Healthcare Regulation Of The Pharmaceutical Industry

Do you think government regulation of the drug industry is important? Why or why not?

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

Specify the types of country risks that pharmaceutical firms face in international business. How do the political and legal systems of countries affect the global pharmaceutical industry?

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 current system is inefficient, inequitable and unsustainable in the long run because: (1) it is unable to accommodate for the entire Canadian population; (2) it requires Canadians to pay a disproportionate amount of their income to access medications; and (3) governments are unable to contain the drug cost increases (5). Therefore two recommended reforms are described in order to achieve the goal of accessibility and equity.

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

One of the greatest problems we face in America today is the use and abuse of drugs in our country. It is important to find a solution that works within our country to combat the growing populations of our nation’s prisons, keep the supply of drugs under control, and have adequate prevention programs in place to help people who need treatment. Throughout reading the material for this course and the research conducted on the topics described in this paper, it is clear that the methods used in earlier years were not able to achieve the results we would like to see. Advocating for reform and the support of the American people can help with the desperate need for change.

In the video Escape Fire, I was so flabbergasted by the numbers and health outcomes we as a society have let our nation become. One of the most heart-wrenching evidence is, even though our health care industry is so expensive our health outcomes are the worse. 75% of disabilities and dead’s are preventable, according to the film.

R/s Kim is sending Kadyn to school with medication and it is against school policy. R/s last school year Kim was advised not to send medication with the child. R/s last week Kim sent the EpiPen and this week she sent Benadryl with Kadyn. R/s she called Kim on yesterday regarding the medication policy and Kim response was “okay.” R/s Kim gave permission for the school to change Kadyn’s clothes at school. R/s the school has clothes for Kadyn due to the strong odor. R/s Kadyn’s bookbag has to sit outside of the classroom because of the urine smell. R/s last year, they had the same issue with Rodney.

The FDA requires pharmaceutical companies to conduct years of research on their drugs before they begin the actual process approval. Drug companies submit test results to the FDA to be reviewed by their scientists; the FDA actually does no preliminary research on the drugs. In order to be approved, the companies must prove to the FDA that each drug is safe and effective and that the benefits of the drug must outweigh its side effects. The FDA has 800 to 900 employees involved in reviewing drugs before they get to the market. After a drug is approved, the FDA researches by collecting and analyzing thousands of reports each

On september 2nd 2011, a Twenty-four year old man from cincinnati named Kyle Willis´ fell victim to the corruption of the pharmaceutical industry(Gann, Carrie). Willis had a severe toothache on his wisdom tooth that resulted in its extraction. After the surgery, Willis´s face started to swell and was sent to the emergency room. He was prescribed antibiotic medications and also painkillers in order to follow standard recovery procedure. Kyle Willis’ could not afford both drugs so he just purchased the pain killers because of the swellings unbearable pain. The infection continued to spread into his brain which lead to severe brain swelling and eventually Kyle Willis’ death. Kyle Willis’ died because he could not afford the medication that would have saved his life. There are many other people that can 't afford the drugs they need, which results them losing their lives. According to harvard studies, over 45,000 people annually die due to lack of health care coverage(Harvard Gazette). According to their studies, those who are privately insured have 40% chance less of dying than those who have insufficient funds(Harvard Gazette). The monopoly and corruption of the pharmaceutical industry is un-american and inhumane because it causes the middle class to not receive the help they need to recover.

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

There are many direct to consumer advertising for prescription drugs. On television, magazines, radio etc, you see the most recent advertisements for prescription drugs. After some people see the advertisements they soon rush over to their doctor and their illness and life would be perfectly pain and stress free. Making the public conscious of options for treatment is not a bad thing. But these false advertisements are misleading consumers onto unnecessary treatment.

Yes, there is an impact on the pharmaceutical company, like those in the US as a result of differential prices between that country and other nations.