Nanotechnology Presents R&D Quandary for FDA

Newhouse News Service

October 31, 2006

The Food and Drug Administration has a small problem. It's called nanotechnology.

As companies develop drugs, medical devices, cosmetics and dietary supplements using particles as small as one-billionth of a meter, the FDA is struggling to keep up with the revolutionary science while being pushed in two opposing directions.

Policy experts and consumer advocates say the agency needs to get up to speed and toughen oversight to ensure the public health is protected. But commercial interests, concerned about regulatory delays and the stifling of medical breakthroughs, say they want the FDA to rely on existing standards and procedures to review products with nano materials.

Michael Taylor, a former FDA deputy commissioner for policy and author of a report on the FDA and nanotechnology, said the agency lacks the resources and in some cases the legal authority to properly evaluate nano-based products.

"Does the FDA have the tools it needs to oversee nanotechnology in a way that meets public expectations to be sure unsafe products are not out there and to make sure beneficial products reach market? The short answer is unavoidably `no,"' Taylor said.

Business interests said they believe the concerns are overblown, and fear added requirements would unfairly hamper commercialization of products containing nano particles. At an FDA meeting on nanotechnology earlier this month, Matthew Jaffe of the U.S. Council for International Business said the agency already has in place "a comprehensive regulatory system."

"We thus strongly encourage FDA to regulate applications that use nanotechnology according to the same guiding scientific principles that already allow this agency to effectively protect, promote and improve public health," said Jaffe, whose organization represents more than 300 multinational corporations, law firms and business associations.

There is great hope nanotechnology will be used to develop medicines to treat diseases and create delivery systems to get drugs to parts of the body that are hard to reach.

The concern is that the tiny particles whether in pills, injectibles, dietary supplements or even cosmetics and sunscreens might enter the bloodstream or tissues in ways that could be unpredictable, and potentially harmful. So far no harm has been documented, but critics are worried that testing is inadequate, that the scientific literature is still very incomplete and that the FDA's review process is outdated.

Materials engineered on the nano scale often have chemical or physical properties that are different from common materials. Nano materials can range in size from about 1 to 100 nanometers. A nanometer is a billionth of a meter, with a human hair measuring about 80,000 nanometers in width.

The National Science Foundation has predicted the ability to create novel properties on such a small scale could affect the production of almost every man-made object, and lead to useful technologies for manufacturing, medicine, energy production, the environment, computation and communications.

Technology consultant Matthew Nordan of Lux Research recently told Congress $32 billion worth of products incorporating nanotechnology were sold worldwide in 2005, and predicted manufactured goods using nanotechnology will be valued at about $3 trillion by 2014.

NanoBiotech News estimated earlier this year there were 130 nano-based drugs and delivery systems and 125 devices or diagnostic tests in preclinical, clinical or commercial development, an increase of 68 percent compared with 2005 figures.

Products under development include "smart" nanoparticles that seek out a specific location within the human body and deliver a precisely targeted drug dose; nanosensors circulating inside the body to monitor glucose, hormone and cholesterol levels; nanoparticles that kill antibiotic-resistant microbes; and gold "nanoshells" that zero in on cancer cells that, once identified, can be destroyed by a non-invasive laser.

The FDA doesn't single out products with nano particles for special review. The handful of drugs with nano materials that have been approved so far went through the normal clinical testing and review process.

Devices, too, have been subject to standard procedures. Sunscreens, cosmetics and dietary supplements, whether with or without nanomaterials, are allowed on the market without prior FDA approval.

According to the Project for Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars in Washington, D.C., there are 52 cosmetic products and 16 sunscreens on the market containing nano materials. A number of environmental and public interest groups have petitioned the FDA to recall some of these products until they are proven safe.

The Woodrow Wilson project, citing NanoBiotech News, said there are nine available nanotechnology drug and drug delivery products approved by the FDA. These include an anti-nausea drug for chemotherapy patients; a topical estrogen therapy; a drug designed to stimulate appetite; and an injected suspension used to treat advanced forms of breast cancer.

According to a report issued last month by the ETC Group, a Canadian-based organization, the major pharmaceutical companies generally have been taking a "wait and see attitude" on nanotechnology. The report said they have not invested heavily on research, but have been collaborating with small biotechnology companies, entering into licensing agreements, relying on government and academic research, and biding their time as the technology develops and the regulatory climate becomes clearer.

This past summer, the FDA created a task force that will report in May 2007 on regulatory approaches to nanotechnology and on any "policy gaps" that may exist.

Acting FDA Commissioner Andrew von Eschenbach said the task force must look at "the current state of scientific knowledge pertaining to nanotechnology" and the emerging issues regarding "biological interactions that may lead to either beneficial or adverse health effects."

"As this exciting new area of science develops, the FDA must be positioned to address both health promotion and protection challenges that it may present," von Eschenbach said.