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A Pill Is Born

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

The Review continued...

The reviewers don't have to rely entirely on the sponsor's interpretation of the data, either. Because they have access to all the study data, they can do their own analysis if they see fit.

"That is what makes the U.S. review system so unique," Kweder says. "No other countries do that."

The application also includes proposed label information: instructions on how to use me, what I'm supposed to do, and what side effects and safety issues I have. Often the FDA wants to tweak what will be printed on the label.

Advisory Committees

In some cases, but not mine, the FDA will convene an advisory committee. Clinical trials may reveal that there are serious risks to be balanced with the drug's benefits, or there may be doubt about whether the drug really works. "Even before the application comes in, we have some sense of what the studies show, and we know that this is going to be a close call," Kweder says. "Those close calls are a common reason to take something to an advisory committee."

An advisory committee may also be useful if a drug is controversial, or if it's so new that nothing like it has ever been approved before. The committee is made up of independent experts. Its recommendations are weighed seriously, but the FDA is not legally required to follow them.

Finally, every reviewer will write a report. A top official will consider the reviewers' recommendations and make a decision: "approved," "approvable," or "not approvable."

An approved drug has a green light to be marketed that very day. For an "approvable" drug, final approval may depend on the drug maker meeting certain conditions, such as providing additional data. A drug that's "not approvable" is essentially shot down.

In 2003, it took the FDA about 17 months, on average, to finish a review. But some drugs get a priority review. That's when there is an urgent need for it to reach patients as soon as possible. Many drugs developed to treat AIDS had priority reviews, for example. "For priority reviews, we have a six-month review clock," Kweder says.

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