Guarantee of Safety
All prescription drugs manufactured in the USA undergo rigorous testing by the Federal Drug Administration (FDA) before they are authorized for sale. The developer must demonstrate that any proposed new drugs are safe for human consumption and perform with minimal potential side effects to human beings. This is a process that can take up to ten years and involves trials that cost many millions of dollars. These trials start with animal testing and progress to limited trials on human volunteers that must demonstrate the claimed benefits of the drug.
After establishing the safety and confirming the therapeutic benefits of the new formulation, the developer must then demonstrate to the FDA that the manufacturing facilities and quality control procedures are up to a very high standard. The developer must have Quality Control procedures in place at the manufacturing facility that guarantee formulations free of contamination or variance from the drugs submitted for test and used in human trials.
The developer is usually granted patent protection for the new drug and sells it as a brand name formulation for the life of that patent. This is a basic overview of a very involved process that was established to ensure that the highest possible safety standards are followed before new pharmaceuticals can be sold to the public.
After the patent expires, other manufacturers can to apply to the FDA for permission to produce and market the formulation. These generic versions of the original drug do not have to undergo the rigorous testing procedures followed by the developer, before marketing. This allows the generic versions to be sold at far lower costs than the original version.
These generic drugs must be the exact bio-equivalent of the brand name formulation. Generics must also be manufactured in facilities that guarantee the same quality as the innovator drugs before the FDA gives approval for sale.
Generic drugs save consumers more than10 billion dollars per annum at the retail level alone.
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