USA – FDA allows sponsors to spread out costs in revised IND charging guidance

The US Food and Drug Administration (FDA) on Monday issued draft guidance providing advice to sponsors about when and how they can charge for an investigational new drug in a clinical trial or under expanded access. If finalized, the guidance would supersede a 2016 final guidance on the topic; it also addresses new stakeholder questions that have been asked of the agency since the final guidance was issued.

FDA first issued draft guidance on charging for investigational new drugs under an investigational new drug application (IND) in 2013 in response to stakeholder questions about a 2009 final rule that revised FDA’s regulations on when patients can be charged for an investigational treatment. FDA says it received additional questions from stakeholders since that guidance was finalized in 2016, and the newly issued draft guidance addresses those questions through several clarifications and three newly added questions related to cost recovery calculations…