CPDD Sponsors Workshop on Risk Management
On October 27-28, the College on Problems of Drug Dependence held a conference on Risk Management and Post marketing Surveillance of CNS Drugs. The conference was co-sponsored by APA, among a few other scientific organizations, and coordinated by several CPDD/APA Fellows, including Dr. Jack Henningfield, Dr. Bob Balster and Dr. Bob Schuster. Blending expertise from academia, government and pharmaceutical industry representatives, the conference was designed as another in a series of such workshops held in 2002, 2005 and 2006 addressing abuse liability assessment and the issues and opportunities posed by developments in drug formulations.
Drs. Henningfield and Balster outlined the background/rationale for the conference in their letter of invitation:
"Risk management programs, including post-marketing surveillance, have been increasingly encouraged by FDA across a broad range of drugs over approximately the past decade, with final guidance documents issued in March of 2005. FDA has been working with drug sponsors and other agencies to develop and evaluate risk management approaches and this has additional implications for research sponsored and or conducted by NIH and SAMHSA to strengthen the science base. The process has now become even more complicated with the March 2008 implementation of the 2007 FDA Amendments Act (FDAAA) provisions requiring Risk Evaluation and Mitigation Strategies (REMS) for certain drugs, and with Controlled Substances receiving particular attention. From a drug development perspective, this then adds a new layer of complexity to the scientific evaluation of CNS drug that will be considered for Controlled Substance Scheduling and/or REMS.
The science base for decision making by drug developers as well as regulators is thus vital to ensure orderly and appropriate development and implementation of risk management (including REMS) and post marketing surveillance. Fortunately, many of the scientific challenges are of the sort that CPDD-affiliated scientists have addressed for decades through research, and the annual and special meetings. The College provides a natural forum to explore the issues and develop credible recommendations for drug developers, regulators and researchers. Challenges including prediction of potential real world risks of abuse and diversion as well characterization of potential risks related to the pharmacology of the drugs (e.g., behavioral disruption at the personal and social levels)."
One goal of the conference will be to develop an expert report like that published as a supplement following the 2002 conference (Expert Panel, Abuse liability assessment of CNS drugs: Conclusions, recommendations, and research priorities. Drug and Alcohol Dependence, 70 (Supl.): S I 07-S I I 4, 2003 ).