1 FDA Guidance for Industry Development and Use of Risk Minimization Action Plans Anne Trontell, M.D., M.P.H. Deputy Director CDER Office of Drug Safety Pharma Audioconference April 11, 2005

2 Guidance Published March 24, 2005 at –/5766dft.pdf RiskMAPs –/5765dft.pdf Premarketing –/5767dft.pdf Pharmacovigilance

3 Risk Management Risk Assessment + Risk Minimization

4 Risk Assessment and Risk Minimization Highly inter-related Occur both pre- and post-marketingOccur both pre- and post-marketing Best if both are evidence-basedBest if both are evidence-based Risk minimization efforts are based upon good risk assessment

5 Key Points about Guidance Two rounds of commentary valuableTwo rounds of commentary valuable –Concept paper and draft guidance Framework, nomenclature will aid FDA and Industry discussionsFramework, nomenclature will aid FDA and Industry discussions –Common terminology –Recommendations for when, how, what of discussions and submissions

6 Key Points about RiskMAPs Start with good risk and benefit assessmentsStart with good risk and benefit assessments Seek stakeholder input, transparencySeek stakeholder input, transparency Set clear goals for health outcomesSet clear goals for health outcomes Define intermediate objectivesDefine intermediate objectives Pick tools from 3 categoriesPick tools from 3 categories –Targeted education and outreach –Reminder systems –Performance-Linked Access Systems Evaluate and communicate with FDA about progress, possible changesEvaluate and communicate with FDA about progress, possible changes

7 Final vs. Draft Guidance Evaluation strengthened and clarifiedEvaluation strengthened and clarified Decision-making and consistency questions addressedDecision-making and consistency questions addressed –Public advisory committees –CDER clearance of RiskMAPs with reminder or restricted distribution tools

8 For Reference

9 Risk Minimization Action Plan (RiskMAP) Definition A strategic safety program designed to meet specific goals and objectives in minimizing known risks of a product while preserving its benefits Uses one or more tools to accomplish these ends

10 RiskMAP Definitions Goal – End result, expressed in terms of one or more health outcomes to be achieved (or avoided)Goal – End result, expressed in terms of one or more health outcomes to be achieved (or avoided) Objective – Intermediate step to achieving the goal(s)Objective – Intermediate step to achieving the goal(s) Tool – System or process other than product labelingTool – System or process other than product labeling

11 Definitions Applied to a Fictional Example Goal: A dangerous drug-drug interaction should not occurGoal: A dangerous drug-drug interaction should not occur Possible Objectives:Possible Objectives: –Physicians won’t co-prescribe 2 drugs –Pharmacists won’t co-dispense –Patients won’t take 1 drug with the other Tools: Education, pharmacy alert screens, or restrictions on physicians or othersTools: Education, pharmacy alert screens, or restrictions on physicians or others

12 Categories of RiskMAP Tools Targeted Education & Outreach Targeted Education & Outreach –to inform Reminder Systems Reminder Systems –to alert or reinforce Performance-Linked Access Systems Performance-Linked Access Systems –to block unsafe use

13 Summary: RiskMAPs Apply to a small number of productsApply to a small number of products Have clear goals and objectivesHave clear goals and objectives Use tools thatUse tools that –are evidence-based –allow appropriate product access –consider stakeholder input, technology, use settings, other factors Are evaluable and monitoredAre evaluable and monitored