FDA Issues New Draft Guidance Documents On Access To Investigational Drugs

On May 9, 2013, the Food and Drug Administration (“FDA”) announced the availability of two new draft guidance documents answering common questions on FDA’s implementation of regulations related to access to investigational drugs. The first draft guidance, entitled “Charging for Investigational Drugs Under an IND – Qs & As,” addresses FDA’s implementation of 21 C.F.R. § 312.8 and answers the most frequently-asked questions about charging for investigational new drugs under an investigational new drug (IND) Application (IND). The regulation, which went into effect in October 2009, clarifies the circumstances under which charging for an investigational new drug in a clinical trial is appropriate. It also sets forth criteria for charging for an investigations drug and clarifies what costs can be recovered for an investigational drug.