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Princeton, June 2004 © Risk Management Resources 1 The Risk Management Initiatives and Drug Development Felix M Arellano, MD, Dip Pharm Med, FISPE
2Princeton, June 2004© Risk Management Resources Definitions. Pharmacovigilance Plan (PVP) All products launched with PVP Data from pre-clinical development Data from pre-clinical development Data from clinical development Data from clinical development Class or “family” safety “issues” Class or “family” safety “issues” Data from population intended to receive the agent Data from population intended to receive the agent Steps needed to gain further knowledge Steps needed to gain further knowledge PVP (ICH) = PV Specification + Action Plan
3Princeton, June 2004© Risk Management Resources Risk Minimization Action Plan (formerly Risk Management Plan) RMP. Similar to PVP + Risk assessment/measurement Risk assessment/measurement Risk confrontation Risk confrontation Risk intervention (minimization or tools) Risk intervention (minimization or tools) Risk management evaluation Risk management evaluation Risk communication Risk communication RM (FDA) = Risk assessment + risk minimization
4Princeton, June 2004© Risk Management Resources Risk Management
5Princeton, June 2004© Risk Management Resources Where we are FDA PDUFA III. Pre NDA meeting packages should include safety information and proposal for Risk Management Plans (RMP) Pre NDA meeting packages should include safety information and proposal for Risk Management Plans (RMP) NDA Review. RMP must be submitted no later than one month prior to official action date NDA Review. RMP must be submitted no later than one month prior to official action date Guidance Papers. 2 nd draft released on May 5 th and is open for comments Guidance Papers. 2 nd draft released on May 5 th and is open for comments Implementation expected in 2004
6Princeton, June 2004© Risk Management Resources Where we are (cont.) EMEA. EU Heads of Agencies developed a “EU Risk Management Strategy” in January 2003 Guidance on Risk Management can be obtained during “scientific advice” Guidance on Risk Management can be obtained during “scientific advice” By the time of approval all products are expected to have a RMP or a statement that no specific “safety measure” is needed By the time of approval all products are expected to have a RMP or a statement that no specific “safety measure” is needed
7Princeton, June 2004© Risk Management Resources Where we are (cont.) ICH Guideline (E2E) has been adopted by FDA FDA will issue its guidelines in 2004
8Princeton, June 2004© Risk Management Resources Where we are (cont.) RM concept has shifted RMP were originally designed to manage KNOWN risks (terfenadine, mebefranil, astemizole, bromfenac)
9Princeton, June 2004© Risk Management Resources Where we are (cont.) RM concept now involves pre-marketing risk assessment during which, by definition, post-marketing risks are not known
10Princeton, June 2004© Risk Management Resources Why is RM here? Perception vs. Reality General perception of an “increased regulatory pressure”: There are less regulatory approvals There are less regulatory approvals More drugs are withdrawn More drugs are withdrawn Agencies are more cautious in granting approvals Agencies are more cautious in granting approvals
11Princeton, June 2004© Risk Management Resources Average Number of Drugs Approved per Year. FDA DecadeNo. Drugs 1940s3 1950s s s s s41
12Princeton, June 2004© Risk Management Resources Last 5 years of the 20 th Century (FDA) Almost a drug per week!!!
13Princeton, June 2004© Risk Management Resources Number of NME/NDA Approved per Calendar Year NDA Standard NME Expedited NME
14Princeton, June 2004© Risk Management Resources Number of NMEs Withdrawn as a Percentage of NME Approved Number Proportion
15Princeton, June 2004© Risk Management Resources Proportion of Standard NDA Approved
16Princeton, June 2004© Risk Management Resources Proportion of Standard NDA Approved
17Princeton, June 2004© Risk Management Resources Number of Drug Safety Alerts ( ) clinical alert of SAEs, black box warnings, voluntary recalls, counterfeits and market withdrawals CAGR 18%
18Princeton, June 2004© Risk Management Resources Number of Safety – Related Label Changes ( ) CAGR 21% Flat after 1997 – 1998 Skepticism over effectiveness of label changes as RM tool
19Princeton, June 2004© Risk Management Resources Why is RM here? Perception vs. Reality General Perception of an increased regulatory pressure: There are less regulatory approvals +/- There are less regulatory approvals +/- More drugs are withdrawn + More drugs are withdrawn + Agencies are more cautious in granting approvals + Agencies are more cautious in granting approvals + Overall increase in regulatory pressure over label changes ++ Overall increase in regulatory pressure over label changes ++
20Princeton, June 2004© Risk Management Resources Why do companies need RM? It is the right thing to do It is here, whether you like it or not R & D reasons: R & D reasons: Leaner Pipelines Leaner Pipelines Less “unmet medical needs” Less “unmet medical needs” Narrower indications Narrower indications Higher R & D Costs Higher R & D Costs
21Princeton, June 2004© Risk Management Resources Why do companies need RM? (cont) Regulatory Reasons Agencies (and society) are becoming increasingly risk-averse Agencies (and society) are becoming increasingly risk-averse Smaller benefits; make benefit: risk analysis challenging Smaller benefits; make benefit: risk analysis challenging “Err on caution” translates in restrictions, delays, withdrawals (or all the above) = lower revenues “Err on caution” translates in restrictions, delays, withdrawals (or all the above) = lower revenues Opportunity is to translate challenge to advantage
22Princeton, June 2004© Risk Management Resources What to Expect Compliance must be a given Focus on life cycle management Peri-launch and post-marketing periods are simply part of a continuum Peri-launch and post-marketing periods are simply part of a continuum Sponsors cannot be expected to predict completely the safety profile… But they will be expected to follow up on the identified ones, and… But they will be expected to follow up on the identified ones, and… Actively look for new ones Actively look for new ones
23Princeton, June 2004© Risk Management Resources PVP/RMP in Development Pharmacovigilance Plans (PVP) starting in exploratory development and being followed through development
24Princeton, June 2004© Risk Management Resources Risk Communication Of all the components of the RMP this is the most complex, multidisciplinary and challenging Balance between adequate, and exaggerated Communication of risk falls on underlying perceptions of the receiver
25Princeton, June 2004© Risk Management Resources
26Princeton, June 2004© Risk Management Resources Risk Communication
27Princeton, June 2004© Risk Management Resources Issues Monumental task impossible to tackle pleasing everyone Categorization of drugs was removed from new version Risk minimization, not avoidance. Risk reduction better Endorses RM as part of life-cycle Endorsees and guides on RM in pre and post-marketing
28Princeton, June 2004© Risk Management Resources Issues. Cons Lack of precision regarding when to prepare PVP and RMAP as well as “routine PV” Confusion around whether RM will narrow exposure to drugs Older drug issue not tackled Avoiding need for PVP Contradiction with ICH E2E (endorsed by FDA) Label as risk communication tool and cornerstone Exclusion of industry from certain forums
29Princeton, June 2004© Risk Management Resources Issues Will companies take RM seriously without clear guidelines? Precedents are not reassuring Precedents are not reassuring Traditionally, pharmacovigilance is considered an expense, not an investment
30Princeton, June 2004© Risk Management Resources Issues Distribution of burden among society members Including patients, and its “informed” consent
31Princeton, June 2004© Risk Management Resources Issues (cont) Implementation of RM concept cannot be harmonized Information overload Not a panacea. E.g. toxicity in elderly due to misadministration
32Princeton, June 2004© Risk Management Resources THANK YOU
33Princeton, June 2004© Risk Management Resources 4 Oak Lane Califon, NJ 07830, USA
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