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Should FDA Regulate Nanomedicine Differently?



June 20th, 2008

Editor’s Note: In an interview published this week, Health Affairs Contributing Editor Barbara Culliton asks Food and Drug Administration (FDA) Associate Commissioner For Science, Norris Alderson, about his agency’s regulation of nanomedicine and the potential for health care cost savings. Here’s an excerpt of their conversation:

Barbara Culliton: Nanomedicine is the “next big thing” in medicine, following fast on the heels of developments in genomics and the other “-omic” sciences…. Are drugs or devices with nanoparticles evaluated under the same regulatory framework as other products [by the FDA]?

Norris Alderson: Very good question, and one our current commissioner asked us. Back in 2006, Commissioner [Andrew] von Eschenbach asked senior staff members to assess our readiness to deal with nano-engineered materials in the products we regulate. So you’re scanning all the way from drugs, biologics, devices, food, food additives, nutritional supplements, cosmetics–the whole gamut has the potential for nano-engineered material to be incorporated into it. The commissioner wanted to be certain there is a predictable pathway for evaluating these products before they get to the marketplace and are used by the American consumer. So, he appointed a task force, which I cochaired.

We reached a number of conclusions. Perhaps the most important is that, for now, this technology is really no different than any other new technology that would be incorporated into FDA products. So with that in mind, we feel comfortable, if you will, using our present regulatory framework. However, we felt there is need for guidance to help this industry as it moves forward. We recognized a need for additional information in various areas, such as biosafety. FDA and other agencies are working together on that. But for now, we just do not see the need for regulations written specifically for nano-engineered materials in the products FDA regulates.

Culliton: What about the fact that nanoparticles are fundamentally different from larger-scale molecules? Some researchers worry that there may be hazards as well as benefits.

Alderson: That was an important consideration for the task force. While on the one hand saying that we do not see the need for a new regulation, we also recognize that because of these nanoparticles’ unique biological and physical properties, there is a lot we do not and cannot yet know. So until we know more or have better information about this, we are going to continue to use the same approach as we’ve used for other products to assess safety and efficacy. If science later tells us something different, we will respond. We’re ready. We’re paying close attention to this. For instance, if you nanosize a drug, you’re probably making that drug more available in terms of its biological interaction. So you might have to use less of it. That is something we would want to know.

Culliton: Given the specificity and potential range of nanomedicine, do you anticipate appreciable effects on the cost of medical care using these products?

Alderson: I think we’re all hopeful that nano materials will reduce costs of health care because of the products that it will bring that we have not seen before. But I think it’s just too early to really tell. Until we see some of these products make it to the marketplace, it’s all conjecture.

The full interview with Alderson is free access online until July 1.

A second interview with researchers Lance Liotta and Emanual Petricoin on nanomedicine and the power of proteins is also new online.

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