The Drug Approval Process Essay

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

In our experience with Pharmasim we learned that Marketing decision making must be very sensitive and responsive to everything going on in the industry which is very complex. Consumer responses to marketing tactics can be volatile and unpredictable and no idea is guaranteed to work well. Marketing is a matter of meticulous research, assumptions, planning, and volatility at times. Overall we took away two major points: 1) that it is important to consider the product lifecycle in evaluating how to promote businesses and, 2) that the “Sweet Spot” as a competitive advantage should be the greatest point of consideration when evaluating how to best gain leverage to beat the competition in the minds of

The intended use of medications is meant to improve a person’ health, it is very important the individual administering medication or self-medicating use the drugs correctly, by following the doctors’ instruction for the medication prescribed. Medication is given to diagnose, treat, and prevent illness. Medication can be very dangerous, which can potentially cause harm or even deaf if it’s not used properly.

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.

U.S. based companies hold rights to most of the world’s rights on new medicines and holds thousands of new products currently being developed. As of 2012, the industry helps support almost 3.4 million jobs in the U.S. economy. It is also one of the most heavily R&D based industries in the world. In the United States, the environment for pharmaceuticals is much friendlier than other countries around the world in terms of pricing ability and regulations. Both the Pharmaceutical and Biotechnology industries have experienced significant growth in the past year with year-over-year increases of 13.02% and 34.69% respectively. It is an even more striking when looking at the past five years considering both have beat out the S&P 500 with pharmaceuticals increasing an additional 31.44% and the biotechnology sector besting an astonishing 269.3% more return than the

Even though the pharmaceutical industry had been highly profitable and contributed about 40% OF Ciba-Geigy’s revenues in profit, there were some trends, which were worrying. The government had attempted to reduce a cost of healthcare thus; pressure to lower costs was mounting on industrialized countries. There were restrictions to introduce new products, and price control became stricter while limiting the freedom of doctors to prescribe medications. Patent controls were becoming reduced, and the pharmaceutical industry was becoming increasingly criticized. These trends later made the industry to

This formed trade-off leads the FDA to unpleasant consequences which is why it’s important for them to collect information, about the drug and the political parties involved, that can help determine when to reject or accept a reviewed drug. In addition to that, delaying an approval can cause issues with the political parties involved in the drug or the specific disease. With new drug application (NDA), it gets a bit tricky. First, if an NDA for a disease with very few to no recent drugs being developed was reviewed, it would be hard to refuse it due to possible political consequences. Second, the FDA puts its reputation at risk everytime an NDA is being reviewed and possibly approved. Furthermore, the decision for a drug is based on three important characteristics: inherent uncertainty, asymmetric observability of error, and low reputational

The U.S. Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services that is responsible for assuring the safety, efficiency, and quality of drugs and vaccines. In America a drug must first be evaluated by the Center for Drug Evaluation and Research (CDER), which is a division of the FDA, before it gets approved for sale. This means that the department must make sure that the medicine been evaluated works properly and that its health benefits are greater than its identified risks. A company or a sponsor that is introducing the new drug initially performs a laboratory and animal tests to determine the safety and the effectiveness of the drug in humans. Once this step is successfully completed, several tests are implemented in people to confirm that the drug is safe when used to treat a disease and whether it provides a real health benefit. Finally, results of the tests that prove the safety and the effectiveness of the treatment are sent to the CDER. After a group of experts at CDER reviews the submitted evidence and ensures that the medicine's health benefits surpass its known risks, the drug can then be sold around the US (Development & Approval Process (Drugs), 2014).

When I was a kid, I always wondered why it took so long for an ill person to become well again. I always thought that if the ill person went to the doctor they would be back to normal the next day, but that’s not the case. For some people it took several days, weeks, months, and even years to conquer an illness but as a child I never could understand that. I don’t know how many times I’ve asked my mom or dad how come the doctors don’t get together and make a “miracle” drug that could heal anything and everything. It wasn’t until the age of 15 when my grandmother was diagnosed with breast cancer that I understood why it took so long for others to heal and the process that they had to endure in order to be healthy again. Shortly after my grandmother’s diagnosis, I started looking into what it would take to get a drug that would cure cancer through the approval process on the shelf to save some many others just like my grandmother. But I kept running into a dead end. Everything seemed to keep pointing towards chemotherapy and radiation. Although I wanted something to heal my grandmother fast, chemotherapy and radiation was the only solution if I had wish to see her watch me graduate high school. I went to almost every appointment with her to watch how it helped strengthen but also watch as it drained her energy. A month of chemotherapy and a few weeks of radiation and my

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.

The importance of this report, Secrets of the drug trials, is that we understand the conflict between the financial gain of the pharmaceutical industry in comparison to the actual health benefits that the drugs provide. The demand for bigger, better drugs has grown exponentially due to stigma connected with mental illness. In Secrets of the drug trials it became evident that the recovery of the patients was secondary to the public opinion of the drug. This is a common occurrence when the drug analysts are also benefiting when the drug passes its review. Although there are many objective companies and review boards that go through their data,they can only review the data that is made available to them. Findings that are not beneficial to the company can be hidden and in turn not discovered until it has deadly repercussions.

After all research has been conducted including the testing of all animal and human studies associated, the New Drug application is completed by the drug developer. The results provided are used by the FDA to determine whether the drug is approved or the recommendation of further testing. Finally phase four is based on the monitoring of the drug’s risks and benefits monitored by various sponsors hired by the FDA.

Large pharmaceutical companies spend millions of dollars and many years developing new and innovative medications. To protect their investment of time and money, they apply and are granted patents from the government, which gives the scientist and pharmaceutical companies a protected period of time that they can be assured that others will be prevented from selling their invention (Williams & Torrens, 2008). This protected period of time gives these companies a period of time that they can sell their new product at

There are over 7,000 rare diseases affecting between 25 and 30 million Americans (Global Genes 2016). A disease or disorder is defined as rare in the U.S when it affects fewer than 200,000 Americans at any given time (Eurordis 2016). Some of these rare diseases come with even more rare and controversial decisions. “The FDA just made its most controversial drug approval of the year” (Fortune 2016). This injectable drug is called eteplirsen by Sarepta Therapeutics and it is an exon-skipping drug targeting a section of genetic code called “exon 51” in the dystrophin gene. Exon skipping is a type of strategy that is being developed for the rare disease DMD (Duchenne Muscular Dystrophy). The exon-skipping process skips sections of genetic codes during protein manufacturing, allowing cells to create shortened but partially functional dystrophin protein which is the muscle protein that is missing in DMD. This rare X-linked disease was first described in the 1850’s by French neurologists Guillaume Duchenne but was not known to inhibit the production of protein dystrophin and result in the loss of motor functions and muscular degeneration until the 1980’s (MDA 2016). 1 in 3600-6000 live male births has resulted in DMD (Bushby 2010). Most patients are diagnosed around 5 years of age when their physical abilities are no longer similar to their peers (Bushby 2010). If left untreated, signs of deterioration in muscle strength increase, the chance of using a wheelchair before their teens

Phase III is the first large-scale trial of human testing. This phase can only begin if the new drug shows to be effective in the phase II. Phase III seeks to further determine the effectiveness of the drug. This is done by testing the drug on different populations, meaning that testing will be done on more people, testing will be done on different drug doses, and the drug will be tested on patients who are also taking other drugs. If Phases I through III show the investigational new drug to be safe and effective, then the pharmaceutical company will file a New Drug Application (NDA). The NDA includes both the results of the first three trial phases and data on how the drug is manufactured (Frank & Hargreaves, 2003; Lipsky & Sharp, 2001;