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Susan Kelly

FDA Compliance

Regulatory Science Is Not Boring

Seriously. Really. I’m not kidding.

Published: Friday, November 9, 2012 - 12:37

I’m a relative newcomer to government work, having joined the Food and Drug Administration (FDA) about 18 months ago after decades of being a journalist. My job is to assign, write, and edit FDA consumer updates, which are news stories posted on www.fda.gov designed to give consumers important information in language that’s easy to understand—not too technical or bureaucratic.

To endear myself to my new colleagues, I decided to write about anything we saw as boring, leaving them to write about the hotter topics. I’m not easily bored, so I thought this would work as a noble gesture.

Even with this resolve, my heart sank when I was asked to write about regulatory science—one of the FDA’s highest priorities. Do you remember the character Chandler Bing from the TV show Friends? I could hear his voice in my head: “Could this be more boring?”

But I resolutely set about my task, and five consumer updates later, I’m here to tell you that regulatory science is not boring. Not even close.

The official definition: “Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, effectiveness, quality, and performance of FDA-regulated products.”

Ok. Put down the remote and give me a minute.

The FDA has a huge effect on your daily life. Think about the foods you eat, medicines you take, vaccines your kids are given, the medical devices as commonplace as BAND-AIDs and toothbrushes and as complicated as an artificial heart, even the foods and medicines you give your pets. The FDA’s job is to make sure that products like these, and many more, do what they’re supposed to do—and do it safely.

Regulatory science is the proof that’s in the pudding, so to speak. It’s how the FDA collects the scientific evidence it needs to determine if a regulated product will actually make your life better. It’s how the FDA collects the scientific evidence it needs to ensure the foods you eat at home or in restaurants are safe. (How they taste is not our problem.)

Regulatory science identifies and tracks nasty bacteria that contaminate food. It creates genetic tests to determine if medication could work for you specifically—not just for people who are like you in some way. It puts human cells on a computer chip that mimic the function of organ systems, thereby possibly reducing testing new drugs on animals.

It’s the virtual family—a scary-looking group of computer models that scientists can use to see what medical devices would work on individual patients.

I especially liked meeting the scientists. Some of them struck me as a bit eccentric, as you might expect. Others are shy and reticent. What they have in common is a genuine commitment to make the world a better place—a safer place.

So the next time that you read the words “regulatory science,” take a second look. The work that goes on under that banner could save your life someday.


About The Author

Susan Kelly’s picture

Susan Kelly

Susan Kelly is the managing editor of the U.S. Food and Drug Administration’s Consumer Health Information.


Regulatory Science Is Not Boring

These days, the field requires expertise from scientists in a variety of disciplines, including physicists, life scientists, chemists, and engineers.