FDA Week is reporting that a meeting at the Food and Drug Administration late last month failed to result in any agreement about a possible policy on nanomaterials. The FDA Nanotechnology task force met on July 22, 2008 to consider the creation of a policy for nanomaterials, but failed to come to any consensus on whether one should be drafted, let alone the contents.
The primary disagreement appears to be whether to issue a policy at all, or rely on existing statutory and regulatory controls. As one might expect, the panel was split on this issue, resulting in no action in the short term. The split was right down the middle with 5 panel members voting in favor of a policy, 5 voting against, and 1 abstaining.
The panel did agree that FDA should collaborate with OSHA and EPA should either agency begin drafting a policy concerning nanoparticles. FDA will hold a public meeting in September to discuss particle size in drugs and how to obtain such information from its current database.
FDA’s inaction is not wholly surprising given the state of nanotechnology regulation. However, the even split was somewhat unexpected. The debate seems to center around the data submissions by companies seek FDA approval on products and what is already required. I, personally, would not have thought the division would be so even (unless purposefully manufactured). Perhaps this is a mircochasm of the public generally, that being a 50/50 split on what the next step should be? Or perhaps this is administrative gridlock in an election year? Or perhaps this is simply an administrative agency continuing to act deliberately in considering the nanotechnology question?
