Corporate Social Responsibility: What Went Wrong at Glaxosmithkline?

Lobbyist interference from multi-million dollar pharmaceutical companies has heavily influenced Washington lawmakers’ policymaking. These pharmaceutical companies have their hand in much of the United States lawmaking practice. These powerful corporations stand to make a lot of money from the sale of drug testing supplies and services to the U.S. government. Macdonald reports:

Due to these incidents and many severe cases of drug side effects that had happened in the past including deaths, the current way drugs are developed and approved are unethical. Therefore, reform in FDA’s management as well as the guidelines is necessary to strengthen safety standards and eliminate problems regarding drug development and regulation.

Graham made a statement saying, “The people who approve the drug in the first place, within the FDA, and take pride in the fact that they’ve brought a drug to the market - that is their baby. This is their drug.” he says this because the

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.

Americans must wait up to 19 years after a discovered treatment before they can participate in benefits of a new medication (Philipson & Sun, 2008). The regulatory process drug manufacturers need to endure before releasing potentially life-saving medication is an extremely expensive, time-consuming process. The Center for Drug Evaluation and Research (CDER) is the main department of the Food and Drug Administration (FDA) responsible for the safety of drugs (both prescription and over-the-counter) sold in the United States (Food and Drug Administration, 2011). This department scrutinizes the testing of new drugs and

Point of View: In my opinion, the new law does provide a more specific regulation that will help control the manufacturing and distribution of compounded drugs. I do believe that the United States Food and Drug Administration should have more power to control and regulate the distribution of drugs, as well as have more power to inspect companies to insure product safety.

Everyone in America, is at risk for being diagnosed with a condition that they don't have, and being prescribed medications they do not need. Its, everyday advertisments on TV for clients who may have had a missed diagnosis, and experienced a side effect from a medication they where prescribed, physicians try to follow national standards of care to protect themselves from lawsuit or even losing their licenses.

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).

Romanow’s vision of a national formulary is intertwined with his larger recommendation of a national drug agency which would oversee the drug approval process, drug research and price-setting for the entire nation instead of each province and territory performing their own approvals (Romanow, 2002, p. 199). The national formulary would be based on a transparent evaluation process conducted by the agency and would erase the

The report has been divided into three parts; part-1 discusses the lawsuit in detail; part-II describes company involved in the laws suit and Part-III discusses the business impact of the lawsuit. The author has tried to cover all the aspects of the issue. Part-I discusses the actual allegations, background of the allegations, key players and the relief sought. In part-II I have described background of GlaxoSmithKline, its history, products,

Johnson and Johnson’s is a multi-billion dollar company that has been around for 129 years. The company was founded in 1886 by Robert Wood Johnson joined his brothers James Wood Johnson and Edward Mead Johnson to create a line of ready-to-use surgical dressings in 1885. The company produced its first products in 1886 and incorporated in 1887 (Johnson).Since then the company has built a reputation on its “Credo”. Simply stated, the first responsibility is to the doctors, nurses, patients, mothers and fathers who use the products then, employees, and finally shareholders. This lines up with the humanistic view of putting people over profits. As Johnson and Johnson’s grew, the company moved form a simple structure, offering just ready to use surgical dressings into a divisionalized form of many departments. With a host of products from band aids to high-margin medical devices: artificial hips and knees, heart stents, surgical tools and monitoring devices; and from still higher-margin prescription drugs targeting Crohn’s disease, cancer , schizophrenia , diabetes , psoriasis , migraines , heart disease and attention deficit disorder (Brill).This decentralized organization structure of management offered autonomy to mid and lower level manager . The issues that arose as the company grew under the structural from where Did Johnson and Johnson’s hide Risperdal study results from the Food and Drug Administration (FDA). Moreover, was there illegal marking of Risperdal?

S.959—Pharmaceutical Compounding Quality, Security and Accountability Act, was introduced into the U.S Senate May 15, 2013 by Thomas Harkin, Democratic senator of Iowa, along with the support of five cosponsors. The bill, if it’d passed would have amended the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the regulation of compounded drugs. It would have allowed the Federal Government to oversee drug compounders’ operations to ensure drug quality and safety. Most recently, the bill was referred to the Senate Health, Education, Labor, and Pensions Committee but never made it to the floor for a vote. Supporters of S.959 were both Republicans and Democrats. This bill was a bipartisan effort. There was opposition to this bill from the

The Pharmaceutical industry has been in the spotlight for decades due to the fact that they have a reputation for being unethical in its marketing strategies. In The Washington Post Shannon Brownlee (2008) states, “We try never to forget that medicine is for the people. It is not for the profits. The profits follow.” This honorable statement is completely lost in today’s world of pharmaceutical marketing tactics. These tactics are often deceptive and biased. Big Pharma consistently forgets their moral purpose and focuses primarily on the almighty dollar. Big Pharma is working on restoring their reputation by reforming their ethical code of conduct.

Over the past couple of decades, a sudden change has started to take over the way business is done. The time when no rules applied, and anyone could do what they pleased at the cost of others or the environment is rapidly ending. Instead, companies today have become aware that it is essential for them to employ ethics and morality in their actions, if not they will be heavily scrutinized and rejected by the public. This way of thinking also applies to the pharmaceutical industry, which over the past century has been rapidly expanding. Do to the fact that this industry can determine the health and lives of millions of people, it is imperative that this industry follow an ethical and moral path.