National Press Club

FDA Commissioner Calls for More, Better Regulatory Science

October 6, 2010

Margaret Hamburg

Margaret Hamburg

Photo/Image: Noel St. John

Regulatory science -- the bridge between scientific developments and consumer products -- is"not as robust as it needs to be" in the U.S., the head of the Food and Drug Administartion said at a luncheon Oct. 6.

Margaret Hamburg said regulatory science has been "under appreciated and under funded," but she is "guardedly optimistic" that funding will increase in the 2011 budget.

The FDA commissioner issued awhite paper, "Advancing Regulatory Science for Public Health," at the luncheon.

"I hope the report will persuade you that regulatory science really matters, and the time to act is now," she said.

Regulatory science is the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products. These products, Hamburg said, account for 20 to 25 percent of the value of products consumers buy, from food to medicine to toothpaste.

She cited the example of research to improve the label for a coagulant for which the optimal dose could vary by the patient's age, diet, other medicine and genetics. Research could develop a genetic test to assist medical providers in determining the optimal dose, she said. She also described work with the National Institutes of Health to develop an artificial pancreas for treatment of type 1 diabetes and work with the Department of Health and Human Services to develop counter-measures for bioterrorism and naturally occurring diseases.

Hamburg said there's a need to effectively translate the billions of dollars spent on medical research -- $80 billion in private expenditures and $30 billion in NIH funding in 2008 -- into treatment. She described a troubling gap between advances in science and patients' care. Regulatory science is that bridge, she said.

She underlined the importance of attracting outstanding scientists to the FDA and retaining them by offering interesting work, career ladders, and more opportunity for professional exchange. The FDA has developed a fellowship program to bring scientists into the agency early in their careers.

Asked to give advice on personal health steps, she said "Do what you mother always told you." Her mother, also a medical doctor, smiled from her seat at the head table.

-- Lorna Aldrich,