The Case of the Adulterated, Misbranded or False Claimed Drug
Perusing warning letters in FDA’s Electronic Reading Room yields a plethora of violations regarding adulterated, misbranded or falsely claimed benefits of drugs and supplements. These three issues, consequently, constitute stumbling blocks in drug development or approval and additionally, perhaps also indicate a wanton disregard of compliance in manufacturing and marketing. Do the responsible companies prioritize compliant procedures and documentation? Through investigating three of the most commonly cited reasons for FDA 483 letters, applying them to the above violations, and exploring a culture of compliance, some rationale for causes in this case may be determined.
Insufficient procedures and the adulterated drug
According to compliance-insight.com, the primary cause for an FDA 483 letter is “procedures not in writing, fully followed, 21 CFR 211.22(d)” (Top 10 Reasons for FDA 483). The necessity for well documented and detailed procedures
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The temptation to engage in exaggeration always exists, but taking unacceptable risks affecting people’s health will get a company in big trouble, as “SOPs not followed / documented, 21 CFR 211.100(b)” rounds out the top ten for precipitating FDA 483 letters (Top).
Company culture of compliance
The above compliance failures illustrate the importance of maintaining a compliant company culture. Managers must create and participate in a top down culture of compliance to succeed. Attempting to change an established noncompliant culture encourages employee resistance and unfortunately often meets with failure. Companies must get this right from the start, or suffer many negative and serious consequences, including the complete withdrawal of substances from FDA
Compliance is pertaining to the adherence to laws and regulations that the company is subject. Raven Head Ranch did not follow this objective when they were writing checks approved by the same person and putting them in unapproved projects, for example the Volunteer Fire Department. The VFD had been receiving funds from misappropriate accounts for three years. Fifty individual disbursements were taken from the community checking account and had no proper recording, just charged to random accounts, which breaks the regulations and laws of proper accounting. One of the BoD members, Sam, was not even a resident of RHR and was on board supervising the employees with no legal right
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.
The FDA was given the authority to approve pharmaceutical products for marketing in the U.S. as a result of the Federal Food, Drug, and Cosmetic Act, passed in 1938 (FDA par 2). In 1960’s, the agency issued final regulations for prescription drug advertising, which stipulated that these ads must not be false or misleading, present a “fair balance” of information describing both the risks and benefits of a drug, include facts that are “material” to the product’s advertised uses, and include a “brief summary” that mentions every risk described in the product’s ...
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. In America today, many people are in need of medical help. In fact,the Federal Trade Commission estimates that 75% of the population complain of physical problems (Federal Trade Commission 9). They complain, for example, of fatigue, colds, headaches, and countless other "ailments." When these symptoms strike, 65% purchase over-the-counter, or OTC, drugs.
FTC requires the manufacturer must provide all ingredients, their quantity, and their significant relationship with the health condition. They must scientific proof, reliable evidence to support their claim. The product has to be clinically tested on humans. It has to be undergone through various placebo controlled and experimental group. Finally the data is collected and conclusion is made based on numerous evidence and support. After that the theory has to be reviewed by experts in the same field to be granted as a scientific proof. US food and drug administration board permits some claims on the product label, with some restrictions. There are four general categories of claims made. Firstly, health claims, which have numerous study and evidences to support them. Secondly, Preliminary claims like on phytochemicals, which have some evidences but no proper research ha...
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.
Relatively recently in history the development of specialized, or problem-oriented, courts have assumed a predominate role in multiple areas. Three of the major ones discussed here include drug, mental health, and domestic violence courts. In 1996, the American Bar Association provided their interpretation of specialization, stating:
both the benefit and risk of all medication before approval.. In addition, FDA makes the labeling
Inside most packaging all prescription medication from a pharmacy are instructions and disclaimers for the product; these instructions includes a list of prescriptions that conflict with the medication, side effects of the drug itself, allergic reactions, phone numbers to call if the drugs affect you badly, emergency methods to prevent death and information on the statistics included in the drug testing and chemical analysis. Unfortunately many people never read ...
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...
“Our goal is to be the number 1 stock on Wall Street, and revenue growth is the key to increasing the company’s market value”, say Bernie Ebbers, the founder and CEO of WorldCom. Obviously, WorldCom is focus on market value and revenue. It’s not surprising the corporate culture supported rule-breaking and extreme risk taking to meet the Wall Street’s expectations. When the senior executives are working on maximizing the market value, the employees of the lower level will follow, especially in a corporation with strict hierarchy, since the orders are passed from the top to the bottom. Even though the lower level employees may refuse to follow, are they able to overturn all the levels and thus change the existing culture?
In today’s world, pharmaceutical companies are driven by huge profit making instead of making novel drugs that can cure diseases. After the legalization of direct- to direct consumer advertisement in the USA in 1980, Big Pharma took this opportunity to quickly reach out for consumers and products promotion (Jain, 2014). This results into increase dissemination of false information regarding pharmaceutical products such prescription drugs. In 2004, Merck for example was forced to withdraw its blockbuster pain relieve drug Vioxx from the market because of the serious adverse effects such as heart problems and ulcers as compared to traditional non-steroidal anti-inflammatory drugs (NSAIDs) such ibuprofen, aspirin and prescription naproxen (Jain, 2014). According to
Webster, John. "Drug Marketers Don't Always Deliver a Healthy Message." Spokesman-Review. 30 Sep. 2013: n.p. SIRS Issues Researcher. Web. 08 Mar. 2014.
A company's understanding and use of organizational behavior concepts can make or break it. Just as important, if a company ignores these same concepts, it can easily spell disaster.
The Food and Drug Administration’s (FDA) origins began in 1906 with the establishment of the Food and Drug Act. Signed into law by President Theodore Roosevelt, the Food and Drug Act (renamed in 1930 to the Food and Drug Administration) began as a law that restricted interstate commerce of food and drugs which were “adulterated” and “misbranded.” Up until that time, there were very few laws in place which regulated the sales and contents of pharmaceuticals and food products which were manufactured and produced domestically. Harvey Washington Wiley, chief chemist of the U.S. Department of Agriculture's Division of Chemistry at the time, was the powerhouse behind the creation of this law and was the driving force for the enforcement of it in