are little more than a form of legalized bribery that all but guarantees a favorable response every time a pharmaceutical company submits a new product for review. Given how frequently pharmaceuticals granted FDA approval end up being recalled because of the high number of deaths and permanent injuries they cause, this view would appear to have some basis in fact. At this point, the FDA’s oversight of the drug industry is essentially a joke.

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The legislation that established these rates was due to expire in September of this year, but thanks to Congress, that problem has now been eliminated. On May 24, by a vote of 96-1, the Senate passed the Food and Drug Administration Safety and Innovation Act, which reauthorized the user fee system for another five years. The House of Representatives wasted little time in adding their imprimatur to the FDA’s profitable racket, passing the Food and Drug Administration Reform Act (different name, same idea) just one week later by an overwhelming 389-5 margin. Some negotiations will be necessary to resolve the differences between the two reauthorization bills, but these talks are expected to be little more than a formality, and the hope is that the final version of this legislation will be on President Obama’s desk by sometime in July (his signature is also considered a formality).

Veteran Capitol Hill observers expressed surprise at the near-unanimous support reauthorization received in both congressional chambers, but this is testimony to the absolute control the pharmaceutical industry has managed to gain over both political parties. While it may seem surprising, given the fact that the user fees system costs them money, passage of this bill was considered the number one legislative priority for the drug companies in 2012, and when you spend tens of millions of dollars annually on lobbying and on funding political action committees the way the pharmaceutical industry does, you can be pretty sure that your top concerns will be addressed post haste. Even though it is costing them, Big Pharma probably sees it as a smart and prudent investment.  Now with the smaller pharmaceutical companies, it is a different story – most of them are staunchly opposed to the user fees, which they claim are little more than a shakedown they can ill afford to pay. But remember, government bureaucracies are there to protect the biggest, most entrenched players in the game against upstarts, so this aspect of the user fee system is hardly accidental.

Interestingly, before final passage there were some amendments offered on the Senate floor that would have changed its version of the reauthorization bill substantially. The most hotly debated of these amendments, introduced by John McCain (R-AZ), would have made it much easier for Americans to have their drug prescriptions filled online through reputable Canadian pharmacies. Since many prescription drugs can be purchased cheaply outside the United States, such a move could potentially cut down on the profits of the drug companies significantly, which is why they opposed this idea so vociferously. While the Senate debate was spirited, as McCain himself predicted the power of the pharmaceutical companies was too strong to resist in the end, and the proposal went down to defeat by a vote of 54-43.

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Another worthy amendment opposed by the drug giants was also defeated. Bernie Sanders (I-VT), who was the lone dissenter in the final 96-1 vote, wanted to add a clause that would have stripped exclusive marketing rights to particular drugs from any pharmaceutical company found guilty of fraud in connection with the sale of those drugs. This problem is not insubstantial; in 2012, pharmaceutical companies are expected to pay out over $9 billion in penalties as a result of fraud judgments, being found guilty of such acts as price fixing, suppressing negative research findings, cheating Medicaid and Medicare by over-billing, and marketing drugs for conditions they had not been approved to treat. But despite this industry’s sad and sorry history of misconduct, only nine senators voted in favor of the Sanders Amendment, while eighty-eight others voted against the idea of holding the drug companies more responsible for their dishonest and unethical behavior.

One good amendment was proposed by Rand Paul (R-KY), who wanted to disarm FDA agents and stop their raids against raw milk producers accused of violating FDA rules by selling their products directly to consumers. Paul’s amendment would also have stopped the FDA’s vendetta against the herbal medicine/nutritional supplement industry by stripping the agency of its ability to arbitrarily censor information about the health benefits of products sold by supplement retailers and manufacturers. Regrettably, this attempt to limit the power of a rogue government bureaucracy was voted down 78-15, and as a result, FDA agents will still be left free to storm onto private property with guns drawn any time they choose—especially if they believe someone is committing the horrible crime of selling milk that has not yet had its nutritional value completely destroyed by pasteurization. Additionally, the organization will still be able to continue its campaign of slander and insinuation against natural supplements and herbal medicines, which contain ingredients that people have been using to treat disease and illness for thousands of years all across the world. But if the masses started curing their ailments with natural products, they would obviously have no more need for pharmaceuticals, and this is a scenario the FDA would like to avoid at all costs.

Fortunately, one anti-supplement amendment that was supported by the pharmaceutical industry was defeated. Richard Durbin (D-IL), a perpetual thorn in the side of the natural health movement, wanted to change registration and labeling requirements for supplement suppliers so that they would be forced to pull their products from the market if they couldn’t meet new stringent reporting rules within a thirty-day period. Since the sellers and manufacturers of these products already have to register them and fully disclose their contents to customers, there was really very little rationale for making this kind of change. Natural health advocates organized a last-minute campaign designed to flood senate offices with phone calls, letters, and emails denouncing the Durbin Amendment, and perhaps in response to the public outcry, the Senate ultimately rejected this thinly veiled attack on the natural products industry by a resounding 77-20 margin.

When the Fox Guards the Henhouse

The user fee system is a clear example of how things work when government agencies do the bidding of powerful private interests. At first consideration, it might seem as if the FDA is simply taking a cut out of the profit margins of the drug companies in order to fund studies that will guarantee that dangerous drugs don’t inadvertently reach the market. But what is actually happening is that pharmaceutical companies are paying protection money to make sure the FDA does not start putting the safety of the public before the needs of their industry. This arrangement is profitable for both sides, and that is why both sides are so interested in seeing the status quo preserved without amendment or alteration.

©2012 Off the Grid News

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