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FOR IMMEDIATE RELEASE |
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The Food and Drug Administration (FDA) is announcing the availability of three draft guidances to help industry develop risk management activities when needed for some drugs and biological products. The documents, entitled "Premarketing Risk Assessment," "Development and Use of Risk Minimization Action Plans," and "Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment," address safety issues that can arise throughout a product's entire lifecycle, including its development, the review and approval process, and after it is available on the market.
"These draft documents are part of much broader, ongoing, and comprehensive efforts by our agency to provide guidance to industry on measures that can be used to minimize the risks while preserving the benefits of medical products," said Dr. Lester M. Crawford, the Acting Comissioner of Food and Drugs. "These guidances, when finalized, will help safeguard the health of our consumers and patients."
The draft guidances were produced in part to fulfill FDA's commitment to certain risk management performance goals agreed to when the Prescription Drug User Fee Act was reauthorized in June 2002. They are based on three concept papers released on March 7, 2003, and on comments the agency received in and following a subsequent public workshop.
The draft guidances describe additional safety testing, monitoring, and interventions that may be helpful in selected circumstances and address premarket risk assessment; the development, implementation, and evaluation of risk minimization action plans (called RiskMAPs); and good pharmacovigilance practices and assessment of reported adverse events.
For example, the draft guidance on premarket risk assessment focuses on measures sponsors might consider during the later stages of clinical development of products that are known to, or might, present special safety issues. The recommended risk assessment strategies for such cases can include long-term controlled safety studies, enrollment of diversified patient population, and phase 3 trials with multiple dose levels.
The draft guidance on development and use of RiskMAPs describes how industry can address specific risk-related goals and objectives.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 products. The draft guidance on heightened postmarketing vigilance identifies recommended reporting and analytical practices involving adverse events associated with high-risk drug and biological products.
In releasing these draft guidances, FDA seeks comments on its efforts to help industry increase both product benefits and safety without undue burdens on product developers, health care practitioners, and patients. As new products are developed, FDA recommends that sponsors seek to identify risk signals as early as possible in a product's development cycle, evaluate them, and communicate and manage them as thoroughly and efficiently as possible.
The agency invites written or electronic comments on the draft guidances. The comment period closes on Tuesday, July 6, 2004. FDA is specifically soliciting public comment on how to best characterize the types and levels of risk that might suggest the need for a risk management plan. General comments on agency guidance documents are welcome at any time.
The draft guidances, when finalized, will represent the agency's current thinking on these topics. They will not create or confer any rights for or on any person and will not be binding on FDA or the public.
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Federal Register Notice (May 5, 2004)