Analysis: FDA comes up short on nanotech

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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

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

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

"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


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