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The Drug-Making Process

Why it often takes 10 years to launch a prescription drug

Determining an accurate timeline or cost for developing a new medicine is difficult. The 128-month estimate at right is based on a 2016 study by the Tufts Center for the Study of Drug Development in Boston. It is considered the most comprehensive report on the subject to date, though some disagree with aspects of the study.

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Initial Research

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31 months: Scientists first study the disease to find vulnerabilities on which to focus. From there, they seek a chemical that attacks that weakness.

First Trial

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20 months: Once researchers have a medicine they believe will work, it is tested on 20 to 80 healthy volunteers to
verify its safety. This is called a phase 1 clinical trial.

Second Trial

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30 months: Roughly 60 percent of phase 1 trials proceed to a phase 2 trial, which usually involves 100 to 300 people with the disease. The capabilities of the drug get tested at different dosages.

Third Trial

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31 months: In a phase 3 trial, 1,000 to 3,000 volunteers with the disease are tested and watched closely both for efficacy and side effects.

Government Approvals

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16 months: If trials succeed, a new-drug application is filed with the Food and Drug Administration. The FDA needs up to a year to make an approval decision.

Drug Launch

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Years 1–3: The drug is put on sale, often with a large marketing campaign. The FDA may require a phase 4 trial to examine additional risks. The company must report on any adverse reactions seen by doctors.

Year 4 and Beyond

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 Drug companies manage a medicine like any other product, adjusting the price, creating new promotions, seeking new customers and researching new uses for it. As the patent expiration date gets closer, companies create plans for keeping sales strong after competitors introduce generic versions.

Illustrations by Andrew Roberts 

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