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  5. Lynn Yao, M.D. - Transcript
  1. Regulatory Science in Action

Lynn Yao, M.D. - Transcript

Developing safe and effective drugs for children, pregnant and lactating women

Dr. Yao: My path to the FDA has been one of, I think, great luck, great opportunity. After spending many years in clinical and academic medicine, I decided it was time to take a switch and look at public service. And so, I joined the FDA in 2008.

When I heard about the position in the Division of Pediatrics and Maternal Health, I thought, what better job could I ever have, you know, in this world.

Text File:

Lynne Yao, M.D.


Division of Pediatric and Maternal Health

Office of New Drugs

Office of Drug Evaluation IV

The reason that this division plays an important role in the overall development of drugs is because often, children, pregnant women and lactating women don’t necessarily get specific drugs developed for them. So, we work to help, when there’s a need, to get those drugs developed and important safety information labeled.

A pregnant woman on average will take 2 to 3 medications during their pregnancy. And there are changes that occur during pregnancy that have major impacts sometimes on whether a drug can be effective or safe.

It might have impacts on the developing fetus. The drug may also have a different metabolic path. It may be absorbed more readily, or it may be removed from the body differently while a woman’s pregnant. So, this special time in a woman’s life is important to consider.

It’s been recognized for many decades that children aren’t just little adults. Growing up is a lot more than just getting taller. Growing up means a lot of changes to the body that can have great impacts on the actual effectiveness of a drug and also the safety of a drug.

Prior to about the late 1990s, there were very few drugs that were developed for children. Over 80% of the drugs that were developed had no specific pediatric labeling or safety information.

And now, we have over 680 drugs labeled with pediatric specific information, which means that the total now in terms of labeling is less than 50% without pediatric information.

We are very proud of the work that we’ve done for children, pregnant women and lactating women, but there’s still more work to be done.

For example, pediatric cancer drugs and drugs used in newborns and premature infants pose an especially difficult problem in terms of studies. So, we would really like to improve on the number of products we have labeled in those specific conditions.

I jumped at the chance to work in the division, and it’s been a wonderful experience, very fulfilling to work on behalf of women and children, to help them lead healthy, productive, happy lives.

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