FDA Highlights Regulatory Science in Outreach to Public

Posted 17 September 2012 | By Alexander Gaffney, RAC 

"When someone uses the word 'science,' you might think of chemistry, biology, or physics, to name just a few fields," writes the US Food and Drug Administration (FDA) on a new webpage aimed at the general public. "You probably wouldn't think 'regulatory science.'"

That's something FDA hopes to change, the agency writes.

FDA officials are now touting the impact of regulatory science to the public, hoping to make consumers more aware of the complexities of regulating products and how agency initiatives stand to benefit consumers both now and in the future.

Writing on the "Consumer Update" webpage, "Why You Should Care About Regulatory Science," FDA notes that consumers may not think about regulatory as a scientific field. Most people instead think of the scientific fields of chemistry, biology and physics.

Which is a shame, given the field's outsized impact on the average consumer's daily life, says FDA Commissioner Margaret Hamburg.

"The breadth and scope of FDA's regulatory oversight is extraordinary, touching the lives of every American, through the food we eat, the medicines we take, and the medical devices we use," said Hamburg. "As new discoveries yield increasingly complex products, the agency must be able to make science-based decisions that result in sound regulatory policy."

What is Regulatory Science?

The chief role of regulatory science is bridging the gap between research and the delivery of safe and effective products to patients, explains FDA, applying other scientific disciplines to assist in the expeditious and accurate assessment of products.

While consumers benefit from the impact of regulatory science currently, future products will present new challenges and benefits as well, the agency says. Among those challenges: personalized medicines and medical countermeasures to assist in biodefense measures, both of which stand to revolutionize broad segments of the life sciences sector.

Personalized medicine, for instance, will see patients benefit from tailored treatments based on a patient's unique genetic information. This might allow for more medicines to reach patients based on the knowledge that while a drug could have dangerous side effects in one patient population, it could be life-saving in another.

Similarly, while biodefense measures will hopefully lead to a safer country, overcoming the hurdles of the initiative using regulatory science measures could lead to new manufacturing technologies for vaccines, new rapid testing methods, new ways to prolong the shelf-life of medicines and new methods of drug administration.

"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.

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