Reporting Format for Nanotechnology Related Information in CMC Review
Recently, the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Science issued the above entitled addition to CDER's Manual of Policies and Procedures(MAPP). This produced some uproar in the nanotech community by some who interpreted a single line as indicating that the FDA was about to start redefining nanomaterials.
The purpose of this new MAPP is to provide "chemistry, manufacturing, and controls (CMC) reviewers within the Office of Pharmaceutical Sciences (OPS) with the framework by which relevant information about nanomaterial- containing drugs will now be captured in CMC reviews of current and future CDER drug application submissions. This information will be used to develop policy regarding these products."
In its background section, the MAPP notes that "because development of nanotechnology based drugs is still in its infancy, there are no established standards for the study or regulatory evaluation of these products." (Emphasis added). The MAPP then goes on to define nanomaterials/nanoscale materials as "any materials with at least one dimension smaller than 1,000 nm".
What is important to note here is the language contained in a footnote: "The definations described in this section apply only to this MAPP". (Emphasis added). This defination, in short, doesnot apply outside of the manual. While the accepted defination of nanomaterials is that of any material at smaller than 100 nm, there is currently no legal defining of nanomaterials. Title I Section 102 of H.R. 5116, The America COMPETES Reauthorization Act of 2010 would define "nanoscale" as meaning "one or more dimensions of between approximately 1 and 100 nanometers". HR 5116, discussed here earlier, has passed the House and awaits action in the Senate.
The remainder of the MAPP consists of informing OPS CMC reviewers of their responsibility for "correctly documenting nanotechnology related information in their reviews" and for presenting this information, which will cover such items as what nanomaterials are present in the drug, does the nanomaterial dissolve in water, etc, in tabular form, which will be used later to populate the aforementioned database.
As as been noted here and in a variety of medical and science journals, nanotechnology's most immediate impact may be in the medical field, particularly in the treatment of cancer. The use of nanomaterials in medications and therapy is the latest development in the medical world and is fraught with controversy. By creating the database described in this MAPP, the FDA would be taking a first step towards fulfilling it's regulatory duty to the American public, by gathering information on which it can base later decisions and policies.
