Troubled times at the FDA

April 24, 2008  |  General

The FDA (Food and Drug Administration) has been battered with another serious incident, this one involving bad batches of the drug heparin (a blood thinner) that originated in China. Nearly a hundred people have died and many others experienced serious reactions after receiving heparin which appears to have been deliberately adulterated with a dangerous (and much cheaper) chemical. Until I read about it I had no idea such a large proportion of our drug manufacturing, like our clothes and our children’s toys, has been outsourced, primarily to China. In fact, now over 80% of the medicines you take, or at least the major ingredients in them, come from abroad. How can we be sure those medicines are safe?

As it turns out, we cannot — assuring the safety of these products is nigh impossible. The FDA is charged with inspecting all factories that make drugs. This was at least manageable when these facilities were in the USA, although staffing cutbacks at the FDA have even made this very difficult. In the case of foreign sites, it is unclear where some of these factories even are, and there are four times as many of them as there were 25 years ago. You can read a good discussion of the FDA’s woes here.

What to do? As one knowlegable person has pointed out, playing “kick the FDA” is not the answer. At its current level of funding, the agency will never have enough inspectors to scour the globe inspecting all these facilities. Increasing this surveilance will cost money. Where should that money come from? Drug manufacturers have reaped the financial benefit of outsourcing — I think it is time they either shoulder a major share of insuring the safety of our medicines, or else bring the manufacturing process back to this county where at least it will be easier to monitor. The recent heparin tragedy shows us what can happen if we do not do this.


1 Comment


  1. The Conversion of Our Protector

    Not long ago, what we as American citizens ingested in ourselves may have been at times dangerous due to flaws in the process of producing food and drugs in particular. With the absence of regulation of the manufacturers, American citizens could not be assured in what they may take to eat or restore their health was safe for them, and this was understandably concerning for many people.
    Nearly 100 years ago, one man changed the fears and concerns of American Citizens regarding what they may eat, or what medicine they may be given to restore their health. And this man simply improved the way things were by writing a book.
    The Food and Drug Administration originated in its primitive form several decades ago to ensure the health and safety of the citizens of the United States in regards to what they consume. The administration was created to regulate the manufacturers who make items people do consume to ensure the safety of the American citizens.
    The man responsible for the development of the Food and Drug Administration was a socialist named Upton Sinclair, who was a writer. One particular book he wrote several decades ago, while fictional, addressed the working conditions in a meat packaging company that were quite shockingly described by Upton in this book. Called, “The Jungle” The one particular issue in his book regarding the lack of food safety is what caught the attention of the public who read his book, and this included the U.S. president. The impact caused by this book on others is what led to the development of the FDA.
    However, and with great disappointment, the purpose and function of the FDA seems to have changed in the past few decades. The FDA appears to have decided to ensure the health of the pharmaceutical industry, an industry the FDA was designed to regulate. This is one of many disturbing flaws and concerns expressed by others regarding the FDA.
    One example is the large amounts of money the pharmaceutical industry gives the FDA for various reasons created recently. These amounts of money are so large that this money given to the FDA accounts for nearly half of the FDA’s entire budget. An example of stated reason by the FDA for receiving such funds is due to what is known as the PDUFA ( the prescription drug user fee act), which began in 1992. Basically, the drug industry has been authorized and is now required to pay the FDA for faster approval of their medications awaiting approval by the FDA. The FDA also accepts from this industry over a million dollars from certain drug companies in order to give their pending new drugs a priority review of 6 months instead of a year, along with a creating an etiology for this urgency as it happens, others have said.
    Results of this relationship, which some have called collusive and pathologically intimate between the FDA and the drug industry, may have something to do with the actual removal of newly approved drugs due to safety reasons. The lack of regulation and monitoring required by the FDA of the pharmaceutical industry has resulted in such dangerous safety concerns, one could safely say.
    The FDA and the drug industry continues to attempt to validate and explain often what many others have questioned about the FDA and its lack of focus on the safety of the public- the public the FDA is suppose to protect to assure their safety. Yet the focus of the FDA and the purpose of their creation appears to be absent.
    The presumed intimacy between these two organizations, the pharmaceutical industry and the FDA, does in fact seem to continue to worsen. For example, and recently, the FDA announced they were allowing the pharmaceutical industry to allow their promoters of their branded drugs they market to discuss these products for disease states not studied or evaluated by the FDA. This process use to be mandatory before a drug company could claim that their drugs were beneficial for a particular disease state. Many remained shocked on this decision made by the FDA.
    Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative of the marketer of a particular medication, which remarkably mirrors the premise and objective of this industry already. So this strategy, void of any protection of the public health, allows for potential dangers associated with this practice. This autonomy of the FDA illustrates once again the present state of the FDA and its need for reform.
    A prescriber, upon their own discretion, can in fact prescribe a drug off-label, and they do so based upon their own discretion. Historically, a pharmaceutical drug promoter was legally forbidden to suggest to a health care provider to use their promoted drugs for disease states not approved by the FDA already.
    In fact, it was a federal offense for such drug representatives to speak off-label about the drugs they promoted for their employers. In the past, drug companies have had to pay settlements to the DOJ when they fractured these laws regarding off label promotion of medications.
    This off-label FDA protocol for drug representatives that has been allowed by our FDA with presumed encouragement by the pharmaceutical industry is called, “Good Reprint Practices.” This overt and absurd benefit for the pharmaceutical industry is that now they can have their pharmaceutical sales representatives, unregulated themselves, speak about their promoted medications to health care providers essentially in any way they choose.
    Furthermore, this proposal is flawed in that most pharmaceutical representatives lack necessary medical and clinical training to discuss the complex considerations a health care provider is able to do because of their training.
    Most drug representatives have little medical or clinical training in any objective way, and they are not hired with having such a background, usually. So this seems to further complicate the idea of this off-label authorization by the FDA due to the ignorance of the representatives to discuss such clinical matters. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for representatives of the pharmaceutical industry to further embellish statements to prescribers for their own benefit in regards to their promoted medications they present to them. In fact recently, a study by Sermo concluded that 90 percent of doctors want clinical evidence based medicine from educated and trained professionals instead of the typical pharmaceutical sales representatives that now exist. This study also concluded that around 80 percent of health care providers prefer not to interact with pharmaceutical representatives, yet still accept drug samples from them for their patients. The results are rather understandable considering what we now know.
    So, our previous safety association, the FDA, appears to be evolving into a possibly harmful association with the pharmaceutical industry by suggesting such practices that aggravate the existing situation with the lack of protection that was once offered and required from the FDA.
    It is unbelievable this good reprint practices ever came into existence- with the delusional fallacy that it would be of any benefit to patient health. Furthermore, this may complicate if not increase existing patient medication errors, such as in the elderly or dosing for children.
    So there are enough problems with prescribing, and adding this FDA seems to be making the issues with medications in the U.S. worse instead of better. We as citizens are no longer the concern of the FDA, one could safely conclude, and this is clearly dangerous to the health of the public.
    Perhaps another alternative would be to have clinically trained people discuss such issues regarding the benefits of medications with prescribers, instead of existing drug reps who have the sole objective of increasing the market share of their promoted meds with no regard to the science behind these meds, in large part, or the consequences of their actions as they promote their drugs in this way. Because historically, medications have in fact proven to be beneficial for other disease states other than what a certain drug was initially indicated for upon approval. Yet this should not be determined by those who promote such drugs. Now, unfortunately, pharmaceutical representatives are allowed to determine how they can promote their drugs for their employer’s benefit.
    Regardless, awareness needs to happen by the citizens involving these tactics progressively allowed by the FDA that are dangerous and deceptive to the health of the public. As citizens, we have the right to insist that the FDA- our FDA- maintains focus on the safety of the public and their health. Reform of the FDA appears to be necessary for this to occur to re-establish the FDA as the administration that was created for our protection, and not to protect others financially.
    About half of all drugs approved presently by the FDA have had serious post-approval side effects that should have already been known or suspected of these drugs. Well over 100 thousand people die every year from drug reactions or mistakes. This seems to be a rather significant concern for those who are need to restore their health.
    Dan Abshear

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