Analysis: FDA comes up short on nanotech

By STEVE MITCHELL, UPI Senior Medical Correspondent  |  Oct. 5, 2006 at 5:28 PM
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WASHINGTON, Oct. 5 (UPI) -- A former high-ranking Food and Drug Administration official says the agency lacks the funding and legal authority to adequately regulate drugs, medical devices and other products that incorporate nanotechnology.

"The most fundamental problem is FDA is in a severe budget crunch right now and simply lacks resources to regulate brand new technology like this," Michael Taylor, a former deputy commissioner for policy at the FDA and now a professor at the University of Maryland School of Medicine, told United Press International.

In addition, "there are some gaps in FDA's legal authority," added Taylor, who is the author of a report commissioned by the Woodrow Wilson Center's Project on Emerging Nanotechnologies that was released Thursday.

The report comes just days before the FDA's nanotechnology task force is scheduled to hold its first public meeting Oct. 10 on regulating nanotech products.

Taylor noted that the FDA's budget would have to be increased by 50 percent to bring it up to its 1996 level. And the agency's budget for next year won't improve without action by Congress. President Bush's 2007 proposed budget will increase the gap between responsibilities and capacity to 56 percent.

The budget shortfall could jeopardize nanotech products, including drugs and medical devices, Taylor said.

"FDA's lack of knowledge about nano products could result in innovative products being blocked from the market," he said.

"We need a serious rethinking of FDA's budget," he added, noting that both the drug and device industry have a vested interest in the agency having the necessary resources to review products based on nanomaterials.

The report states the legal gaps include "FDA's inability to acquire information about nanotechnology products early enough in their development to prepare properly for their regulation and ... inadequate authority for postmarket adverse event reporting."

The report recommends that to adequately regulate nanotech products, FDA needs more authority from Congress, including gaining access to safety data and post-marketing surveillance, and more funding to support hiring expert staff and develop proper toxicity testing protocols.

"The agency doesn't have people trained specifically in nanotech," Taylor said. "They need to build up staff of people who know as much about nanotech as the companies developing the products."

Dave Rejeski, director of the Project on Emerging Nanotechnologies, told UPI the report comes at an important time when industry is just starting to capitalize on nanoproducts.

"Nano is on FDA's doorstep," Rejeski said.

He noted there are 320 products with nanomaterials already on the market, including cosmetics, dietary supplements, drugs and medical devices, with 200 drugs and medical devices incorporating nanotechnology in the pipeline.

In addition, "the market size for drug delivery using nanotechnology is almost $1 billion and is expected to grow about 50 percent over the next 5 years," he said.

"There are enormous amounts of investment at stake," Rejeski said.

The U.S. government has invested $1.3 billion in nanotech research and the private sector has pumped $1.7 billion into the field, he said.

"So it's up to Congress to figure out if it's worth freeing up a few million dollars to make sure FDA has the resources to deal with this," he said.

Unfortunately, the FDA is "stretched extremely thin," Rejeski said. "Having the right authorities is not enough; you have to be able to back them up with political will and resources."

This includes having enough funding to be able to compete with the private sector for people with expertise in nanotech, he said.

A prepared FDA that could adequately regulate and prevent potential safety problems with nano products would be in the best interest of all industries that have a stake in this field.

"There's no record of anybody being harmed (by a nanoproduct) yet, but you don't want to have that happen," Rejeski said.

He noted that focus groups his organization has conducted indicate that 60 percent to 70 percent of the public are not familiar with nanotech. This means if there is a problem, they will likely associate it with all nanoproducts.

"So there could be a large spillover effect if there's a problem in one area," he said.

The FDA, the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization did not respond to UPI's requests for comment.

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