On May 9, 2013, the Food and Drug Administration (“FDA”) announced the availability of two new draft guidance documents answering common questions on FDA’s implementation of regulations related to access to investigational drugs. The first draft guidance, entitled “Charging for Investigational Drugs Under an IND – Qs & As,” addresses FDA’s implementation of 21 C.F.R. § 312.8 and answers the most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.
The second draft guidance, entitled “Expanded Access to Investigational Drugs for Treatment Use – Qs & As,” answers the most frequently-asked questions related to FDA’s implementation of its expanded access regulations (21 CFR Part 312, Subpart I). The regulations, which went into effect on October 2009, contain the requirements for the use of investigational new drugs or approved drugs where availability is limited by a risk evaluation and mitigation strategy, when the primary purpose is to diagnose, monitor, or treat a patient’s disease or condition.
Comments on the draft guidance documents should be submitted in writing, or electronically at www.regulations.gov, on or before July 8, 2013.