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U.S. Department of Health and Human Services


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June 6, 2012: If FDA’s role is to ensure safe drugs, why are so many drugs recalled or have problems?

CDER Director

Everybody has to be aware that the premarket testing of drugs does not detect all the problems that can occur with a drug. It just can't. This fact is important for everyone who uses, dispenses, or prescribes medication to understand.

Why doesn't testing detect them all? Some events are just rare. They may occur in one out of 10,000 people. So, if you test 5,000 people during a drug’s development program, you probably won't see it. Even if you test 10,000, you may not see it; or if you see it, you wouldn't believe it was related. However, when a drug reaches the marketplace, hundreds of thousands could be using it and previously undetected problems may be seen.

Some problems with drugs are caused by the way they're used outside of the parameters for which they're approved. Sometimes we encounter errors in the use of the drug; medication errors that were hard to foresee prior to approval. Maybe the name, even though we look at the names, was too close to another drug name, and once they get out on the market, they get mixed up.

A vigorous program is needed after drugs are marketed, to detect these safety problems and to correct them as soon as possible. We have a spontaneous reporting system through which people can report all these problems to the agency. We get a tremendous number of reports--about a half million a year.

To underline the importance of safety issues, our Safety First Initiative was established. The program ensures drug safety throughout the drug lifecycle by giving pre-marketing drug review and post-marketing safety equal focus. This calls for inter-office, multidisciplinary safety-issue teams to assess significant safety issues, recommend actions, and monitor sponsors’ activities.


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