Expert Challenges FDA to Bring Predictability, Feasibility, and Transparency to Drug Risk Management Process

BETHESDA, Md., July 22 /PRNewswire/ -- 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.

Dr. Schnoll is an internationally recognized expert in addiction and pain management who applies his experience of over 30 years in academic medicine to the issues of risk management. Dr. Schnoll was a member of the team that developed the program enabling Ultram (tramadol) being launched as an unscheduled analgesic, and the principal investigator on the post-marketing health care professional surveillance project to monitor for abuse and diversion.  In 2001, Sid joined Purdue Pharma L.P. where he developed the RADARS® System to study the abuse and diversion of prescription opioids.

In addition to his work at PinneyAssociates, Dr. Schnoll is Clinical Professor of Internal Medicine and Psychiatry at the Medical College of Virginia, Virginia Commonwealth University and Voluntary Professor of Behavioral Science at the University of Kentucky.

Dr. Schnoll has served on numerous committees and boards including the FDA's Drug Abuse Advisory Committee (DAAC), NIH study sections, National Board of Medical Examiners test development committees, and was a board member of the College on Problems of Drug Dependence (CPDD).  He has received numerous awards including listings in The Best Doctors in America and is a Fellow of CPDD and the American Society of Addiction Medicine.

PinneyAssociates' teams of scientists, public health professionals, and health policy experts help companies get new drugs approved, obtain the appropriate controlled substance scheduling from the Drug Enforcement Administration, and secure switches from prescription to over the counter status.  We do this by advising on abuse liability assessments for central nervous system acting drugs, developing required documents for New Drug Application submissions and risk management, and preparing companies for meetings with the Food and Drug Administration and its Advisory Committees.

SOURCE PinneyAssociates

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