Generic And Name Brand Drugs

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.

Woodroof shouted at the FDA during a town hall meeting “People are dying. And y’all up there are afraid that we’re gonna find an alternative without you.” This was Woodroof’s way of saying that the FDA only backs up the pharmaceutical companies because they will give the FDA incentive to put the stamp of approval on their product. “You see the pharma companies pay the FDA to push their product. They don’t want to see my research. I don’t have enough cash in my pocket to make it worth their while” he explained. This is the error the patients see in the American healthcare system, the FDA was hesitant to license new drug therapies and also didn’t want to let patient’s tryout with their own medications. AIDS patients felt like they were denied access to life-saving drugs by an insensitive federal government. Author of the book, HIV and The blood Supply, Lauren B. Leveton suggested that “The evaluation of policy decisions and actions taken over a decade ago is a problematic enterprise.” Even Woodroof’s doctor has concerns about the pharma company that makes AZT when she asks another doctor “Doesn’t it drive you a little bit crazy to see these guys talking about curing the sick while flashing their gold

The Federal Food, Drug Administration is responsible for establishing the Code of Federal Regulations which outlines the rules and regulations governing pharmaceuticals. The rules are divided into sections and include guidance based on drug categories. Due to each person having varying reactions to pharmaceutical products not all side-effects are detected during clinical testing. The Federal Food, Drug Administration is responsible for sharing the information with consumers. However, it seems a bit unethical because the large pharmaceutical companies do not have to share all of side-effect information that may assist consumers in making its choice on whether to try a product or to not try a product. Through various survey’s it was discovered that consumers are under the opinion that pharmaceutical companies need to have improved internal controls to ensure their compliance with regulations. Due to physicians and pharmaceutical companies working together and are dependent on one another there needs to be controls in place that would have an unbiased view of the regulations. The government will need to continue introducing new regulations that will aide in monitoring the relationships.

The pharmaceutical industry along with the manufacturers of healthcare products and technologies often encourage the misappropriation and distribution of marginally beneficial products and technologies in the healthcare industry. These companies often use various advertising methods to influence members of the public to request their products and services without adequate knowledge of their effectiveness and implications to their medical condition.

This is obviously a huge topic in bioethics debates, especially recently after various changes in Federal Healthcare protocols. Some people depend on pharmaceuticals as a daily part of their routine, requiring some medicine or other for a condition or health issue. A prime example of this is the recent hike in the price of epinephrine shots, commonly known as the Epipen produced by Mylan Pharmaceuticals. This medication has seen a huge increase in pricing rising from roughly $50 in 2007 to over $600 this year. This is a shot used for common allergic reactions and therefore is used or carried by millions of people every day. The concern then is that pricing will get too high and patients will have to do without some medications leaving them vulnerable or even helpless in the face of certain conditions.

H. This is not the case. In fact, a little over fifty percent of prescription generic medications are made by the same manufacturer as the brand name drug.

Another issue is too much power is given to scientists in decision-making of candidate drugs. Also there were inadequacies and lack of communication between marketing and research. Merck’s marketing and research needed to realize that the making of the drug is not only the most important part in increasing sales, but it also included a strong advertising campaign that will satisfy the needs of the customers.

Even though the pharmaceutical industry has made great improvements to human health and quality of life, like creating drugs for the treatment of AIDS, cancer, and other diseases, an increasing tension is growing between the public and the industry. These thoughts are fueled by issues such as drug pricing, affordable health care, and the battle against epidemic diseases in third world countries; social critics wonder whether this multi-billion dollar industry is giving enough back to the community and fulfilling its social responsibility.

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.

Generic prescribing is almost universally acknowledged as desirable and representing high quality prescribing in the UK. It has benefits that include reducing the risk of error as each drug has only one international chemical name rather than many brand names and, usually, reducing the cost of prescribing. There is little evidence that it detracts from patient care. European laws have meant that there has been a move from using British Approved Names (BAN) to Recommended International Non-proprietary Names (rINN), which has strengthened the safety argument and ensured that drugs of the same class have similar names which helps reduce confusion (Duerden M. and Hughes D. ,

Counterfeit medications are unsafe and a treat to people around the world. The use of the medications can cause harm to both the body and society. It is important that the consumers are educated about counterfeit mediations. Most people who purchase counterfeit medication may not understand that laws are being broken. Drugs are unlawfully and consciously being made to resemble the FDA (Food and Drug Administration) approved drug. Sellers are infringing on the companies Intellectual Property (IP), as medications are protected in law by copyright, patents, and trademarks. Copyrights are protecting the pharmaceutical copay ownership of the product, whereas the counterfeit drug suppliers are claiming the medication as the original. Fake medications are being stamped with the same logo Drug patents last 20 years and once the patent expires the owner has the authority to decide how others can use the product. The counterfeit drug supplies do not have the right to copy the makeup and design of the legitimate drug. There are many fake drugs that are slightly identical to the original. Visually the consumer may not be able to tell the difference, the drugs are the same color, shape, and include the unique logo of the pharmaceutical company. Due to the misappropriation consumers are lead to believe they are receiving the same product.

discovered and developed ibuprofen. There was a team dedicated to its development, the leaders were Stewart Adams, and his colleagues John Nicholson and Colin Burrows. They first started working on it in the 1950s, to help treat arthritis. Adams and his a associates uncovered a class of compounds, phenylalkanoic acids they acquired analgesic, antipyretic and anti-inflammatory properties. It involved ibuprofen, or isobutylphenyl propionic acid. Ibuprofen was first tested on cats and rats. The tests showed that ibuprofen had no impact not the cardiovascular system, nor did it have an unfavorable impact in the respiratory system. After that ibuprofen experienced substantial clinical tests. Trials were done on people that have arthritis, hyperpyrexia, and lumbago. It showed that most of them that received a daily dose of 800 milligrams- 1200 milligrams had remarkable improvement. They had a reduction of pains in their joints, stiffness, joint swelling, and symptoms of carditis. Ibuprofen was patented in the earlier part of 1961, but it was not sold until 1969. Ibuprofen was approved by the FDA, Food and Drug Administration, in 1974 and sold int the USA that year. Ibuprofen is a widely know over the counter drug, but man other drugs are the same except they

Pharmaceutical companies should attempt to be as transparent as possible when marketing prescription drugs to the public. Their marketing efforts should not only convey the benefits of the prescription drug, but also easily convey the possible risks associated with the prescription drugs. Many patients may tend to think the benefits outweigh the potential risks of prescription drugs and may pressure their physician to prescribe it. Due to the way the prescription drug is marketed, the consumer may believe the

When they first appeared, generics were seen as threats to brand products, particularly for products for which lower price might be a primary criterion for purchase. Although generics enjoyed growth during the recession of the early 1980s, with increase in American incomes, they have now dropped back to their selling level at introduction. In their growth stage, however, the threat they posed to brands stimulated major manufacturers to bring out lower-cost brands that were more competitive with the generics. It is interesting in studying the no-name generic phenomenon to compare these products with a product like Coke, which, because of years of advertising, has such a strong personality.

There were two important developments in the 1970s which further shaped the industry in the form that we see today. Firstly, the Thalidomide tragedy (where an antiemetic given for morning sickness caused birth defects) led to much tighter regulatory controls on clinical trials, greatly increasing development costs. Secondly, enactment of legislation to set a fixed period on patent protection (typically 20 years from initial filing as a research discovery) led to the appearance of “generic” medicines. Generics medicines are those that have exactly the same active ingredients as the original brand, and compete on price.