The FDA’s Advisory Committee for Pharmaceutical Science and Clinical Pharmacology met last week. Among the agenda topics was a discussion of current thinking on issues pertaining to the use of nanotechnology in drug manufacturing, drug delivery, or drug products. (The general function of this committee is to provide advice and recommendations to the agency on regulatory issues.) Scheduled to speak were representatives of the Office of Pharmaceutical Science at CDER, nano-medicine industry leaders, and academics.

MassTortDefense has posted on nano-technology here.

As CDER grapples with questions regarding how to regulate nanomaterial-containing products, several issues have surfaced, including 1) what are the types of nanotechnology applications that will be reviewed by CDER, 2) what are the unique features of these applications that may pose a scientific and/or regulatory challenge to reviewers, 3) are FDA’s current regulatory requirements adequate for the evaluation of nanomaterial-containing products, and 4) what can FDA do to expedite the development of safe and effective nanomaterial-based pharmaceuticals.

Nanotechnology applications in drug development are likely to have a significant impact on the products that FDA regulates. Products containing nanomaterials are being investigated for potential applications as therapeutics, and some products containing nanoscale materials are already on the market. While some of these nanomaterials are nanoscale versions of larger materials used in approved products, other nanomaterials are novel and have never been used in drug products. CDER has initiated a number of activities in order to evaluate how this new technology fits into the current regulatory framework. There have been questions raised about the need for “nano”-specific requirements, in part to aid the development of products containing nanomaterials, and in part because nanomaterial containing products may need to fulfill different regulatory requirements prior to approval.

The FDA established a Nanotechnology Task Force, which issued a report in July 2007. In the task force report, recommendations were made regarding FDA’s future direction for regulating nanomaterial-containing products. Guidance development was included as one the recommendations. FDA believes, however, that the preclinical studies currently required of sponsors are very comprehensive, and include many studies that measure endpoints that could predict possible injury in many organ systems. While general issues have been raised, no one has clearly communicated in what respect the current requirements might be lacking in their capacity to assess safety concerns from such products, and what might be other tests that would improve the predictive value of the current regulatory preclinical requirements.

Nevertheless, because it is widely accepted that there are unique features associated with
nanotherapeutic products, these unique features may lead to future challenges for the development, manufacturing, and possibly safety evaluation and review of these products. Accordingly, the committee was set to discuss:

1. Is CDER guidance needed for the development of nanotechnology-derived drug applications?
2. If guidance is needed from CDER, what areas should this guidance focus on?
3. In light of the many definitions of nanotechnology available, how should CDER define nanotechnology, for the purposes of guidance development?
4. Should particle size information be routinely requested of drug developers, regardless of whether nanomaterials are included in the product? How might this information help in the assessment of safety and efficacy of drugs?

Clearly this is no small issue.