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FDA Issues Final Risk Minimization Guidances

MARCH 24, 2005 -- ROCKVILLE, MD -- The Food and Drug Administration (FDA) today issued three final guidance documents to help develop new ways and improve methods to assess and monitor the risks associated with drugs and biological products in clinical development and general use. The documents are part of FDA's ongoing and comprehensive efforts to minimize risks while preserving the benefits of medical products.

"As one of the five initiatives announced in November 2004 to further strengthen our drug safety program, these guidances are further evidence of FDA's commitment to transparency in risk management decision-making," said Dr. Steven Galson, Acting Director, Center for Drug Evaluation and Research. "Continuing to improve the way safety is assessed and monitored will lead to the earlier identification of safety problems and enable a more proactive approach to minimizing these risks," added Dr. Galson.

The final guidances, entitled "Premarketing Risk Assessment," "Development and Use of Risk Minimization Action Plans," and "Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment," describe additional safety testing, monitoring, and interventions that may be helpful in selected circumstances and address pre-market risk assessment; the development, implementation, and evaluation of risk minimization action plans (called RiskMAPs); and good pharmacovigilance practices and assessment of reported adverse events.

The final guidance on premarket risk assessment focuses on measures companies might consider throughout all stages of clinical development of products. For example, a section on special safety considerations describes ways that risk assessment can be tailored for those products intended to be used chronically or in children. General recommended risk assessment strategies include the use of long-term controlled safety studies, enrollment of diversified patient populations, and phase III trials with multiple dose levels. Some key components of the guidance include:

Providing specific recommendations to industry for improving the assessment and reporting of safety during drug development trials. Improving the assessment of important safety issues during registration trials and to provide best practices for analyzing and reporting data that are developed as a result of a careful pre-approval safety evaluation. Building on (but not superceding) a number of existing FDA and ICH guidances related to preapproval safety assessments.

The final guidance on development and use of RiskMAPs describes how industry can address specific risk-related goals and objectives. This guidance also suggests various tools to minimize the risks of drug and biological products. Some key components of the guidance include:

- Establishing consistent use and definition of terms, and a conceptual framework for setting up specialized systems and processes to assure product benefits exceed risks.

- Broader input from patients, health care professionals, and the public when making recommendations about whether to initiate, revise, or end risk minimization interventions.

- Evaluating RiskMAPs to assure that risk minimization efforts are successful.

The final guidance on heightened postmarketing vigilance identifies recommended reporting and analytical practices to monitor the safety concerns and risk of medical products in general use. Some key components of this guidance include:

- Describing the role of pharmacovigilance in risk management. Pharmacovigilance refers to all observational post-approval scientific and data gathering activities relating to the detection, assessment and understanding of adverse events with the goals of identifying and preventing these events to the extent possible.

- Describing elements of good pharmacovigilance practice from identifying and describing safety signals, through investigation of signals beyond case review, and interpreting signals in terms of risk.

- Describing development of pharmacovigilance plans to expedite the acquisition of new safety information for products with unusual safety signals.

The final guidances fulfill FDA's commitment to risk management performance goals as part of the reauthorization of the Prescription Drug User Fee Act in June 2002. They are based on three concept papers released on March 7, 2003, and on comments the agency received following a subsequent public workshop and publication of the draft guidances in May, 2004.

To view the guidances please go to the following addresses:

Premarketing Risk Assessment:
Development and Use of Risk Minimization Action Plans:
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment:

Source: The Food and Drug Administration

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