New Drug Development Process

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Concise Explanation of the New Drug Development Process in the U.S.

Pharmaceutical companies hire expert chemists who synthesize chemicals day after day, hoping that one of them will be the next wonder drug. After a chemical which is a potential new drug is synthesized, it typically undergoes several years of animal testing and other testing in the laboratories of the pharmaceutical company. If the company is convinced that they have a potential new drug, they will submit an Investigational New Drug (IND) application to the Food and Drug Administration (FDA). If the IND application is approved, the drug will go through clinical trials to prove that it is safe and effective. There are 3 stages of clinical trials which a drug must complete successfully. Stage 1 involves less than 100 people, Stage 2 a few hundred people, and Stage 3 a few thousand. Upon successful completion of Stage 3 the pharmaceutical company will submit a New Drug Application (NDA) to the FDA. An NDA contains tens of thousands of pages of data. The FDA will review the application. If approved, millions of people may take the drug. The pharmaceutical company is required to continue to gather safety data on the drug. If it turns out later that the drug was not as safe as was previously thought, the FDA may put strict requirements and limitations on the use of the drug, or even revoke the right to sell the drug in the U.S.

The Pharmaceutical Research and Manufacturers of America organization says that it takes an average of 12-15 years to discover and develop a new medicine. Only 1 in 1000 even make it to clinical trials. And only 1 of 5 which make it to clinical trials actually make it to market. This process makes the R&D cost be about $500 million for a new drug. (2001)