Expert to speak on challenges, issues in development, implementation of REMS

At two Food and Drug Administration meetings, Sidney H. Schnoll, MD, PhD, Vice President, Pharmaceutical Risk Management Services of PinneyAssociates, will discuss the need for predictability, feasibility and transparency to ensure that Risk Evaluation and Mitigation Strategies (REMS) benefit patient safety and public health.

"A standardized process that is defined by predictability and feasibility, and supported by increased transparency, is urgently needed," said Dr. Schnoll. "It is essential that FDA continue to seek out the views of prescribers, patients, the drug abuse prevention and treatment community, and the pharmaceutical industry.  That outreach is critical to successfully managing the risks associated with opioids.  It's a balancing act, preventing unintended consequences such as overdose while ensuring access to important medications for people in pain."

Dr. Schnoll is speaking on July 23, 2010, at the joint meeting of the FDA's Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.  These committees are meeting to advise the Agency on a proposed plan to reduce inappropriate prescribing and misuse of extended-release and long-acting opioid analgesics.  He will also address the FDA on July 28, 2010, at the Risk Evaluation and Mitigation Strategy public meeting regarding challenges and issues in the development and implementation of REMS.