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Risk Management
The Latest on Risk Management

by Louis A. Morris, Pharmaceutical Executive, May 2004

ust as the May issue of Pharmaceutical Executive went to press, FDA released draft guidance on risk management. The guidance follows the concept
paper FDA published in March 2003, which was the focus of my recent Pharma Exec article ("Risk Management Mandate," May 2004). The following describes changes in the recent FDA guidance paper compared with the original concept paper.

The title (and focus) of the original paper, "Risk Management," has been changed to "Risk Minimization Action Plans (RiskMAPs)." This clarifies that the planning

  purpose for methods of controlling risks is a separate part of the risk management process (which covers the assessment and evaluation of risks as well as the planning process). Further, it makes explicit the assumption that we may not be able to totally manage risks, but we should seek to minimize hazards to the fullest extent possible.

FDA proposes that risk management is an iterative process of assessing the risk-benefit balance, developing tools to minimize risks while preserving its benefits, evaluating tool effectiveness and the risk-benefit balance, and making necessary adjustments to the program.

FDA suggests that routine risk management will be sufficient for most products and a RiskMAP will not be needed. FDA may ask a pharma company to prepare a RiskMAP on the agency's own interpretation of the risk information provided by the NDA (new drug application) sponsor. FDA or the pharma company's decision to prepare a RiskMAP should be based on:

  • Nature and rate of known risks versus benefits
  • Preventability of harm (drugs with avoidable or minimized harm as preferable candidates)
  • Ability to increasing benefits relative to risks.

Makers of Schedule II controlled substances should consider RiskMAP for their products.

FDA has now included limited promotional techniques (such as product sampling and direct-to-consumer advertising) as an "acceptable targeted education and outreach" tool for risk minimization. In addition, FDA states that educational tools can be used to explain how to use products that not only minimize risks but maximize benefits .

The agency has titled "systems that guide the circumstances of individual prescribing, dispensing, and/or use" as "reminder systems" and "restricted access systems" as "performance-linked systems."

FDA recommends that pharma companies consider maintaining the widest possible access with the least burden to the healthcare system when selecting tools. Companies should also seek to avoid "unintended consequences" that obstruct risk minimization and product benefit.

The agency suggests that both the RiskMAP and the individual tools be evaluated separately. As with the original concept paper, FDA recommends "two different quantitative, representative, and minimally biased evaluation methods for each critical RiskMAP goal." It also recommends that sponsors evaluate (pretest) their tools before implementation.

FDA plans to maintain a RiskMAP website on which it intends to post summaries of RiskMAP evaluations that do not identify the sponsors' particular products.

The FDA draft guidance also contains the proposed format for the RiskMAP as well as the progress reports.

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