Abstract In this article, the writer looks at the history, aims and actions of the Food and DrugAdministration (FDA). The writer notes that during its evolution, the Food and DrugAdministration has encountered numerous important problems which have created the necessity to enact and implement many laws and legislation. The writer discusses that the FDA petitioned for changes in laws concerning, among other issues, the quality of foods and the therapeutic claims of drugs. In conclusion, the writer maintains that the Food and DrugAdministration is a professional and ever-evolving agency which has acted not only as a pioneer but has also maintained itself as a world leader in its field. Of course, leadership is a lonely road and despite recent criticism and media backlash, the writer feels that the agency has done an excellent job protecting the American people and has upheld its mission statement to the best of its ability.
From the Paper "Generally speaking, drugs were considered adulterated when their standards of strength, quality, or purity differed or fell below that of the United States Pharmacopoeia or National Formulary. Misbranding occurred when drugs were imitated, offered for sale under the name of another product, and/or the contents of the package having been wholly or partly removed with other contents put in its place. Misbranding also took place when the package failed to state the presence of alcohol, morphine, opium, cocaine, heroine, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate or acetanilide on its labeling. Confectionaries were considered adulterated when they contained alcohol, any narcotic drug, terra alba, barites, talc, chrome yellow, other mineral substances, poisonous colors or ingredients detrimental to one's health."
Abstract The U.S. Food and DrugAdministration regulates many of the products you use in every day life. Yet, there are many drugs on the market that have not been approved by the FDA. This paper examines the legal and ethical issues that surround these lawful, yet unapproved by the FDA, drugs that are on the market.
Abstract In the United States, the government and its agencies do not maintain the same regulation of herbal remedies in the same way that they ensure the safety of other foods and medicines. Furthermore, while these products were once the mainstay of only such minute groups as vegetarians and other counterculture types, they have now become widely popular among the general public as the widespread assumptions about their safety and naturalness has permeated contemporary society. The paper argues that, on the other hand, many professionals within the medical community conversely claim that the dietary supplement industry is selling modern day snake oil that has no proven safety or efficiency. In the end, both factions are correct, and in spite of the natural base of herbs and dietary supplements that can make these products appealing even when traditional medicines are not appropriate, these items are also powerful medicinal agents. The paper shows, therefore, that due to the public's lack of ability to make informed decisions surrounding these products, the Food and DrugAdministration must be granted the same sovereignty over herbal remedies and vitamins that it maintains over other foods and medicines.
From the Paper "Still, one reason that some people believe that it is not necessary for the government to become involved in this industry is indeed largely because of the mistaken belief that these agents are safe merely because they are natural. In fact, according to one 1997 poll, more than half of consumers who use natural remedies are convinced that they are equally as safe and effective as traditional treatments like aspirin ( Greenberger 1077). However, since 1994 there have been reports of at least 34 deaths and nearly 900 adverse reactions--including heart-rhythm disturbances, heart attacks and strokes associated with supplements that contain one herbal stimulant that is often taken to boost energy and to lose weight (Josefson 1440)."
Abstract In this paper, FDA leveraging and the impact special interest groups could have on protection of human research subjects is discussed. Initially, an overview is provided of FDA leveraging, including a definition of leveraging and a discussion of relevant background information, basic principles, and types of partnerships involved in the process. Subsequently, the oversight of FDA leveraging is described. This is followed by a discussion of the legal and ethical issues associated with the process. Conflicts of interests (COI) as well as potential conflicts of interest are identified. After this, information is provided as to strategies to avoid the emergence of COIs. Finally, a summary of the information provided within the paper is provided.
From the Paper "Leveraging, as implemented and utilized by the US Food and Drug Administration (FDA), has been defined as the development of relationships and/or formal agreements with others outside the FDA, designed and intended to enhance FDA's capacity to meet its public health mission. As such, leveraging within FDA represents a continuum for gaining advantage and support in fulfilling its public health goals and undertaking."
Abstract This paper examines the debate between the East and West on the issue of safety on genetically modified food. The author looks at the argument concerning the food's safety, and possible effects on the human body, labeling of such products, and how the U.S. Food and DrugAdministration use modified foods.
From the Paper "The world as we know it is divided into two parts---the secular West and the cultural East. Both have different manners of living and while the West blooms in progress the East is more restricted as it looks for the morality and values behind the progress being made. In such a division controversies like genetically-engineered food bring home the difference as both the divides through the globe argue the safety of the food-albeit on different grounds. At the heart of the debate lies the argument that as yet, the effects of genetically modified crops and products on the human body are not known. However, there is no conclusive evidence of whether or not they can be harmful.."
Tags: east, west, FDA, poison, biotechnology, risk, label, population, health
Abstract This paper looks at how the consumption of alcohol, tobacco, and legal or illegal drugs by the mother during pregnancy can cause serious defects in the future physical, emotional, and intellectual development of her child. The paper also examines how the medical theories on Fetal Alcohol Syndrome have changed over the last decades.
From the Paper "For the record, those who work closely with FASD children point out that they may have certain positive characteristics in common that other children their age may be less prone towards, such as being tactile, loving, cuddly, clingy, with a lot of determination and persistence and compassion. They tend to be friendly and trusting (if to a fault) and have lots of spontaneous energy. Of course, many of these positive traits are brought out not so much by the syndrome itself as by the way the caretakers respond to the syndrome. Without proper parental (whether biological or adoptive) care, many FASD children become even worse off than they were destined to be by their early developmental setbacks. In fact, it has been theorized that some of the worst problems with many substance-abuse babies comes in equal amounts from the actual substance in their own bloodstream and from the way their parent's substance abuse will affect their future life."
Abstract The paper relates that the FDA has been accused of being too slow as well as lacking oversight and in need of even more periodic reviews of previous approvals. The paper discusses the pressure from patient groups as well as doctors and pharmaceutical companies to expand the FDA approval and testing process to include experimental drugs. The paper devotes time to the politicization of the FDA and the accusations of bias towards the pharmaceutical companies. The paper also reveals that many American pharmaceutical companies are now outsourcing their clinical trials, which might make it more difficult for the FDA to follow every step of the trial method and results.
From the Paper "Just what does the FDA do? Government documents state that the FDA seeks to protect the public health by ensuring the purity and security of foods; the safety and effectiveness of drugs, medical devices, biological products, and radiation-emitting products; and the safety of cosmetics. The FDA oversees the review and approval of new medicines and medical devices. It also monitors the safety of dietary supplements, though it does not review and approve the supplements before they are sold.
"The FDA helps to ensure that people receive accurate information about the foods and drugs that they use. The agency calls for the truthful description of product benefits and risks and for safety and honesty in packaging. In fact, the information about contents and dosage found on food packages was developed by the FDA."
Abstract In this article, the writer notes that the research and development on a new drug is expensive and time-consuming, followed by a lengthy trial and a lengthy approval process by the Food and DrugAdministration (FDA). The writer points out that Zometa was approved for the treatment of hypecalcemia, a common metabolic complication associated with cancer. The writer discusses that research into the action of the bisphosphonate zoledronic acid (marketed as Zometa) was undertaken to gain FDA approval for use of the drug for the treatment of osteolytic bone metastases, and research is also under way for use of the drug for other purposes as well. The writer concludes that so far, approval has only been given for its use in treating cancer patients with bone metastases, though there are indications that it will be valuable for breast cancer patients facing other difficulties.
Outline:
Introduction
Medical Problems to be Addressed
Drug Action
Approval of the Drug Conclusion
From the Paper "Hypercalcimia of malignancy is considered the most common life-threatening metabolic complicastin of malignancy. It affects some 10 to 20 percent of patients with advanced cancer, varying widely with the type of cancer involved. It occurs most often in patients with multiple myeloma and carcinomas of the lung, breast, kidney, and the head and neck. Antihypercalcemic therapy is used, but median survival under these conditions has been found to be 30 days. Certain symptoms diminish the quality of life for these patients, such as nausea, vomiting, and altered mental states. HCM can also produce renal failure. Patients with bone metastases can also develop HCM. Factors that mediate hypercalcemia stimulate excess bone resorption and the release of calcium from the bone matrix, meaning that patients experience bone loss, a weakened bone structure, and higher circulating calcium levels. Bisphosphonates inhibit bone resorption and are the most effective therapy for HCM. Pamidronate has been one of the most commonly used treatments for HCM."
Abstract Discusses the historical origins of the agency's legislative powers and duets, its operations and impact, the FDA's power over the approval or rejection of a new drug or device, and the life or death consequences if approval is delayed.
From the Paper "This research paper summarizes and discusses the role of the United States Food and Drug Administration (FDA) in the regulation of health, the historical origins of its legislative powers and duties, its operations and their ..."
Abstract The paper analyzes the mechanisms by which National Drug Regulatory Authorities in "Developing" Nations and "Developed" Nations address counterfeit pharmaceutical issues with an emphasis on regulatory authorities in Nigeria and the United States. The research indicates that the Food and DrugAdministration (FDA) is working to guarantee that consumers are protected from counterfeit drugs and the adverse effects that they produce. The research also reveals that some of the strategies taken are successful but much more must be done to control the influx of counterfeit drugs coming into the country through the Internet and shipments. In Nigeria counterfeit drugs are a serious and widespread problem. Though the government has made a concerted effort to combat counterfeit pharmaceuticals and has been successful in some respects, the problem is so widespread and has existed for so long that it is difficult to remedy.
Contents:
Introduction
Definition of Counterfeit Pharmaceuticals and the Problems they cause in the United States and Nigeria
Counterfeiting in the United States and other Developed Nations
Counterfeit Drugs in Nigeria
Regulatory Authorities in the United States and how they Plan to Combat the Distribution of Counterfeit Pharmaceuticals
Regulatory Authorities in Nigeria and how they Combat the Distribution of Counterfeit Pharmaceuticals
Discussion and Conclusions
From the Paper "According to the American Food and Drug administration (FDA) counterfeit drugs are defined as fake medicine that may be contaminated or contain the incorrect or no active ingredients (Consumer Education: Counterfeit Medicine). According to the World Health organization researchers have found an abundance of counterfeit drugs throughout the globe. The most common counterfeit drugs were homemade counterfeits, mislabeled measurements and insufficient active ingredients. The World Health Organization reports that
"Counterfeit medicines are deliberately and fraudulently mislabeled medicines with respect to identity and/or source...Counterfeiting applies to both branded and generic products, and ranges from the illegal use of copyrighted commercial brands to manufacturing fake medicines. Counterfeiting is a far more pronounced problem in developing countries. National measures alone have not been proven adequate to combat this activity (Counterfeit Medicines)." "
Abstract This paper is an argumentative essay that maintains the Food and DrugAdministration must step up to its duty to protect the public health by more closing monitoring and by increasing sanctions against pharmaceutical manufacturers who engage in misleading or false direct-to-consumer pharmaceutical promotions.
From the Paper "Pharmaceuticals that improve the health of individuals and improve quality of life are good for society. Regulation of those pharmaceuticals by government regulatory agencies like the Food and Drug Administration ..."
Analyzes bureaucratic problems, focusing on approval of new drugs. Organization, powers, consumer safety, deregulation, examples, impact of drug companies, reform.
3,600 words (approx. 14.4 pages), 17 sources, 1996, $ 127.95
From the Paper "Twenty-five percent of the American consumer dollar is spent on products regulated by the Food and Drug Administration (FDA). Each day in America there can hardly be an individual or, for that matter, a pet or stock animal that does not eat foods, take drugs or use devices that have been, at some stage, regulated by the FDA. The control of such a vast array of products has generated a large bureaucracy that has been under intensifying siege for the last fifteen years. The terms of the siege vary considerably. The deregulating impulses motivating the Reagan-Bush administrations produced as much criticism of the FDA as have the pro-regulation feelings of consumer advocacy groups. The agency has been criticized for its excessive indulgence of the industries it regulates and it has been accused by these same industries of producing pointless barriers to economic and..."
Abstract This paper examines the FDA, an agency that is a regulatory and public health agency that oversees most food products (other than meat and poultry), human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products used by doctors and the consumer, cosmetics and animal feed. Its role in the Vioxx problem is discussed, along with possible solutions.
From the Paper "Drugs are introduced to the marketplace after what may have been years of development, a long series of trials and the presentation of test results to the Food and Drug Administration (FDA) for approval. The agency is a regulatory and public health agency that oversees most food products (other than meat and poultry), human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products used by doctors and the consumer, cosmetics and animal feed. The agency began with a single chemist in the U.S. Department of Agriculture in 1862 and now has a staff of approximately 9,100 employees and a budget of $1.294 billion, including chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, lawyers and so on."
Abstract This paper discusses the strategies that should be taken by a frozen food manufacturer to prevent the passing of an FDA ruling regarding labeling of pre-cooked frozen food products. The writer suggests that in the event of failing to achieve the primary objective, steps should be taken to lobby Congress to amend the regulations. He then goes on to present a detailed plan of action that would, in his opinion, facilitate the attainment of the company's objectives.
From the Paper "National Pizza should then embark on an advertising campaign that promotes their products as part of a health diet that includes all foods in moderation. This will help people that are on the fence about buying the product after labeling, should this happen, make the decision to buy the products offered by national pizza anyway. There are many high fat products that are not labeled, but incorporated into healthy diets. Examples of these include avocados, nuts and nut butters. The key to National Pizza's success will be our ability to convince consumers and the government that labeling of products with high fat is no more effective for helping people control their weight and eating habits than is labeling fruits and vegetables. People are just as likely to become overweight by eating foods that are labeled "low fat" or "sugar free". In fact, many people recognize their own tendency to eat more if a fob is labeled low fat. Rather than have people eat too little because a food may be labeled "high fat" despite any health benefits it may have, the FDA should spend its time educating consumers. Congress should promote bills that will encourage customers to become better educated about the foods they eat. They will make more money convincing people to buy organic products and fast food in moderation than they will simply labeling foods "high-fat" because such labels are not a true deterrent. People will always buy what is convenient for them."
Tags:FDA congress legislation lobbying, public health, health and safety, sales
Abstract The paper states that the majority of legislators have declared themselves proponents of the war on drugs. The paper explains that the most practical political solution to reduce drug addiction is the Pure Food and Drug Act, which was legislated in 1906. The writer explains the three main sections of the act as follows: it was responsible for the introduction of the Food and DrugAdministration in Washington - an organization that must approve all foods and drugs meant for human consumption, it stipulated that certain drugs could only be sold on prescription and it required warning labels on products that can be potentially habit-forming. The paper discusses the punishments for drug possession and how it has changed and become more severe over time. The writer explains that instead of substance abuse being treated as a public health crisis, it has been framed as a crime epidemic. In conclusion, the writer lists a number of influential Americans who support decriminalization of drugs in America.
From the Paper "Talk about practical politics! After 1916, if somebody was found in possession of an ounce of cocaine, they would have committed a criminal crime - but not possession of a controlled substance. They were tax evaders!
"Meanwhile the states were struggling with their own local substance abuse problems. Evidence of prejudice that motivated the marijuana laws in the Rocky mountain and southern western states can still be found in legislative records.
"For example, in Utah, Mormons who had always been opposed to intoxicants of any kind, enacted religious prohibition as a criminal law after witnessing Indians using marijuana. It was the first criminal law in this country's history against hemp.
"In 1936, President Franklin Roosevelt was reelected in the largest landslide election in this country's history till then. He brought with him two Democrats for every Republican, all, or almost all of them pledged to the economic and social reform packages we today call the New Deal. Meanwhile the American Medical Association, from 1932 to1937, consistently opposed every piece of New Deal legislation. The Republicans who discovered that AMA members were proponents of this proposed prohibition, sided with the medical professionals."
