Healthy Skepticism Library item: 16512

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Publication type: news

Grant B
More regulatory science: FDA chief
The Scientist.com News Blog 2009 Sep 17
http://www.the-scientist.com/templates/trackable/display/blog.jsp?type=blog&o_url=blog/display/55984&id=55984

Full text:

The US must bolster study on how to best craft regulations that bring drugs, medical devices and vaccines to market, the commissioner of the US Food and Drug Administration stressed in a speech delivered yesterday (September 16th) in Philadelphia.

Margaret Hamburg, the former New York City health commissioner who was named FDA commissioner earlier this year, was speaking at the annual Regulatory Affairs Professional Society conference to approximately 850 representatives from pharmaceutical companies, biotechs, and medical device manufacturers.

“Just as biomedical research has evolved in the past decades, regulatory science — the science and tools we use to assess and evaluate product safety, efficacy, potency, quality and performance — must also evolve,” she said.

Hamburg added that too little attention and resources are paid to regulatory science as a discipline that can help the FDA protect and benefit American citizens. “Our efforts will be seriously compromised if we don’t significantly increase the sophistication of our regulatory science soon,” she said. “A strong and robust field of regulatory science is essential to the work of FDA, and I believe it represents an important driver of our nation’s health.”

As Hamburg was addressing an audience of regulatory professionals, she gave only a cursory definition for regulatory science. This left me wondering: What the heck is regulatory science?

For the answer, I turned to Alan Moghissi, the president of the Institute for Regulatory Science, a non-profit that advises universities, Congress, and state and local governments on matters of regulatory science.

“Regulatory science is a unique application of science, at all levels, to the societal decision process,” Moghissi told The Scientist.

He explained that regulatory science involves taking existing information or data and using it to hone and develop effective regulations, laws and judicial systems. When these social or industrial parameters are set using ideals or emotions rather than scientific inputs, Moghissi added, the public often winds up misled. “The moment you bring in societal objectives, as good as they may be, they mess [the regulatory or legal process] up.”

Moghissi noted that the problem extends beyond FDA and into other agencies tasked with developing meaningful and effective regulations. “I believe there’s a lack of recognition of the significance of regulatory science,” he said.

Indeed, there seems to be only a select few academic programs that specialize in turning out regulatory scientists. One such program, at the University of Southern California’s School of Pharmacy, bemoans the lack of regulatory science practitioners and uses the need as a recruitment device. “Industry and government cannot find sufficient numbers of skilled personnel to meet demands,” the program’s website reads. “Our program can help you get to the forefront, to become a leader in this emerging profession.”

Frances Richmond, director of the USC program, said that beyond being under-appreciated in terms of its importance to policy and regulation making, regulatory science is not a career “that people even recognize.” Richmond told The Scientist that improving the practice of regulatory science hinges on improving how we train its practitioners. “The investment should be more on the education side,” she added.

During her speech, Hamburg also pointed to the essential role that regulatory science plays in translating biomedical research discoveries to the clinic. “The goal is to place the emerging, very promising areas in science and technology, such as genomics and personalized medicine, the development of stem cell therapies and therapies that harness the power of nanotechnology fully at the service of public health,” she said.

Both Moghissi and Hamburg indicated that increased investment in the field of regulatory science is crucial to boosting sound rule-making in the drug and medical device industry. “Our nation has invested billions of dollars in biomedical research, an effort that’s indispensible for medical progress. But this research will not result in new therapies and cures unless it’s married to a robust investment in regulatory science,” Hamburg said. “We cannot afford to have a muscular investment in fundamental research and discovery with only a scrawny counterpart in regulatory capacity.”

“Some of the money that is being spent on R&D ought to be redirected with emphasis on regulatory science,” Moghissi concurred. “Maybe more resources would attract more people to attend to it.”