By: Susan Kelly
I’m a relative newcomer to government work, joining FDA about 18 months ago after decades of being a journalist. My job is to assign, write and edit FDA Consumer Updates, news stories posted on fda.gov that are 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 that 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 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.
FDA has a huge impact 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, the foods and medicines you give your pets. FDA’s job is to make sure that products like these, and many, 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 FDA collects the scientific evidence it needs to determine if a regulated product will actually make your life better. It’s how FDA collects the scientific evidence it needs to ensure that the foods you eat at home or in restaurants are safe to eat. (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 the need to test 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 for their 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.
Susan Kelly is the managing editor of Consumer Health Information at FDA.