Explain why there has been a reduction in the introduction of new drugs in the market.
The decrease in introduction of new drugs is attributable to Kefauver Harris amendments to Pure Food and Drugs act of the year 1962. These were the amendments which were passed by the congress in an emotional outcome of the tragedy which was caused by thalidomide. These amendments imposed stringent measures on drug companies to prove the efficacy and safety of the new drugs beyond any reasonable doubt. Consequently, about two to four more years are required to get the necessary endorsement for new drugs by the Food and Drug Administration. These stringent measures have also come with additional costs because of increased expenditures in research and development. In addition, the delay in FDA approvals has also made it difficult for drug manufacturers to anticipate market demand and the state of technology, consequently, delaying the process of churning out new drugs in the market.
Discuss the processes and stages of developing a new drug and bringing it to the market
The process of developing a new drug and introducing it to the market is long and expensive. It begins by deliberately modifying a natural product with desired therapeutic effects or with unintended establishment of beneficial effects in some compound. The compound is then tested on other animals or rodents. At this stage, specialists in biochemistry, biology and chemistry are involved. Chemistry experts are then allowed to engage in large scale manufacture of the drug, and if continuous testing continues to reveal significant therapeutic effects, extensive studies on toxicity begin. At this stage, this product is administered to monkeys or dogs in a similar way that it could be used with human beings, where thorough analysis is undertake to determine its toxic effects. If the product gives a promise on safety and efficacy, then it is administered to human beings under controlled trials by the principal investigators. If after several randomized clinical trials, the FDA gives a nod to the new drug, then the product can be commercially produced for marketing.
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