Developing Risk Management Systems that meet FDA rules ---and don’t hurt your product. Judith K. Jones President, The Degge Group, Ltd. Louis A. Morris President , Louis A. Morris & Associates Gina Ashe VP Marketing, Infomedics. Objectives. P.
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Judith K. Jones
President, The Degge Group, Ltd.
Louis A. Morris
President , Louis A. Morris & Associates
VP Marketing, Infomedics
Objectives ---and don’t hurt your product
articipants should appreciate strategic and tactical elements for developing a Risk Management (RM) Plan:
92 NME’s from 1998-2000
“FDA took this action after its review of recent safety data…showed that Rezulin is more toxic to the liver than the other two drugs” [HHS News, 3/21/00]
“And we’ve had to withdraw drugs from the market that would have been safe if used according to label instructions” [Janet Woodcock, Temple University, 4/4/00]
AUG 09, 2001 ---and don’t hurt your product
Anticholesterol Drug Pulled After Link to 31 Deaths
With Baycol, however, reports of serious rhabdomyolysis were about 10 times as frequent as with the other statins, Dr. Jenkins said.
"Baycol really stood out as being different," he said. "Baycol did not offer any benefits beyond those of the other statins. But it carried a potential risk, and that leads to a conclusion that it is no longer safe to be marketed."
Import Alerts- drugs with RM plans
Top 20 ---and don’t hurt your product
Risk Management is the process of minimizing risks throughout a product’s lifecycle to optimize the benefit/risk balance
adherence to program elements
Levels may go – concept of progressive interventions will stay
Risk Management ---and don’t hurt your product
Willing-ness to Use
Perception of Risk
1. Additional Study
3. How to manage Risks?
1. Define the problem
What messages will be necessary to influence behavior
Will “information” be sufficient? Do we need “behavioral control systems”?
Select Vehicles to Maximize Communication Goal May need a combination of Vehicles
RM System Design ---and don’t hurt your product
B/RM Planning & Design
How do we slot the risk-control level for any drug?
Multi-Function Registry ---and don’t hurt your product
MD or Patient
Compilation & Reporting
May need iterative education and motivation
Too much work to use
Too Much RM
Will benefit and protect patient,
Willing to try
Drug may hurt patient
Too risky to try
Too Little RM
Example of Cholesterol-Lowering Medication
*Scott-Levin data 10/00-3/01 showing 45% of patients continuing on medication each month from prior month.
**Internal calculations using program costs, expected returns, and Scott-Levin Rx data.
+Scott-Levin data from 10/00-3/01 for monthly adherence of statin users.
++Adherence rates observed among Adhere program participants.
1. RMP Outline
2. Methods of Evaluation:
These tasks should be completed for presentation
Theme: Risk Avoidance Involvement Logo as Reminder
Adapted from Ostrove, 2001
Adapted from Ostrove, 2001
FDA on its initiative…may exempt or defer any MG content or format requirement on the basis that it is inapplicable, unnecessary or contrary to patients’ best interest
Measure Behavioral Impacts
Measure, knowledge, beliefs, intentions, reported behavior