BB&T Washington Editor

Nanotechnology and nano-matter are drawing increasing scrutiny in both the public and private sectors, as attendance at the Oct. 10 FDA nanotechnology forum demonstrated.

Nanoparticles have been present, for example, in sunscreen for decades, but as engineers create increasingly smaller nano-things, concerns about possible toxicities are sure to increase.

The recent FDA public forum on nanotechnology brought a number of voices, some calling for new regulatory requirements, others arguing that current regulations are adequate to ensure the safety of drugs, devices and biologics that contain nanomatter in one form or another.

Among those arguing that the agency’s regulatory toolbag is not up to the job were John Balbus, MD, senior scientist at Environmental Defense (New York), and Piotr Grodzinski, PhD, the director of nanotechnology cancer programs at the Alliance for Nanotechnology in Cancer at the National Cancer Institute.

Taking the opposite view, that the FDA has all it needs to safeguard public health, were Matthew Jaffe of the U.S. Council for International Business (New York) and Neil Desai, PhD, vice president of research and development at Abraxis Bioscience (Schaumberg, Illinois).

Recent advances in medical research are promising for patients, but that promise includes challenges to the knowledge base of FDA reviewers and field investigators.

For instance, scientists at the Dallas campus of the University of Texas reported in March that they had fashioned artificial muscles made of carbon nanotubes that are powered by chemical reactions using alcohol and hydrogen. Such a device could be used to power artificial limbs or even an artificial heart, but carbon nanotubes are known to be cytotoxic.

Researchers at the University of California at Berkeley and the Howard Hughes Medical Institute (Chevy Chase, Maryland) reported in July that they have come up with a work-around for this problem with a synthetic polymer that mimics a substance known as mucin, which serves as a lubricant on cell surfaces. However, the duration of the polymer’s effect has to match the intended life of a nano-device in order to maintain safety.

This is a preliminary effort and its exact ramifications, and those of similar efforts, are not yet known.

Miriam Provost, the deputy director at the Office of Device Evaluation at the agency’s Center for Devices and Radiological Health, told Biomedical Business & Technology that CDRH is no newcomer to the issues that nanotechnology presents.

“We have some internal working groups and have been looking at the science for some time,” she noted. “We think that our current regulatory processes will be adequate to address nanotechnology” in medical devices.

However, CDRH is not poised to take a blanket approach to nanomaterial-bearing devices, whether they come to the agency via the 510(k) process for devices that are based on existing approved devices or premarket approval applications for new devices.

“We will consider each application on a case-by-case basis,” she said.

Provost added: “We can’t say categorically that nanotechnology will [automatically require] a PMA. It depends on the use and the interaction with the patient.”

The FDAer commented that contact between nanomatter and the human body is a concern for CDRH reviewers, and that while biocompatibility is a point of concern, “it’s hard to make any general statements” as to how reviewers will treat an application.

Provost pointed out that the agency will have to recruit outside help to keep up with developments in the nano world, which is also the case for medical technology on the normal scale of material.

“That’s an excellent way to tap into the knowledge that we’ll need,” she said. “The medical device fellowship program is one example.”

On the other hand, the FDA is said to be staffing up of late. “We’re doing a lot of hiring and have brought on board a lot of people” who have expertise in this area, Provost said.

At present, however, the agency is not swimming in a sea of applications requiring that expertise.

“We haven’t seen a lot of applications across the board specifically incorporating nanotechnology,” Provost said. However, she advised firms looking to push a product through the regulatory mill to contact the agency.

“I would like anyone who’s developing a technology to come and talk to us early in the development process,” Provost advised.

“There may be a fear that we’re going to ask for a million and one things. We think our current process should be adequate and I’d encourage them to tell us about the technology and get our advice early in the process.”

CDRH is also keeping track of outside standards for production and characterization of nanomaterials. “We have a lot of people who work on ASTM committees,” she said, adding: “We anticipate that [standards organizations] will play a prominent role in determining whether current standards are adequate.”