FDA in Sustained Push to Show Public Benefits of Regulatory Science

Posted 06 November 2012 | By Alexander Gaffney, RAC 

Can regulatory science-that is, the use of various scientific disciplines to make informed decisions about the safety, efficacy or quality of a particular product-ever be exciting to the average citizen?

Regulators with the US Food and Drug Administration (FDA) hope so, and are in the midst of a sustained public relations push to give the burgeoning field a bit more exposure and appreciation.

In a posting on 6 November, FDA's Susan Kelly, managing editor of consumer health information at FDA-better known as one of the public voices of FDA-explained that many consumers may take regulatory science for granted without ever having known that the field exists.

"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 pet," wrote Kelly. "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."

But while FDA's goals of protecting the public health are abstract, regulatory science is how aspirations get put into practice. "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."

Kelly's overview of regulatory science, while simplistic relative to most agency missives, is part of a broader trend at FDA, which has been moving aggressively in recent years to not only put new resources into regulatory science, but to market those advancements to industry and the public as well.

In a similar posting in September 2012, FDA tried to explain, "Why you should care about regulatory science."

In that posting, FDA wrote that consumers stand to benefit in new ways from regulatory science in coming years as innovative therapies start to come to market, such as personalized and genomic medicine.

"Advances in these areas will bring more innovative medical products to the market to help people with chronic and life-threatening diseases," explained FDA. "I think that's where the consumer would really appreciate or feel the investments that are made in this area," added Vicki Seyfert-Margolis, senior advisor for science innovation and policy.

In other various statements, FDA officials have touted regulatory science as one of the agency's top priorities, an area where global regulators can work together, a way to grow the economy, and something to be passed on to emerging regulatory bodies.

So maybe regulatory science isn't a household term yet, explains Kelly. "[But] 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."

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