1. Food Regulation Q: Are they guilty? A: Yes, Gel Spice is guilty, because they are selling clearly adulterated food. According to the textbook, “The FDCA prohibits the shipment, distribution, or sale of adulterated food. Food is deemed adulterated if it consists in whole or in part of any ‘filthy, putrid, or decomposed substance’ or if it is otherwise ‘unfit for food’,” (p.200). Food containing rodent droppings, urine or live rodents is clearly unfit for food, and Gel spice is guilty of selling adulterated food according to the criteria given by the FDCA in the textbook. 2. Regulation of Drugs Q: Who wins? A: Dey Laboratories wins because the FDA is not given express permission to seize merchandise. It’s functions and abilities include “the authority to regulate testing, manufacture, distribution, and the sale of drugs,” as well as require “all users of prescription and non-prescription drugs to receive proper directions for use…and adequate warnings about any related side effects,” (p. 201). However, they do not include the ability to seize merchandise. In conclusion, based on the duties allowed the FDA noted within the textbook, Dey Laboratories wins because the FDA is not given express right and permission to confiscate merchandise. 3. …show more content…
Cosmetics Regulation Q: Who wins? A: FBNH wins the challenge of the government’s right to seize the tablets, because the FDA does not have express right to do so. However, the FDA does have over the “manufacture, distribution, or sale of adulterated or misbranded cosmetics,” (p. 201-202). Effectually, the FDA cannot seize the tablets but they can control the distribution and sale of them. Conclusively, FBNH wins the challenge of the government’s right to seize the tablets, but the government does retain the right to stop distribution and sales of the tablets. 4. Drug
“Do you want a man who can bake you a gourmet cake in the dream kitchen that he built for you with his own hands? Of course you do.” Old Spice man asks his audience this question among a series of other rhetorical questions as he transitions, to continuously fit the image of the perfect man. The commercial begins with an attractive, charismatic Old Spice man standing in a towel bare-chested, on the beach holding a bottle of Old Spice. He associates being an attractive model man, with using Old Spice body wash. He then transitions into an adventurous man wearing khaki shorts, walking on a log, and then walking on water. After he carries said gourmet cake into the dream kitchen, he swan dives off a waterfall, into a hot tub. The commercial ends with the man sitting on a motorcycle holding a bottle of Old Spice body wash; modeling being both an Old Spice man and the ideal man, with the slogan SMELL LIKE A MAN, MAN. Old Spice, in the background. Humor is achieved by the tone that is set. The ad campaign is funny to a point that the commercial is pretty much making fun of itself. The sex appeal is apparent as the bare-chested man sells the product of a man, man. The product name and logo are repeated and shown throughout the entire ad, making repetition a strong selling point. This advertisement is effective because it appeals to a wide audience using humor, sex appeal, and repetition to sell the product.
In 1975, Acme Markets, Inc., a large national food chain and its CEO, John R. Park, were convicted of keeping food sold in interstate commerce in a rodent-infested company’s warehouse, in violation of federal regulations . According to the responsible corporate officer doctrine, the court found Park severely liable for the unsanitary circumstances of this corporation, as this offense involves protecting the public health and welfare of patent dangers. Park was charged guilty of violating 301(k) of the Food, Drugs and Cosmetics Act (FDCA), which protect consumers against adulterated and misbranded foods and drugs.
Economic responsibility requires a company to remain profitable in order to appease stakeholders and risk management and sound business practices play a large role in acceptable economic responsibility. Johnson and Johnson may have tried too hard to increase its profits, which resulted in mediocre production rather than timely inspection to ensure the products are safe for distribution. A halt in production may decrease profits temporarily, but in the long run, products distributed will be safer and revenue would resume to a normal amount. Instead, trying to be profitable and avoid loss in the short run made Johnson and Johnson less profitable in the long run. Failure in legal responsibility may have caused Johnson and Johnson to fail. The Food and Drug Administration (FDA) regulates drug distribution and has several criteria to pass in order to allow Johnson and Johnson to administer its premier medicines such as Tylenol. Not adhering to those laws allowed the distribution of unsafe medicines, subsequently leading to recalls and damaging the company financially. Johnson and Johnson tried covering up prior recalls of Motrin by hiring contractors to buy every packet (Kimes). Ethical responsibility requires companies do not perform questionable practices such as that described. The secret recall bought attention to Johnson and Johnson that it makes shoddy products out of the public’s view, which is wrong on many ethical bases. In the recent occurrence with Tylenol, Johnson and Johnson slacked on its labeling and tarnished the company’s
The appropriate court for this lawsuit depends upon several factors. Three important considerations include personal jurisdiction, subject matter jurisdiction and minimum contacts. Personal jurisdiction is the power the courts have over parties involved. Minimum contact is the contact required between a party and a state in order for the courts of that state to constitutionally assert power of that party within specific boundary (Kubasek, p. 42). Because Funny Face promoted their product over the internet and sold to customers worldwide this would apply to them. The reason of the lawsuit stems from the aftershave lotion that caused the side effect of a permanent blue face for a Donald Margolin. The cause of the discoloring was due to the replacement of a key ingredient to PYR (a chemical emulsifier) which is not FDA approved. The contract between Funny Face and Novelty Now notes that all disputes must be heard in the state of Florida. Subject matter jurisdiction refers to the nature of the claim or controversy. Subject matter jurisdiction is the power of a
and yet simple of the act, which severely impacts pharmacy and is forbidden by the PDMA, is the act of knowingly trading, purchasing, or knowingly selling a prescription drug sample. This offense is punishable for a fine of up to two hundred and fifty- thousand dollars, and up to ten years of imprisonment. Many pharmacists do not realize is that there is a fee of up to one hundred and twenty five thousand dollars for the individuals who provide information leading to the conviction of a violator of the PDMA. Another important portion of this vast law is that it prohibits pharmacists to resale of any prescription drug that was previously purchased by hospitals or any other health care facility. The provision was intended to eliminate a major source of drugs in the diversion market such as; drugs that were originally purchased by hospitals or health care facilities at substantially discounted prices, as allowed by the Nonprofit Institutions Act of 1938, and then resold to the retail class of trade. Congress believed that the resale of such drugs created an unfair for of competition. Re...
The FDA says that they test there medicines on healthy patients but hundreds of people die from simple mistakes like not watching each person side effect and report the correct information in clinical reports. NO criminal charges were faced to Johnson and Johnson and I think some criminal charges or a settlement for patients who experienced the side effects that the drug Risperdal caused. Each year the FDA take 100,000 people lives from taking medicines that are being approved by the FDA. Who is the FDA truly protecting and what responsibilities does the FDA accept due to the fact that more deaths are led by drugs that are approved by the FDA. The FDA say there for the people but are they really thinking about the lives there taking or the money that their gaining from the drugs they approve each year. The FDA is responsible for protecting the public health by ensuring that human and veterinary drug, and vaccines and other biological products and medical devices intended for human use are safe and effective. The FDA should no longer approve medicines that may cause severe side effects or in some cases death; drugs who manufacture these medications should face criminal
The FDA is a necessary agency because they regulate what is put into our cosmetics and
Government factors into the equation of the argument. Critics of the drug industry say that there is not enough regulation, while supporters of the pharmaceutical companies argue that there is too much regulation and that that is one...
“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.
dangerous drugs to other states. This article proves how important and how advanced FDA regulation
both the benefit and risk of all medication before approval.. In addition, FDA makes the labeling
The following paper discusses the Federal False Claims Act, 31 U.S.C. §§ 3729-33 in more detail. While such violations may involve various types of health care providers, focus is placed on the applicability of the law within the pharmaceutical sector of health care. The roles and responsibilities of a health care administrator within the pharmaceutical sector are also discussed considering the impact this entity may play in preventing such violations (e.g., knowledge of law, how it impacts daily operations, consulting with legal entities, regulatory compliance, etc.).
It would have eliminated all the troubles and saved the company’s reputation if this was in place. Though when the intention of the drug was to help epileptic seizures, you fail to look at the other uses this product could have. In regards to the handling of the issue, Lundbeck should have taken a more aggressive stance against the prison’s usage of the drug. Writing letters will only take you so far and Lundbeck did not give them any ultimatum if they did not comply. Lundbeck was too passive in the handling of the situation. They should have reached out to more than just the prisons and state governments. This case I do believe is a federal matter as it effects more than one state so it should have been taken to the federal court to be hammered out. Even then Lundbeck’s response time to the issue was pretty slow and it might have taken the case longer to resolve. Lundbeck could have also maintained better contact with human rights organizations and NGOs Reprieve and Amnesty International so that a plan of action could have been sought out earlier knowing that the prisons and the government were not going to do anything about
The enactment of the Food, Drug and Cosmetic Act of 1938 tightened drug and food controls, included new consumer protections against cosmetics and illegal medical devices, and improved the government's ability to enforce the law. Although the FDA's origins date back to the appointment of the chemist Lewis Caleb Beck to the Division of Agriculture at the Patent Office in 1848, its origin as a federal consumer protection agency began with the approval of the Pure Food and Drugs Act of 1906. This law was the culmination of approximately 100 bills for twenty-five years that proposed to stop the serious and prolonged abuses in the market of products for the
Other companies cannot replicate the drug and therefore they are forced to either wait until the patent expires or they must find an alternative drug that carries out the same purpose.... ... middle of paper ... ... It is clear to see that there are many pros and cons to patents in the pharmaceutical industry.