Pharma Companies Want Changes to FDA’s Enteral Tube Drug Delivery Guidance

Several drugmakers have offered suggestions in written comments to the FDA for revisions to the agency’s draft guidance on in vitro testing and labeling of oral drugs intended to be given by enteral tube.

In the draft guidance, which the FDA released June 2, the agency noted that in vitro testing prior to clinical studies can help identify product-specific risks.

In its comment on the draft, Eli Lilly, for example, said that the whole guidance would benefit from being “written following a risk-based approach with examples,” while Merck asked the FDA to confirm in the final guidance that “a case-by-case risk-based assessment is appropriate.”

And Boehringer Ingelheim asked why the guidance does not include the administration of oral solutions, given that “except for dispersion media/preparation and dissolution testing, very similar experiments would be conducted.”