Drug Safety Oversight Board Meeting, May 17, 2012

Public Summary

The following is a Drug Safety Communications (DSC) posted since the March 15, 2012 meeting and relayed to the Drug Safety Oversight Board (DSB or Board) via memorandum:

• May 14, 2012 FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod). This update is in follow-up to the FDA Drug Safety Communication: Safety review of a reported death after the first dose of multiple sclerosis drug Gilenya (fingolimod) on 12/20/2011.

The DSB discussed two topics:

1. FDA-Approved Labeling and Public Payer Coverage Decisions
2. Opioid Patient Prescriber Agreements: Design, Piloting and Implementation

FDA-Approved Labeling and Public Payer Coverage Decisions
James P. Smith, MD, MS, Division of Metabolism and Endocrinology Products (DMEP)

The Board heard a presentation from Dr. James Smith from the Division of Metabolism and Endocrinology Products (DMEP) regarding FDA-approved labeling and public payer coverage decisions. The Board discussed varying scenarios in which a drug could be a “covered drug” in the programs of federal partners based on clinical trial data that suggests a patient benefit that is not reflected in the approved indication labeling, and the impacts of these scenarios on federal partner clinical and pharmacy programs.

Opioid Patient-Prescriber Agreements: Design, Piloting and Implementation
Mary Ghods, RPh, Safe Use Initiative, CDER

Insights from Shared Decision Making to Improve Prescriber-Patient Agreements (PPAs) for Opioid Drugs
Nananda Col, MD, MPP, MPH
University of New England, Portland, ME

The Board heard two related presentations bearing on opioid prescriber-patient agreements, from Mary Ghods, RPh, of the CDER Safe Use Initiative, and Nananda Col, MD, MPP, MPH.

The Board discussed time demands for implementing a PPA in acute care settings; clarification of PPA intent, and the need for plain language editing.