Drugs

Comments on Drug Administration Vehicles

AstraZeneca says an FDA draft guidance on use of liquids and/or soft foods as vehicles for drug administration “provides a useful framework for the selection and assessment of vehicles for alternative dosing” and is based on good scientific practice. The company cautions that although the guidance is applicable to different stages of development, no provision is made for the level of assessment that may be reasonably expected at each of the different stages.

Lilly recommends that the full requirements of the guidance be limited to NDAs and BLAs, as applicable, and supplements to those applications. It also says that a section of the guidance on palatability and swallowability contains valuable information for considering the risks associated with palatability, swallowability, and the relationship to patient acceptance. However, it continues, much of this information is more relevant and actionable in the design of age- or disease-state appropriate formulations, and is much less actionable in the context of using food or liquids as alternative administration vehicles.

Pfizer says it welcomes the focus and intention of the guidance, but says there are parts that are overly detailed and prescriptive. “It would be useful if the guidance was provided at the ‘what needs to be achieved’ level and not at the ‘this is how this should be done’ level,” it says. It also says it would be most useful if guidances such as this one are well aligned to regulatory expectations in other regions such as the European Union.

In its comment, Genentech recommends that phase-appropriate expectations for clinical development be included in the document. And, it says, it is important that the safety of the person performing the admixture with liquids or soft foods be addressed.

All four companies provided detailed line-by-line comments in addition to their general comments. Specific comments also were submitted by Merck and Gilead.

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