The Politics and Economics of FDA Drug Approval
The United Sates Food and Drug Administration has been protecting American consumers for around 70 years. The FDA assures the safety drugs, medical devices, chemicals, cosmetics, foods and additives by evaluating products for approval. Controversy has recently been surrounding the FDA's drug approval process, due to a general trend to get pharmaceuticals on the market more quickly. The FDA has been under pressure from congress and the public to speed approval, but pharmaceutical companies, who benefit more than anyone form accelerated drug approval, have also been applying pressure to the FDA through congress. The speeding of the approval process helps patients with incurable illnesses receive experimental drugs, but some wonder if the FDA is weakening its safeguards in the process. Since the passing of the Modernization Act last year, people have become concerned with the safety of dietary supplements and 'off-label' uses for drugs. In the past year, drugs have been approved at an unprecedented rate, but they also have been withdrawn from the market more frequently. The recent growth in the popularity of dietary supplements has caused many to worry about their safety. Thus, there remains the question if the FDA is still adequately protecting us from dangerous drugs.
The Food and Drug Administration began in the U.S. in 1927 as a separate law enforcement agency and now employs over 9,000 workers spread over 157 cities (The Food and Drug Administration: An Overview 1). Four laws dictate the power of the FDA. The Federal Food, Drug and Cosmetic Act established purity standards and introduced the requirement of factory inspection. The FDA's authority to require honest in...
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...A Modernization Act of 1997. 21 Nov. 1997. 24
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Dr. John Abramson’s book Overdosed America debunks the myths about the excellence of American medicine. Abramson backs up this claim by closely examining research about medicine, closely examining the unpublished details submitted by drug manufacturers to the FDA, and discovering that the unpublished data does not coincide with the claims made about the safety and effectiveness of commonly used medicines. Abramsons purpose is to point out the flaws of the pharmaceutical industry in order to warn the readers about the credibility of the drugs they are buying. Given the critical yet technical language of the book, Abramson is writing to an audience that may include academic physicians as well as those who want to learn about the corruption of the pharmaceutical industry.
government set forth the Food and Drugs Act of 1906 in response which regulated and
"In the past two decades or so, health care has been commercialized as never before, and professionalism in medicine seems to be giving way to entrepreneurialism," commented Arnold S. Relman, professor of medicine and social medicine at Harvard Medical School (Wekesser 66). This statement may have a great deal of bearing on reality. The tangled knot of insurers, physicians, drug companies, and hospitals that we call our health system are not as unselfish and focused on the patients' needs as people would like to think. Pharmaceutical companies are particularly ruthless, many of them spending millions of dollars per year to convince doctors to prescribe their drugs and to convince consumers that their specific brand of drug is needed in order to cure their ailments. For instance, they may present symptoms that are perfectly harmless, and lead potential citizens to believe that, because of these symptoms, they are "sick" and in need of medication. In some instances, the pharmaceutical industry in the United States misleads both the public and medical professionals by participating in acts of both deceptive marketing practices and bribery, and therefore does not act within the best interests of the consumers.
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The momentum generated by the passage of the Meat Inspection Act helped secure the passage of the Pure Food and Drug Act, which had been stalled in Congress since 1905. With these two pieces of legislation, the federal government took important steps to assure the public that the food they were eating met minimu...
To begin, the Federal Food and Drug Administration does not have the power to regulate supplements like it does with drugs. Once a product is out on the market, the FDA has to prove that it is dangerous or has illegal additives before it can be removed. The FDA has targeted around seventy tainted weight loss products after learning that they had been mixed with undeclared stimulants, diuretics, and antidepressants (Trebilcock 2). The Federal Food, and Drug, Administration is responsible for ensuring that the manufacturers of foods provide safe ingredients and the correct amount of dosages for their products.
Grabowski, Henry and John Vernon. 1986. “Longer Patents For Lower Imitation Barriers: The 1984 Drug Act”, The American Economic Review. Pages 196-198.
Every year approximately 200,000 souls die from prescription drug reactions, with another 80,000 dying from medical malpractice (The International). Where is the FDA based? Why do they continue to allow doctors to prescribe these drugs? How could they get to this point? What once was believed to be a panacia for depression has turned into Pandora's box (Tracy).
"Regulatory Information." Federal Food and Drugs Act of 1906. U.S. Food and Drug Administration, 20 May 2009. Web. 14 Apr. 2014. .
In the business of drug production over the years, there have been astronomical gains in the technology of pharmaceutical drugs. More and more drugs are being made for diseases and viruses each day, and there are many more drugs still undergoing research and testing. These "miracle" drugs are expensive, however, and many Americans cannot afford these prices.
“About 150 million people in the US use dietary supplements; about 79% use it on a daily bases, and 10% taking 5 or more per day” (Ranjani 478). Dietary supplements range from sports performance products, weight loss products, to a variety of herbal remedies. These supplements are used widely to help maintain or improve the health of the human body. While buying these products many assume that they are regulated and are safe for human consumption, however it may not be the case. “Supplements face no FDA requirements for premarket testing. Supplements can be placed on the market at the will of the makers and then remain legal for sale” (Quinones 32). Dietary supplements should be regulated like prescription drugs because it’s a safety hazard, can become addictive, and may lead to dangerous health problems.
Martinez, Barbara “Firms Paid to Trim Drug Costs Also Toil for Drug Makers” The Wall Street
FDAs public health protection duties. By ensuring that products and producers meet certain standards, FDA protects consumers and enables them to know what they are
In Lee Ann Fisher Baron’s “Junk Science,” she claims that the “food industry with the help of federal regulators” sometimes use “[a science that] bypasses [the] system of peer review. Presented directly to the public by…‘experts’ or ‘activists,’ often with little or no supporting evidence, this ‘junk science’ undermines the ability…[for] everyday consumers to make rational decisions” (921). Yet Americans still have a lot of faith in the U.S. Food and Drug Administration (FDA). According to a 2013 Pew Research study, 65% of Americans are “very favorable” or “mostly favorable” of the FDA. When it comes to what people put in their bodies, the FDA has a moral obligation to be truthful and transparent. The bottom line of the FDA’s myriad of responsibilities is to help protect the health of Americans. Deciding what to eat is a critical part of living healthily, and consumers must be able to trust that this massive government agency is informing them properly of the contents of food. While the FDA does an excellent job in many areas, it has flaws in other areas. One of its flaws is allowing the food industry to print food labels that are deceptive, unclear, or simply not true (known as misbranding). This is quite the hot topic because a Google search for “Should I trust food labels” returns well over 20 million results, many of which are blog posts from online writers begging their readers not to trust food labels. HowStuffWorks, a division of Discovery Communications, published an online article whose author claims that “[the food industry] will put what they want on labels. They know the game….” While the food industry is partially at blame for misbranding, the FDA is allowing it to happen. If a mother tells her children that it is oka...
Ever since human beings have walked this earth they have been eating food and preparing meals. There really is no exact date as to when man first began to cook their meals but whenever that revelation occurred it would change the way humans look at food forever. Now let us fast forward a few hundred thousand years to the 21st century, these days food safety has become a huge priority at the national level. Many programs and departments have been created to bring the public’s attention to this issue. The most notable agency in regards to food safety is the Food and Drug Administration (FDA). The FDA is responsible for protecting the overall public health of American citizens by regulating foods, among others. More specifically the FDA oversees almost everything we put into our bodies, legally that is. The FDA is responsible for recalling contaminated food, regulating dietary labels, etc . So how does this agency pertain to food safety in the home? The answer is quite simple; virtually everything that the average American will eat for dinner has most likely been regulated by this agency. They are responsible for protecting what we put into our bodies, whether we want to admit it or not, we are trus...