Kefauver's Wife Chapter Summaries

The 1938 Food, Drug, and Cosmetic Act mandated that manufacturers of drugs had to provide labels on their drugs. These labels provided the consumer with information about what certain drugs contained and specific directions about how to take them. This action prevented false claims about drugs and allowed consumers to know that certain drugs were safe. As a result, the scrutiny of drugs ensured the selling of safe drugs in the United States.

The Food and Drug Administration (FDA) is best known for its role on protecting the health of the public by making sure that food, medications are safe and effective. Especially when it comes to the pharmaceutical industry, its mission is to regulate pharmaceutical manufacturers, as well as the drug approval process. However, in the recent years, many arguments and controversy regarding drug development and regulation have risen. Drug advertisements make false and misleading claims, products are being put out on the market without any proof of safety, causing many unwanted incidents such as the Avandia incident and Vioxx incident, which could have been prevented in the first place.

When a pharmaceutical company creates a new drug, it has to go through the FDA and is required to submit a New Drug Application (NDA) to the FDA. The FDA reviews the application to assure that there is an objective proof that the proposed drug is safe and effective. If the

Pharmaceutical companies are provided with temporary monopoly rights on the production of new drugs which result in a higher cost on consumers. If competing companies were allowed to produce generic forms of those drugs, consumers will be able to afford those medications even in cases where those consumers have no insurance coverage. The company responsible for developing and inventing the original medication could be offered incentives to invent in the future by either obtaining tax breaks or NIH funding for future research. They could even be offered a percentage of the sales of the generic drugs. Economist Gary S. Becker advocates dropping many FDA requirements that, in his opinion, provide no additional safety measures but rather delay the development of new drugs.[12] Betamethasone, for example, has been part of the standard prenatal care in Europe since the late 1970’s while it got adopted in the U.S. after 1997. On many occasions, the FDA ignores all scientific evidence concerning certain drugs because the manufacturer did not follow their mandated bureaucratic standards.

| Created the Food and Drug Administration (FDA). It forbids the manufacture or sale of adulterated or fraudulently labeled foods and drugs.

The Prescription Drug Marketing Act of 1987 was signed into law on April 22nd 1988. The law was made to protect people from the purchasing and consuming tampered products. This includes counterfeit, adulterated, misbranded, or expired drugs. The FDA takes a special point to monitor counterfeit medication. Lately there are many serious counterfeit drugs that have been killing people. One example is that they have been finding many counterfeit drugs that contain fentanyl. Because this is such a potent pain killer people are accidentally overdosing.

A terrible incident happened in Tennessee in 1937 when a drug called Elixir Sulfanilamide was mislabeled and contained toxic quantities of antifreeze that killed over 100 people (FDA's Origin & Functions - FDA History). Before this event, Congress debated substituting the 1906 Act and this instance in Tennessee drove Congress to approve the Food, Drug and Cosmetic Act of 1938 that provided an updated set of standards. Unlike before when the government had to disprove a drug was effective, the new act stated that drugs had to be proven effective before being sold. It not only replaced the Pure Food and Durg Act, but the Sherley Amendment as well (Centennial Edition of FDA Consumer).

The final move was the 1962 Kefuaver- Harris Amendment, which tightened safety requirements and also recquired the manufacturers to provide FDA with evidence that the drug was both safe and effective for its intended clinical purpose. People of the drug industry were outraged because this would delay, often by many years, the time and cost of which a company could market a new product and begin to recoup its investment.2

At first, I didn’t know what to make of this book. I knew from the cover that the novel’s plot was centered on a murder, but I had no clue that the main character and his family was so involved. Also, when I thought of World War II, I didn’t consider the victims of the madness that occurred afterwards and the emotional damage that followed, or how the countries that were occupied by the Nazi party were decimated, pillaged, and shells of their former glory. I always thought of the 10+ million that were killed in concentration camps based on their political standings, sexual orientation, race, and religion. It opened my mind to the treachery that most likely occurred in neighborhoods where people knew each other very well but framed since they

Although all the signals from the FDA were positive, there was also the risk that the FDA, which

This story takes place at the middle of the 1800s in New York. Sloper is a very wealthy doctor and has lovely wife who enormous assets. However, he lost his first son at the age of three. After his wife gave birth to his second girl child Catherin, his wife was dead. Sloper is depressed that Catherin is not beauty and clever like her mother, and she is not a boy. Sloper lives with Catherin and Lavinia, his sister. She is a widow and loves secret and mysteries. He prefer another his sister Elizabeth who is comfortable and reasonable to Lavinia. Sloper’s family moves to Washington Square, which is a symbol of

In the United States, a drug can only be advertised legally after being approved by the Food and Drug Administration (FDA). Once attaining at least one FDA-approved use, physicians can prescribe a drug for other unapproved uses, based on their clinical judgment; this is referred to as “off-label use” (McCambridge, 2008). In general, marketing drugs for off-label uses is illegal; however, pharmaceutical companies have gone to various lengths within their legal rights to accomplish exactly that.

The story begins with a woman, Jean. She is sitting at a café when a man’s cell phone rings several times without him answering the phone. Jean got upset and asked him to turn his phone off. The man didn’t answer, but Jean got up and answered the call for him. Later on, she found out that the man Gordon has died quietly in the café. However, instead of ignores the phone call. She keeps answering phone call from Gordon’s mother, business partners and his mistress.

One factor that must be considered is that the drug had not yet been approved by the FDA, but was in phase III trials. Historical data shows that 65% of drugs in this phase eventually get approved for sale to the market. It was felt that approval of the drug would occur late in 1998.

On a cold February evening in 2009 two years ago, just outside the city of Buffalo, New York, two pilots crashed a new aircraft on final approach to land into Buffalo Niagara International Airport. In an effort to prevent an accident of a similar nature from happening, the U.S. Congress passed H.R. 5900 the ‘Airline Safety and Federal Aviation Administration Extension Act.’ This bill under Title II was aimed to enhance airline safety and in part prevent an accident of this nature from occurring again (U.S. House 2010, 3). Section 217 of bill pushes the minimum hours required to act as a pilot on a regional carrier up to 1500 total flight hours as well as requires those persons to do an extensive Air Transport Pilots examination. Although