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July 18, 2012

FDA Bill Signed by President Includes Nanotechnology Provision

Lynn L. Bergeson

On July 9, 2012, President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (P.L. 112-144). The Act authorizes the U.S. Food and Drug Administration (FDA) to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs, and biosimilar biologics. It also includes a section concerning nanotechnology, directing the Secretary of Health and Human Services to “intensify and expand activities related to enhancing scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under the Federal Food, Drug, and Cosmetic Act” or other statutes administered by FDA. The Secretary may:

  1. Assess scientific literature and data on general nanomaterials interactions with biological systems and on specific nanomaterials of concern to FDA;
  2. In cooperation with other federal agencies, develop and organize information using databases and models that will facilitate the identification of generalized principles and characteristics regarding the behavior of classes of nanomaterials with biological systems;
  3. Promote FDA programs and participate in collaborative efforts to further the understanding of the science of novel properties of nanomaterials that might contribute to toxicity;
  4. Promote and participate in collaborative efforts to further the understanding of measurement and detection methods for nanomaterials;
  5. Collect, synthesize, interpret, and disseminate scientific information and data related to the interactions of nanomaterials with biological systems;
  6. Build scientific expertise on nanomaterials within FDA, including field and laboratory expertise, for monitoring the production and presence of nanomaterials in domestic and imported products regulated under the Act;
  7. Ensure ongoing training, as well as dissemination of new information within the FDA centers, and more broadly across FDA, to ensure timely, informed consideration of the most current science pertaining to nanomaterials;
  8. Encourage FDA to participate in international and national consensus standards activities pertaining to nanomaterials; and
  9. Carry out other activities that the Secretary determines are necessary and consistent with the purposes described above.