FDA Approvals – A Challenging Task for Pharmaceutical Companies

Every pharmaceutical company manufactures endless number of medicines and vaccinations. But not every drug they produce reaches the end users; as it lacks perfection. To do a quality check and give an authenticity certificate there is the need for a centralized body; FDA (food and drugs administration) is one of them. The trust and reliability FDA approved drugs promise to the users are unmatched. It is however a tough task to pass the laid parameters and get an FDA approval, below given pointers explains why.

Expensive: When a pharmaceutical company decides to put forth any of its formulation for an FDA approval, it is also prepared to bear the cost of the approval which is expensive. Pharmaceutical manufacturers ultimately end up spending huge amounts of money in the research and development process. This investment cannot be fruitful unless the FDA approvals guidelines are met and to get a formulation tested by this body also requires financial investment. FDA performs numerous tests upon the submitted formulation and once the tests are successfully passed by their experts the certification is given. The tests are expensive and the concerned pharmaceutical company has to finance the testing part, thus the process becomes heavily expensive.

Lengthy procedure: The clinical trials of FDA go on for years, usually 5 years on an average. This is because the testing phase cannot be carried out back to back. This is so because FDA also tests whether the formulation has any reactions or side effects after it is consumed by the volunteers. They also need to make sure the formulation provides effective cure for the condition it promises to treat. Such observations require their own time and there cannot be any doubts left as once the formulation gets a nod, it can be produced on a mass scale and is understood to be safe for consumption. There are many aspects to be measured and checked without the FDA approvals standards can never be met; thus it becomes a lengthy process but the end results are worth the wait.

The parameters set by FDA are strict and completely based on quality check and testing. So if a pharmaceutical company spends huge amount of money in making a formulation and claims it is superior but fails to pass the FDA tests, it will be of no use. When it comes to food and drugs, the end consumers are huge and no risk taking can be afforded. Pharmaceutical manufacturers therefore do their own tests and quality check before they approach FDA to pass their product. In case a company constantly produces formulations that are constantly being rejected by the governing bodies; they can be black listed and even lose their license. Very few pharmaceutical companies manage to pass the FDA approvals and are presently able to provide effective cure for diseases that were once thought to incurable. It takes a lot of patience, quality research and development work for a pharmaceutical company to reach such a level.

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