Risk evaluation and mitigation strategies for drugs with abuse liability: public interest, special interest, conflicts of interest, and the industry perspective.
Risk evaluation and mitigation strategies (REMS) formerly known as Risk Minimization Action Plans (RiskMAPs) are a regulatory technique for dealing with anticipated risks of new medications and are especially important for new drugs with abuse potential. This paper describes the origin and history of risk-management plans for drugs that might be abused, the proper use of these plans in minimizing the risk to the public, and the special difficulties inherent in managing risks for drugs with abuse potential. Drugs with abuse liability are distinctive since the risks inherent in manufacture and distribution include not only risks to patients prescribed the medications, but also risks to the general public including subgroups in the population not intended to get the drug and who receive no medical benefit from the medication. The crafting of risk-management plans intended to protect nonpatient populations is unique for these products. The content, extent, and level of intensity of these plans affect areas of medical ethics, civil liability, and criminal prosecution. The need for risk-management plans for drugs with abuse liability can potentially act as a deterrent to investment and is a factor in decisions concerning the development of new medications for the treatments of pain, ADHD, anxiety disorders, and addictions. This paper provides a framework for moving the process of REMS development forward and criteria for evaluating the probity and adequacy of such programs.
Wright
Curtis
C
Rock Creek Pharmaceuticals, Gloucester, MA, USA. cwright@starscientific.com
Schnoll
Sidney
S
Bernstein
David
D
D016907:Adverse Drug Reaction Reporting Systems; D002701:Chloramphenicol / Q000009:adverse effects; D017327:Clinical Trials, Phase IV as Topic; D016265:Conflict of Interest; D017277:Drug Approval / Q000331:legislation & jurisprudence; D015195:Drug Design; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D004345:Drug Industry / Q000941:ethics / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000639:trends; D005544:Forecasting; D006801:Humans; D013287:Illicit Drugs; D010098:Oxycodone / Q000009:adverse effects; D010353:Patient Education as Topic; D010606:Pharmacy and Therapeutics Committee; D011634:Public Health; D018570:Risk Assessment / Q000379:methods* / Q000458:organization & administration; D012308:Risk Management / Q000379:methods* / Q000458:organization & administration; D019966:Substance-Related Disorders / Q000517:prevention & control*; D014481:United States; D014486:United States Food and Drug Administration
D013287:Illicit Drugs; D002701:Chloramphenicol; D010098:Oxycodone