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    A Pill Is Born

    Let a new drug show you how it (and other drugs) came to be.

    I Got a Name continued...

    Seven years had passed since I was first noticed in the lab and chosen for development. A lot of time, brainpower, and money had been invested in me, but there was still a chance I might fail. Clinical trials are kind of like the Olympics. Often very promising athletes make it to the games but ultimately don't measure up. About four out of five drugs don't make it through clinical trials.

    Not everyone was cheering me on, either. Many scientists in the field were skeptical. They thought the early study results weren't convincing. By the time the phase II studies wrapped up, however, a lot of people were getting excited. It was clear I would go on to phase III.

    The final phase of clinical trials lasted four years. I had to be tested on thousands of people, and show beyond a doubt that I really worked and that my benefits far outweighed any potential problems.

    The Review

    So, that brings us up to date. A few days ago, my sponsor filed a "new drug application" with the FDA. That's a formal request for the FDA to review a drug.

    Like I said before, the drug company had to turn over every bit of information it had on me. That includes data from all the test-tube experiments, animal studies, and all the clinical trials.

    I was curious about how the review process works, so I asked Sandra Kweder, MD, deputy director of the FDA's Office of New Drugs.

    The FDA has many different experts on staff to review various parts of the application. They look at all aspects of it, not just the study data.

    "For example, there will be a chemist who is reviewing the entire manufacturing and quality control system," Kweder explains.

    Other ingredients will be mixed with me to make pills. Those ingredients have to be safe, too, and they can't react with me in a way that changes how I work.

    Then there are the other experts:

    • Physicians
    • Toxicologists
    • Statisticians
    • Microbiologists
    • Pharmacologists

    They're all looking for problems with the evidence my sponsor submitted. They sometimes ask for more data, for example, from a study done over a longer time or one that includes more test subjects. I'm confident we have given the reviewers all they need, though. My sponsor has kept in touch with the FDA throughout the clinical trials, and even asked how to design studies to best meet the FDA's requirements.

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