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A Pill Is Born

Let a new drug show you how it (and other drugs) came to be.
By
WebMD Feature
Reviewed by Louise Chang, MD

I'm just a pill. Yes, I'm just a pill. And I'm sitting here ...

Oh, hi. My name is Nupil. I'm a new drug, or at least I hope to be. Right now, the FDA is deciding whether to approve me. See that big office building? That's the Center for Drug Evaluation and Research. It's as important as it sounds. The fate of all new medicines that want to be sold in the U.S. is decided here.

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Birth Control and Depo-Provera

Birth control is a way for men and women to prevent pregnancy. There are many different methods of birth control; some types also protect against sexually transmitted diseases, or STDs. Depo-Provera does not protect against STDs. Depo-Provera is a birth control method for women. It is made up of a hormone similar to progesterone and is given as an injection by a doctor into the woman's arm or buttocks. Each shot provides protection against pregnancy for up to 14 weeks, but the shot must be received...

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Inside, FDA reviewers are carefully examining all the information that's known about me and talking it over together. They sure are busy. There are more than 100,000 pages of data, and it will take a team of reviewers several months to review. I guess I'll just have to sit here and be patient.

How did I end up here? Why, I'm glad you asked. That's an interesting story.

A Molecule Stands Out

About 12 years ago, I started out as a molecule, one of thousands researchers created in a laboratory. The scientists screened us, one by one, looking for some special properties. I was added to some cells in a test tube to see what I would do.

It was a long time ago, but I remember I liked almost everything about those cells, except for one awful little enzyme -- an enzyme that could make people sick. That enzyme really annoyed me, so I blocked its production, but left everything else alone. Well, the scientists were plenty pleased. I only did what came naturally to me, but now I know it was exactly what they were hoping for.

I didn't have a name yet, just a number: ABCD-523.

The Testing Begins

The scientists then started testing me in laboratory rats. The purpose of this was to see if I did the same thing in live animals that I did in the test tube. They also wanted to know if I had any toxic effects. They measured how I was absorbed and passed though the animal's body.

As Alan Goldhammer, PhD, associate vice president of regulatory affairs for the Pharmaceutical Research and Manufacturers of America (PhRMA), told me, "It's easy to identify lots of things that work inside a test tube." The challenge is finding something that works in a living body.

The results of the experiments were good. It's pretty rare for that to happen. Only one in 50 promising compounds will pass these tests. The vast majority don't work as expected, or they prove to be too toxic.

Meanwhile, researchers studied how I could be made into a pill. They wanted to make sure I wasn't too fragile -- that I could exist within a wide range of temperatures without degrading. They also looked at how difficult it would be to manufacture me on a large scale. It seems I'm not fussy about the weather, and I'm not impractical to make in bulk.

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