Steve Mullenix, NCPDP’s Senior Vice President Public Policy & Industry Relations, provided testimony as a subject matter expert at a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA).
The hearing took place on November 14th at FDA offices in Silver Spring Maryland. The FDA evaluated a new drug application (NDA) submitted for an abuse deterrent formulation (ADF) of oxycodone IR. Steve was asked to provide a perspective regarding the NDA and other means of assuring safe use of opioids (i.e.NCPDP Standards-based Facilitator Model for PDMP, An Interoperable Framework for Patient Safety) and how these efforts coincide. Following testimony, the Joint Committee voted in favor of the NDA, approving it by a 10-7 vote.