BIO also wants FDA to include biopersistence as a key criterion for defining nanomaterials. Additionally, it asked the agency to exempt from the guidance inert ingredients that meet the requirements for nanotechnology, such as lubricants, binders, fillers, disintegrants, colorants, buffering agents, and coatings. It also asked the agency to clarify the scope of pharmaceutical products involving nanotech that would be subject to the guidance.
“In the pharmaceutical area, a variety of very different pharmaceutical systems or products such as micelles, polymer systems, liposomes, therapeutic monoclonal antibodies, emulsions, suspensions, crystalline particles, etc., contain nanoscale particles, but most are not considered to be ‘nanomaterials,’” noted Andrew J. Emmett, BIO’s managing director, science, and regulatory affairs.
GlaxoSmithKline (GSK) said FDA should urge nanotech companies to address the possibility of nanomaterials, especially insoluble nanoparticles, being absorbed across the GI tract. This could occur both in solution following solubilization from a nanoparticle construct or via intestinal phagocytosis, which would lead to further distribution throughout the body than for conventional micro-sized material.
“An indication that applicants should demonstrate a knowledge of the absorption mechanisms that the nanomaterial will be subjected to within the body and the breakdown or otherwise of the material once within the body, would in our opinion add to the guidance document,” wrote Bekki Komas, GSK’s director for CMC advocacy and global pre-approval, CMC global regulatory affairs.
Consumers Union (CU) said that FDA’s guidance should be mandatory for all manufacturers of nanomaterials. CU cited EPA’s voluntary Nanoscale Materials Stewardship Program, which began in 2008. A year later EPA told Congress 29 companies submitted info to EPA under the basic program and four stated they were willing to consider doing testing under the in-depth program.
“FDA should learn from EPA’s experience that the only way to ensure that the needed information is obtained is to require manufacturers to report to FDA any of their materials that meet the criteria laid out in the two questions and require safety assessments for such products,” advised CU’s senior scientist Michael Hansen, Ph.D., and program leader Carolyn Cairns.