Orphan Drug Market Development And Manufacturing Of Products

Imagine this: you are tragically diagnosed with a chronic life-threatening illness. Your only hope to survive is through medication to treat your disorder. The medicine is pricy but you can work out the costs each month. One day, you go to fill your prescriptions and realize the cost of a $13 pill has jumped to an astounding $750. You need this patented medication to survive and to afford it you end up losing your home, filing for bankruptcy, and sleeping in your car. This story sounds fictional but it is the reality for many Americans who can no longer afford their grossly overpriced medications.

Although the FDA prolongs this process for safety concerns, I personally feel that they should be able to expedite their approval. The reason for expedition is because more and more people are being diagnosed with multiple health issues. Some people are more desperate then others and feel they can benefit from the drug as it is. Therefore, if a person wants to take a drug that has not been approved yet, then they should be able to

This topic is important because I stated before there are other human beings out there that are dying and instead of getting the treatment they need they are forced to live with the disease until they die, and pharmaceutical companies are now charging an arm and a leg. Take the medication Daraprim, a medication that is given to AIDs patients it used to cost a dollar a pill something that most individuals could pay, that was until 2010 when the company CorePharma bought the rights and started charging 13.50 a pill. (CNN Money) This amount is still semi reasonable for individuals in America, while those in Africa well if they couldn’t pay for it before then they certainly won’t be able to buy it now. (CNN Money) CorePharma was once lead by Martin Shkreli the man who is now awaiting sentencing because he was charged with fraud and conspiracy (Business Insider). This same man raised the medication again from thirteen dollars and fifteen cents up to seven hundred fifty dollars a pill, that is a five-hundred percent increase. (CNN Money). They then dropped the price in half so now pill costs

Improvements in health care and life sciences are an important source of gains in health and longevity globally. The development of innovative pharmaceutical products plays a critical role in ensuring these continued gains. To encourage the continued development of new drugs, economic incentives are essential. These incentives are principally provided through direct and indirect government funding, intellectual property laws, and other policies that favor innovation. Without such incentives, private corporations, which bring to market the vast majority of new drugs, would be less able to assume the risks and costs necessary to continue their research and development (R&D). In the United States, government action has focused on creating the environment that would best encourage further innovation and yield a constant flow of new and innovative medicines to the market. The goal has been to ensure that consumers would benefit both from technological breakthroughs and the competition that further innovation generates. The United States also relies on a strong generic pharmaceutical industry to create added competitive pressure to lower drug prices. Recent action by the Administration and Congress has accelerated the flow of generic medicines to the market for precisely that reason. By contrast, in the Organization for Economic Cooperation and

Technical risk, a large portion of all development costs are spent on drugs that never reach the market.

Prescription drug prices are on the rise in the United States. Currently, the United States does not implement a price control on prescription drugs. Every day the supply and demand for prescription drugs fluctuates. Pharmaceutical companies produce drugs that are necessary for survival. Therefore, it is necessary for research and development to continue in the United States. Those suffering the effects of exorbitant prices must do so until a generic form of a prescription drug is produced. Once approved by the FDA, new drugs will make their appearance on the market and patients will no longer suffer financially. Until then, it is necessary for pharmaceutical companies to price their drugs based on the idea of supply and demand. This produces the profit used to fund research. Price controls discourage innovation. If a price control were set in place, of course the price of prescription drugs would decrease. However, the development of new drugs decreases with it. Today’s generation would benefit from lower prices, while future generations would suffer from the loss of drug innovation.

Anyone who has purchased prescription medications has probably wondered why they cost so much, and rightfully so. Medication prices in the United States have been on a steady increase for decades, however, prices have been drastically increasing as of recent. Pharmaceutical companies have tried to justify these price increases due to the demand, the high cost of research, and the high costs of development and approval. Notwithstanding, the extent to which the prices have increased is not justifiable. Americans should be against these high medication prices and take action because pharmaceutical companies are taking advantage of our health care system in order to capitalize from the sick. In order shed some light on this issue, we must examine the magnitude, scope, and consequences of these rises in price.

Moreover, patients often have less knowledge than the prescriber does about the appropriateness of the drug, where it can be very misinforming for the consumer. Lastly, drug efficacy is a problem in all contexts. Since stakeholders are likely, less informed than manufacturers it causes both the consumer and prescriber to depend on the manufacturer for information of the effectiveness of the drug (Bennett, Quick, Velasquez, 2016).

There have been 5,000 rare diseases that have been identified. The disease is considered rare in the United States if less than 200,000 people have it. The pharmaceutical industry will not develop a cure for the disease since it does not affect most of a population. For this reason, Congress passed the Orphan Drug Act (ODA) in 1983.

In pharma industry the raw materials mainly consist of organic chemicals. The need of different organic chemicals depends on the chemical formulae of drug. Pharmaceutical industry depends on various different organic chemicals for the production of end drugs. The chemical industry itself is very competitive and also very fragmented because their products (organic chemicals) are standardized and steps to produce them are also standardized. The chemicals used in pharma industry are commodity as pharmaceutical companies do production on economies of scale to lower the cost. The suppliers have low bargaining power because companies can switch to a new supplier without incurring a high cost. But there is a threat from supplier if it decides to go for forward integration and become a pharma industry

One factor that must be considered is that the drug had not yet been approved by the FDA, but was in phase III trials. Historical data shows that 65% of drugs in this phase eventually get approved for sale to the market. It was felt that approval of the drug would occur late in 1998.

There is also a slight issue between consumer and manufacturer as both are in dis-agreement of keeping up with cool chain requirements. This is an operational issue as from an employer and employee perspective their always needs to be a good relationship between manufacture and consumer as the pharmaceutical products needs to have high level in security measures and the manufacturer intrusts the consumer with his products. This is related to another issue found with theft in organisation MISHAIR.

The research and development of the pharmaceutical industry is very important as the industry relies on it to develop new products to maintain and sustain the growth of the industry (ALRC 2014). According to the Australian Government Law Reform Commission, every year, the total spending in research and development in pharmaceutical industry, which includes drug discovery, pre-clinical testing and clinical trials on drugs is around $300 million (ALRC 2014). Mergers and acquisitions are intensifying in the global pharmaceutical industry, especially over the last 10 years. With factors like exorbitant research and development costs, the relatively shorter product life cycles, and the rarity of discovering a new life-changing drug acting as catalysts, leading pharmaceutical companies now have more cause to step out and look for external collaboration. This results in an increasing number of smaller biotechnology companies merging with bigger pharmaceutical companies (The

This report provides an analytical strategic review of the global pharmaceutical industry; its origin, evolution,

activities and tactics such as sampling and sales force promotion [3]. Whether a brand manager is using right promotional tools, whether 4P`s (now 7P`s are considered) are linked to each other and with product strategies for the two main objectives that includes [3]:  To Generate Prescription  Make the product reach the patient They can be said as Product chain and Prescription chain 1.1 The Product Chin This starts from selection of molecules and ends in the hands of patient. This chain is somehow intensive as it starts from the selection of molecules, then molecules are critically screened, after the screening of molecules the source of raw material is identified then the pilot batch manufacturing process starts at this stage pricing strategies and clinical trials are worked out. Once the pilot batch is manufactured then it starts with the commercialization of product, after commercialization product goes to distribution house and then it reaches the retailers. After patient’s diagnosis by doctor, patient purchases that product from retailer [4]. 1.2