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A Pill Is Born

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

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.

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.

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