FDA Prepares for Nanomedicine Revolution

June 21, 2011 -- New technology now makes it possible to create atomic-scale drug particles, diagnostic tools, and biological medical devices -- and the FDA is struggling to regulate the fast-growing field.

Noting the "critical need to learn more" about the impact of nanotechnology on medicines and medical devices, the FDA has issued a warning that it intends to regulate the field -- and has asked for help in understanding the impact the new technology will have on FDA-regulated products.

It's a welcome development, says nanomedicine developer Gang Bao, PhD, director of the Center for Pediatric Nanomedicine, a joint project of the Georgia Institute of Technology, Emory University, and Children's Healthcare of Atlanta.

"It is a great thing that FDA now pays attention to nanotechnology," Bao tells WebMD. "We can always publish scientific papers, but what we really want to do is have nanomedicine used in the clinic: for drug delivery, diagnosis, or treatment using nanomachines. Without FDA approval we cannot do that. So therefore this is a very important advance."

Nanotechnology already is a trillion-dollar industry spanning fields from agriculture to product packaging. It springs from new technology that makes it possible to manipulate matter at the atomic scale. The application of this technology to medicine is truly revolutionary, says Jamey Marth, PhD, director of the Sanford Burnham Center for Nanomedicine at the University of California, Santa Barbara.

"It will be comparable to what occurred 50 or so years ago when Watson and Crick discovered the structure of DNA and its role in biology," Marth tells WebMD. "We are going to witness a huge increase in the understanding of disease and in the ability to treat, detect, and ultimately cure disease with nanomedicine."

What Is Nanomedicine?

It's difficult, but important, to grasp the scale of the nano world. A nanometer (nm) is a billionth of a meter. A single sugar molecule is 1 nm in diameter; the DNA helix is 2 nm in diameter.  A typical virus is 75 nm in size. A red blood cell is 7,000 times larger than a nanometer.

"Why this size? Inside a living cell we have proteins, we have DNA molecules, etc., all on a nanoscale," Bao says.

"Just a few decades ago, a computer used to be the size of a room," says Marth. "Now everyone has a laptop. It's the same thing in biology. We are seeing the miniaturization of biology, which will rapidly change the way we do research and develop drugs."

By allowing scientists to take such a close look at biological processes, nanotechnology offers new tools to understand what causes disease. We've been able to learn a lot by cracking the DNA code. But genetics doesn't tell us all the biology we need to know.