Expert Challenges FDA to Bring Predictability, Feasibility, and to Drugs 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
CONTACT: Michelle Ertischek, +1-301-718-8440 ext. 209,
mertischek@pinneyassociates.com
Posted: July 2010
