¶ … Drug Development (From Nature to the Market)
The process of drug development is a complex one. The pharmaceutical industry is required to adhere to strict governmental regulations, set out by the Food and Drug Administration (FDA), which involve numerous phases of testing and clinical trials, close monitoring of the drug's effects on users, its stability, dosage forms (the preparation), and so on. This paper will describe the drug development process, as it proceeds from nature to the market.
Drugs that eventually make it to the marketplace can come from a variety of sources -- plants, animals, microbes, synthetic chemistry, biotechnology, and even modified molecules. Years of research and billions of dollars are invested by pharmaceutical companies as they seek out new, potential drugs for the market. All of this effort has resulted in the FDA's approval of 1,200 drugs for the marketplace since 1950 (Munos 960). The "recipes" that have gone into producing these drugs are diverse, with some changing over time in order to meet with continuingly reassessed standards and updated regulations. While drugs have been produced by societies around the world through all history, the 20th century saw the beginning of a vast, federal initiative to provide oversight of the drug industry for the first time in the U.S. This began with the Food and Drug Act in 1906 -- the 1st law to be passed at the federal level regarding the regulation of drug standards. Various Acts throughout the 20th century amended the statutes contained in this early piece of legislation -- such as the F.D. & C. Act in 1938, the Durham-Humphrey Amendment in 1952, and the Kefauver-Harris Amendments in 1962 (all of which were passed to address issues that arose in the marketplace regarding safety of dispensation, safety of the drugs themselves, and authenticity of the drug's claims).
Today, new drugs must be sponsored in order to obtain FDA approval. Drug companies are typically the ones to sponsor new pharmaceuticals and as the sponsors, they are responsible for providing evidence that the new product is safe, effective, and does as is indicated by the product description. Moreover, as a result of the development of regulations in the industry, drug companies must also follow protocols regarding the manufacturing, packaging,...
This relationship has an effect on the payment rates that CMS sets. Higher cost pharmaceutical therapies are systematically reimbursed below acquisition cost (i.e., the payment system is biased against full reimbursement for higher cost therapies). Reimbursement compared to acquisition cost for the top IO pharmaceuticals by total expenditures indicates that 9 of the 10 are significantly under reimbursed." Clinical Trials Report: Congress established Medicare beneficiaries numbering 40 million with a prescription
38 per share on the company's common stock for the first quarter of 2005. The dividend is payable January 3, 2005 to stockholders of records at the close of business on December 3, 2004. Growth in the ZETIA and VYTORIN franchises are expected to continue. T There are currently several candidates in Phase III that Merck plans to file in 2005 as well as Type 2 diabetes treatment and three vaccines.
There are two constant irritations in U.S. pharma companies' relationships internationally: Some developing nations, such as India, Brazil and South Africa, are chipping away at the patent situation, trying to shorten the time until the drugs can be brought out in generic form. The U.S. has supported high prices as the cost for innovation. Since other countries are not playing along, this means that their citizens are benefiting from the innovation paid
For example, before its paten ran out, "the price of Schering-Plough's top-selling allergy pill, Claritin, was raised thirteen times over fives years, for a cumulative increase of more than 50%, over four times the rate of general inflation." In 2002, the average price of the fifty drugs most used by senior citizens was approximately $1,500 for a year's supply, and although this refers to what the companies call the
Sustainability in Pharmaceuticals Industry Ethical Pricing in the Pharmaceutical Industry The reality of medicine if the modern era is that resources must be allocated to help support the development of new pharmaceutical and in turn, there must also be a way to compensate those who devote their resources to help cure some of the preventable diseases that plague the modern age. The moral issue at stake here is distributive justice, and Rawls'
McKesson Corporation (Mckesson) is an American pharmaceutical distributor with operations mainly in the U.S. The firm has been in operation since 1833, and boasts extensive market share, robust financial strength, and strong market power. The firm has built strong relationships with its key stakeholders, which adds to its strengths. Nonetheless, limited diversification and market focus as well as the threats of competition, unfavourable regulatory changes, and counterfeits present significant concerns
Our semester plans gives you unlimited, unrestricted access to our entire library of resources —writing tools, guides, example essays, tutorials, class notes, and more.
Get Started Now