• Embed Doc
  • Copy Link
  • Readcast
  • Collections
  • CommentGo Back
Download
 
 The Conversion of Our ProtectorNot long ago, what we as American citizens ingested in ourselves may have been attimes dangerous due to flaws in the process of producing food and drugs inparticular. With the absence of regulation of the manufacturers, American citizenscould not be assured in what they may take to eat or restore their health was safefor them, and this was understandably concerning for many people.Nearly 100 years ago, one man changed the fears and concerns of AmericanCitizens regarding what they may eat, or what medicine they may be given torestore their health. And this man simply improved the way things were by writinga book. The Food and Drug Administration originated in its primitive form several decadesago to ensure the health and safety of the citizens of the United States in regards towhat they consume. The administration was created to regulate the manufacturerswho 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 wasa socialist named Upton Sinclair, who was a writer. One particular book he wroteseveral decades ago, while fictional, addressed the working conditions in a meatpackaging 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 caughtthe 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 theFDA.However, and with great disappointment, the purpose and function of the FDAseems to have changed in the past few decades. The FDA appears to have decidedto ensure the health of the pharmaceutical industry, an industry the FDA wasdesigned to regulate. This is one of many disturbing flaws and concerns expressedby others regarding the FDA.
 
One example is the large amounts of money the pharmaceutical industry gives theFDA for various reasons created recently. These amounts of money are so largethat this money given to the FDA accounts for nearly half of the FDA’s entirebudget.An example of stated reason by the FDA for receiving such funds is due to what isknown 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 FDAfor faster approval of their medications awaiting approval by the FDA. The FDA also accepts from this industry over a million dollars from certain drugcompanies in order to give their pending new drugs a priority review of 6 monthsinstead 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 pathologicallyintimate between the FDA and the drug industry, may have something to do withthe actual removal of newly approved drugs due to safety reasons. The lack of regulation and monitoring required by the FDA of the pharmaceutical industry hasresulted in such dangerous safety concerns, one could safely say. The FDA and the drug industry continues to attempt to validate and explain oftenwhat many others have questioned about the FDA and its lack of focus on the safetyof the public- the public the FDA is suppose to protect to assure their safety. Yet thefocus of the FDA and the purpose of their creation seems to be absent. The presumed intimacy between these two organizations, the pharmaceuticalindustry and the FDA, does in fact seem to continue to worsen. For example, andrecently, the FDA announced they were allowing the pharmaceutical industry toallow their promoters of their branded drugs they market to discuss these productsfor disease states not studied or evaluated by the FDA. This process use to be mandatory before a drug company could claim that theirdrugs were beneficial for a particular disease state. Many remained shocked onthis decision made by the FDA. Yet the FDA claims that this proposal would enhance the education and knowledgeof the prescriber by the pharmaceutical representative of the marketer of a
 
particular medication, which remarkably mirrors the premise and objective of thisindustry already.So this strategy, void of any protection of the public health, allows for potentialdangers associated with this practice. This autonomy of the FDA illustrates onceagain 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, andthey do so based upon their own discretion. Historically, a pharmaceutical drugpromoter was legally forbidden to suggest to a health care provider to use theirpromoted drugs for disease states not approved by the FDA already.In fact, it was a federal offense for such drug representatives to speak off-labelabout the drugs they promoted for their employers. In the past, drug companieshave had to pay settlements to the DOJ when they fractured these laws regardingoff label promotion of medications. This off-label FDA protocol for drug representatives that has been allowed by ourFDA with presumed encouragement by the pharmaceutical industry is called, “GoodReprint Practices.” This overt and absurd benefit for the pharmaceutical industry isthat now they can have their pharmaceutical sales representatives, unregulatedthemselves, speak about their promoted medications to health care providersessentially in any way they choose.Furthermore, this proposal is flawed in that most pharmaceutical representativeslack necessary medical and clinical training to discuss the complex considerations ahealth care provider is able to do because of their training.Most drug representatives have little medical or clinical training in any objectiveway, and they are not hired with having such a background, usually. So this seemsto further complicate the idea of this off-label authorization by the FDA due to theignorance of the representatives to discuss such clinical matters.In addition, the relaxation of previous restrictions regarding off-label promotioncould prove to be a catalyst for representatives of the pharmaceutical industry to
of 00

Leave a Comment

You must be to leave a comment.
Submit
Characters: ...
You must be to leave a comment.
Submit
Characters: ...