Orphan Drugs

Orphan drugs refer to those medicines that are intended for use in the diagnosis, prevention or treatment of debilitating or life-threatening rare diseases. The reason for the name 'orphan' stems from the fact that they are made in very little quantities as the pharmaceutical industry has very little interest in them. In an ever evolving and developing market environment that is extremely competitive, a pharmaceutical company builds its marketing strategy based on the conditions prevalent in the patient population. Hence, very little interest is shown in the population having few or even rare diseased conditions.

In the year 1982, the US FDA established the Office of Orphan Drug Development, with the objective of encouraging pharmaceutical companies to work on cures for rare disorders. Most Orphan Drug manufacturers avail tax reductions and exclusive rights in the form of patents. By definition, an orphan drug is a drug made for a disease condition that affects less than 5 per 10,000 people of a population.

People in the Third World countries do not have access to quality healthcare, drugs or vaccines that is so commonly available in the developed ones. Numerous obstacles are encountered by the few pharmaceutical companies that specifically focus on manufacturing orphan drugs.

Some of the most common obstacles encountered are:

1. Increasing cost of R & D (research and development) projects

2. Complicated legislations and unfavorable regulatory environment for drugs

3. Streamlined and optimized product portfolio of each pharmaceutical company.

Hence, the potential market for such scarce and rare drugs is very small and one that is quite challenging.Regulations would be required to further promote the manufacturing of orphan drugs and concessions would be needed in order to make them affordable to those suffering from rare health conditions. Increased awareness needs to be created regarding the need for such medications so those few suffering from these conditions would get that much needed help.

Pharmaceutical manufacturers would need to make internal preparations by putting together a compliance program with appropriate programs and controls in place so that an accurate estimate can be made before the commercial launch of such a product. External factors such as understanding the disease, cost of the drug, drug distribution and availability will all play a key role in launching such rare drugs.

Medical writer at a Leading Healthcare and Medical Marketing Firm.Check out his blog a Medical Mantra, a pharma blog with a difference.

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