How does a drug become passed by the FDA?

what are the stages involved in the process of FDA approval of medications, stage 1, 2, etc, Say a drug was created that was effective in treating a disease, how long would it take to get FDA approval

1 Answer

  • Sage
    Lv 6
    1 decade ago
    Favorite Answer

    It takes years to obtain FDA approval, and hundreds of millions of dollars. The basic process is this. A pharmaceutical manufacturer conducts basic research into a potential drug, performing laboratory analysis of the chemical and biological characteristics of the drug that might indicate that it has a useful effect in treating a medical condition. Most potential new drugs are dropped at this stage, and no further research is conducted, because they do not appear to be promising. The more promising drugs go to stage 2 -- animal experiments. Animal experiments are intended to determine both efficacy and safety. Does the drug do what it is intended to do? Does the drug have harmful effects? A number of potential drugs are dropped at this stage, either because they don't appear to be particularly effective, or because they may be dangerous. Drugs that advance past this stage go to stage 3 -- limited human experiments. This requires FDA approval, based on data submitted to the FDA from stage 1 and stage 2. If the FDA consents, limited human experimentation is conducted on a relatively small number of volunteers. Once again, the researchers are attempting to determine efficacy and safety. The data from this limited human experimentation is submitted to the FDA. If the data are promising, the pharmaceutical manufacturer will ask the FDA for permission to go to stage 4 -- a full placebo-controlled double-blind test on hundreds of volunteers who are suffering from the condition that the drug is expected to treat. The FDA must approve the experimental protocols. Basically, this stage involves a number of volunteers, some of whom receive the drug and some of whom receive a placebo (a harmless ingredient, which cannot possibly cure the condition). The doctors administering to the patients do not know whether their patients are receiving the drug or the placebo. This is intended to eliminate any subjectivity in the analysis of safety and efficacy -- only a few people know which patients received the drug and which patients received the placebo. This study can take several months to conduct, and at least that long to analyze. After this study is conducted, the researchers analyze the results and report the results to the FDA. If the results indicate that the drug is safe and efficacious, the FDA will approve the drug for marketing and distribution.

    This whole process typically takes anywhere from 2 to 6 years to complete. A study at Tufts University estimated that the average cost of bringing a new drug to market was about $800-$850 million.

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