The pharma company issued its plea in a response to the FDA’s (Food and Drug Administration) draft guidance titled ‘Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology’.
Replies from many companies said the board’s definition of nanoparticles was too broad, and would lead to extra layers of un-needed regulation on products just because they fall within the FDA’s new nano brackets.
GSK went one step further calling for the regulator to address the biological fate of nanomaterials, and that it should put more emphasis on approval applicants’ knowledge of how a nanoparticle is broken down in vivo. The company put particular focus on breakdown within the gut.
In the letter, GSK director of CMC advocacy Bekki Komas, wrote: “One area the guidance document could be strengthened is by addressing the biological fate of nanomaterials, especially of insoluble nanoparticles, following oral administration.
“It is possible that active materials will be absorbed across the GI tract both in solution following solubilisation from a nanoparticle construct, or additionally, intact via intestinal phagocytosis which would leading to further distribution throughout the body than for conventional micro sized material.”
In response to a sentence in the draft guidance which stated that routes of exposure, dosage and behaviour in various biological systems would still be critical for evaluating products, Komas added: “The applicant 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.”