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A Pill Is Born

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

Advisory Committees continued...

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.

The FDA also has to approve a drug's brand name, which the drug maker invents. A brand name can't be misleading, self-promoting, or too similar to an existing drug name. A name like "Curezital," or "Lipitar" would never be allowed.

If I'm approved, I'll be sold as Nupil® (noperalate).

I'm really excited for that day. Hopefully I won't have too long to wait. The drug maker's factories are poised to swing into production; ad campaigns are prepared; and legions of salesmen are ready to fan out across the country as soon as the approval letter arrives.

The Rest of the Story

There's one last thing I want to mention before you go. My story won't necessarily end with approval and marketing. The drug maker and other researchers will keep on studying me. Someone may see a new use for me, in which case I'll have to go through the approval process again to be marketed for that use. For instance, drugs first developed to treat a certain kind of cancercancer have later been put to different uses. "There are many cases in the development of cancer drugs where companies will be studying new indications throughout the life cycle of the drug," PhRMA's Goldhammer says.

Of course, you also know that several drugs have been pulled off the market recently because of safety problems. Others have had special warnings added to their labels. Constant testing and careful attention to reports from doctors and consumers using prescription drugs sometimes uncovers problems that can't be ignored.

Nevertheless, I believe I'll end up helping millions of people for many years, until a better treatment comes along to replace me.

Wish me luck!


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